<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title>Pharmaceutical Guideline</title><description>Pharmaceutical regulatory guidance for QA, QC and manufacturing professionals: GMP, ICH, PIC/S, 21 CFR, Schedule M, validation and pharmacopoeial standards.</description><link>https://www.pharmaceuticalguideline.com/</link><language>en</language><item><title>Understanding the 2026 EU Pharma Legislation Overhaul: Key Insights for Compliance Teams</title><link>https://www.pharmaceuticalguideline.com/post/understanding-the-2026-eu-pharma-legislation-overhaul-key-insights-for-compliance-teams/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/understanding-the-2026-eu-pharma-legislation-overhaul-key-insights-for-compliance-teams/</guid><description>The European Union is preparing for the most significant change in pharmaceutical regulation in over 20 years. On December 11, 2025, political agreement was reached on a new set of rules that will reshape how medicines for human use are developed, approved, and monitored across the EU. The final texts of a new regulation and directive were published in March 2026, marking a major overhaul of the EU pharma legislation framework.This update affects every stage of a medicine’s lifecycle, from early</description><pubDate>Wed, 08 Apr 2026 15:42:24 GMT</pubDate></item><item><title>Ensuring Pharmaceutical Data Integrity in Manufacturing</title><link>https://www.pharmaceuticalguideline.com/post/ensuring-pharmaceutical-data-integrity-in-manufacturing/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/ensuring-pharmaceutical-data-integrity-in-manufacturing/</guid><description>In pharmaceutical manufacturing, maintaining the accuracy and reliability of data is not just a regulatory requirement - it is a cornerstone of patient safety and product quality. I have seen firsthand how lapses in data integrity can lead to costly recalls, regulatory actions, and most importantly, risks to public health. That is why I want to share practical insights on how to ensure pharmaceutical data integrity throughout the manufacturing process.Data integrity means that all data generated</description><pubDate>Tue, 07 Apr 2026 00:00:18 GMT</pubDate></item><item><title>Navigating the Evolving Pharmaceutical Manufacturing Landscape in 2026</title><link>https://www.pharmaceuticalguideline.com/post/navigating-the-evolving-pharmaceutical-manufacturing-landscape-in-2026/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/navigating-the-evolving-pharmaceutical-manufacturing-landscape-in-2026/</guid><description>Sterile lab with shiny metal machinery, blue lighting, control panels, and empty glass vials on a conveyor. Modern and clean</description><pubDate>Sun, 05 Apr 2026 23:30:10 GMT</pubDate></item><item><title>Understanding Pharmaceutical Compliance Guidelines in the Pharmaceutical Industry</title><link>https://www.pharmaceuticalguideline.com/post/understanding-pharmaceutical-compliance-guidelines-in-the-pharmaceutical-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/understanding-pharmaceutical-compliance-guidelines-in-the-pharmaceutical-industry/</guid><description>Compliance in the pharmaceutical industry is not just a regulatory requirement; it is the backbone of ensuring patient safety, product quality, and trust in healthcare. As someone deeply involved in pharmaceutical manufacturing and quality assurance, I understand how complex and critical compliance can be. This post aims to clarify what compliance means in this sector, why it matters, and how to navigate the often intricate landscape of pharmaceutical regulations.Pharmaceutical compliance guidel</description><pubDate>Sun, 05 Apr 2026 16:45:05 GMT</pubDate></item><item><title>Understanding Pharmaceutical Compliance Guidelines for Quality Assurance</title><link>https://www.pharmaceuticalguideline.com/post/understanding-pharmaceutical-compliance-guidelines-for-quality-assurance/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/understanding-pharmaceutical-compliance-guidelines-for-quality-assurance/</guid><description>In the pharmaceutical industry, quality assurance is not just a goal - it is a necessity. Ensuring that every product meets strict safety and efficacy standards requires a deep understanding of pharmaceutical compliance guidelines. These guidelines serve as the backbone for manufacturing processes, regulatory submissions, and overall product integrity. Today, I want to walk you through the essentials of these guidelines, explain their importance, and share practical insights on how to implement</description><pubDate>Wed, 01 Apr 2026 14:43:04 GMT</pubDate></item><item><title>Essential Pharmaceutical Compliance Guidelines Explained</title><link>https://www.pharmaceuticalguideline.com/post/essential-pharmaceutical-compliance-guidelines-explained/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/essential-pharmaceutical-compliance-guidelines-explained/</guid><description>Navigating the complex world of pharmaceutical compliance can feel overwhelming. As someone deeply involved in pharmaceutical manufacturing and quality assurance, I understand how critical it is to stay updated with the latest guidelines. These rules ensure that products are safe, effective, and meet regulatory standards worldwide. In this post, I will break down essential pharmaceutical compliance guidelines, explain their importance, and offer practical advice to help you maintain compliance i</description><pubDate>Sat, 07 Feb 2026 15:31:15 GMT</pubDate></item><item><title>Essential Guidelines for the Pharmaceutical Industry: Navigating Pharmaceutical Compliance Protocols</title><link>https://www.pharmaceuticalguideline.com/post/essential-guidelines-for-the-pharmaceutical-industry-navigating-pharmaceutical-compliance-protocols/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/essential-guidelines-for-the-pharmaceutical-industry-navigating-pharmaceutical-compliance-protocols/</guid><description>In the pharmaceutical industry, adherence to strict guidelines is not just a regulatory requirement but a cornerstone of ensuring patient safety and product efficacy. As someone deeply involved in pharmaceutical manufacturing and quality assurance, I understand how critical it is to stay updated with the latest pharmaceutical compliance protocols. These protocols help maintain high standards, reduce risks, and streamline operations. Today, I want to share essential guidelines that every professi</description><pubDate>Mon, 19 Jan 2026 03:45:06 GMT</pubDate></item><item><title>Contamination Control Strategy Guide: Ampoules, Vials &amp; Lyo (Annex 1 Compliant)</title><link>https://www.pharmaceuticalguideline.com/post/contamination-control-strategy-guide-ampoules-vials-lyo-annex-1-compliant/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/contamination-control-strategy-guide-ampoules-vials-lyo-annex-1-compliant/</guid><description>A step-by-step guide to implementing a compliant Contamination Control Strategy (CCS) for sterile injectable plants. Learn how to master Annex 1 requirements for ampoules, vials, and lyophilized products.</description><pubDate>Thu, 15 Jan 2026 17:56:09 GMT</pubDate></item><item><title>Deadline Dilemma: The Case for Extending Revised Schedule M to December 2026</title><link>https://www.pharmaceuticalguideline.com/post/deadline-dilemma-the-case-for-extending-revised-schedule-m-to-december-2026/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/deadline-dilemma-the-case-for-extending-revised-schedule-m-to-december-2026/</guid><description>As of January 2026, the Indian pharma sector faces a massive bottleneck: over 13,000 plants require inspection, yet only ~1,100 field inspectors are active. While the government has enforced Revised Schedule M, Laghu Udhyog Bharti is pushing for a vital extension until December 2026 to prevent the closure of thousands of MSMEs and ensure the continued supply of affordable medicine.</description><pubDate>Wed, 14 Jan 2026 14:32:47 GMT</pubDate></item><item><title>Enhancing Productivity and Quality in Pharmaceutical Industries</title><link>https://www.pharmaceuticalguideline.com/post/enhancing-productivity-and-quality-in-pharmaceutical-industries/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/enhancing-productivity-and-quality-in-pharmaceutical-industries/</guid><description>Improving productivity &amp; quality is critical to ensuring efficient operations, regulatory compliance &amp; the delivery of high-quality products</description><pubDate>Sun, 20 Oct 2024 03:41:39 GMT</pubDate></item><item><title>How to Utilize 5 WHY Analysis to Uncover Root Cause</title><link>https://www.pharmaceuticalguideline.com/post/how-to-utilize-5-why-analysis-to-uncover-root-cause/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/how-to-utilize-5-why-analysis-to-uncover-root-cause/</guid><description>5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry</description><pubDate>Mon, 07 Oct 2024 15:58:27 GMT</pubDate></item><item><title>Departments in the Biopharmaceutical Industry</title><link>https://www.pharmaceuticalguideline.com/post/departments-in-the-biopharmaceutical-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/departments-in-the-biopharmaceutical-industry/</guid><description>Departments in biopharmaceutical industry, its work function in details, how to get job in biopharmaceuticals, eligibility criteria, Salary.</description><pubDate>Sun, 06 Oct 2024 15:15:40 GMT</pubDate></item><item><title>How to Secure a Job in the Pharmaceutical Industry: Eligibility, Preparation, and Interview Tips</title><link>https://www.pharmaceuticalguideline.com/post/how-to-secure-a-job-in-the-pharmaceutical-industry-eligibility-preparation-and-interview-tips/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/how-to-secure-a-job-in-the-pharmaceutical-industry-eligibility-preparation-and-interview-tips/</guid><description>Its essential to not only meet the eligibility criteria but also to showcase your passion for the industry &amp; willingness to learn and grow.</description><pubDate>Mon, 09 Sep 2024 01:20:04 GMT</pubDate></item><item><title>A Standard Approach to Root Cause Identification in Pharmaceutical Investigations Using Fishbone Diagrams and Cause and Effect Analysis</title><link>https://www.pharmaceuticalguideline.com/post/a-standard-approach-to-root-cause-identification-in-pharmaceutical-investigations-using-fishbone-dia/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/a-standard-approach-to-root-cause-identification-in-pharmaceutical-investigations-using-fishbone-dia/</guid><description>By employing Fishbone Diagram, organizations can streamline investigative processes, mitigate risks, &amp; drive continuous improvement...</description><pubDate>Sun, 08 Sep 2024 01:00:08 GMT</pubDate></item><item><title>10 Essential Statistical Tools for Pharmaceutical Analysis: A Guide for Professionals</title><link>https://www.pharmaceuticalguideline.com/post/10-essential-statistical-tools-for-pharmaceutical-analysis-a-guide-for-professionals/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/10-essential-statistical-tools-for-pharmaceutical-analysis-a-guide-for-professionals/</guid><description>The use of statistical tools plays a crucial role in ensuring the quality and efficacy of pharmaceutical products.</description><pubDate>Sat, 07 Sep 2024 11:00:14 GMT</pubDate></item><item><title>How Can Human Error be Minimized in Pharmaceutical Laboratories and Analyses?</title><link>https://www.pharmaceuticalguideline.com/post/how-can-human-error-be-minimized-in-pharmaceutical-laboratories-and-analyses/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/how-can-human-error-be-minimized-in-pharmaceutical-laboratories-and-analyses/</guid><description>Human error is an unavoidable factor, it poses a significant threat to the credibility and dependability of laboratory findings.</description><pubDate>Sat, 07 Sep 2024 03:35:55 GMT</pubDate></item><item><title>5WHY Analysis for Pharmaceutical: Uncovering Root Causes Effectively</title><link>https://www.pharmaceuticalguideline.com/post/uncovering-the-root-cause-a-professional-guide-to-conducting-a-5-why-analysis-in-pharmaceutical/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/uncovering-the-root-cause-a-professional-guide-to-conducting-a-5-why-analysis-in-pharmaceutical/</guid><description>The 5 WHY analysis stands out as a highly efficient tool for root cause analysis</description><pubDate>Wed, 04 Sep 2024 10:37:40 GMT</pubDate></item><item><title>Essential 10 Steps for Good Manufacturing Practice in Pharmaceutical Industry</title><link>https://www.pharmaceuticalguideline.com/post/10-steps-to-ensure-gmp-compliance-in-pharmaceutical-drug-production-key-requirements-auditing-ins/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/10-steps-to-ensure-gmp-compliance-in-pharmaceutical-drug-production-key-requirements-auditing-ins/</guid><description>In the pharmaceutical industry, maintaining Good Manufacturing Practices (GMP) compliance is vital to ensure the safety, quality, and efficacy of pharmaceutical products. Pharmaceutical manufacturers adhere to strict guidelines to meet regulatory standards and guarantee the integrity of their operations. Let</description><pubDate>Sun, 01 Sep 2024 15:44:00 GMT</pubDate></item><item><title>Photostability Testing of New Drug Products</title><link>https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-products/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-products/</guid><description>First Read Photostability Testing of New Drug Substances and Products First Read Photostability Testing of New Drug Substances Photostability Testing of</description><pubDate>Wed, 26 Jul 2023 00:00:00 GMT</pubDate></item><item><title>Photostability Testing of New Drug Substances</title><link>https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-substances/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-substances/</guid><description>drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.</description><pubDate>Tue, 25 Jul 2023 15:57:30 GMT</pubDate></item><item><title>Photostability Testing of New Drug Substances and Products</title><link>https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-substances-and-products/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/photostability-testing-of-new-drug-substances-and-products/</guid><description>Photostability Testing of New Drug Substances and Products in pharmaceutical industry</description><pubDate>Sun, 23 Jul 2023 07:22:45 GMT</pubDate></item><item><title>Code of Federal Regulations, CFR</title><link>https://www.pharmaceuticalguideline.com/post/code-of-federal-regulations-cfr/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/code-of-federal-regulations-cfr/</guid><description>The list of titles of the Code of Federal Regulations The 21 CFR is the Title 21 for Food and Drugs</description><pubDate>Mon, 01 May 2023 03:40:24 GMT</pubDate></item><item><title>Hetero Drugs Ltd. Job Opening</title><link>https://www.pharmaceuticalguideline.com/post/hetero-drugs-ltd-job-opening/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/hetero-drugs-ltd-job-opening/</guid><description>Updated: May 1, 2023 Hetero Drugs Ltd. Job Opening for GENERAL MANAGER QUALITY CONTROL</description><pubDate>Sun, 30 Apr 2023 14:01:43 GMT</pubDate></item><item><title>Intas Pharmaceuticals, SEZ Ahmedabad Job Opening</title><link>https://www.pharmaceuticalguideline.com/post/intas-pharmaceuticals-sez-ahmedabad/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/intas-pharmaceuticals-sez-ahmedabad/</guid><description>Intas Pharmaceuticals, SEZ Ahmedabad Job opening for...</description><pubDate>Sat, 29 Apr 2023 13:14:07 GMT</pubDate></item><item><title>Alembic Pharma Vadodara, Job Opening</title><link>https://www.pharmaceuticalguideline.com/post/alembic-pharma-vadodara-job-opening/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/alembic-pharma-vadodara-job-opening/</guid><description>Alembic Pharma Vadodara Job Opening for...</description><pubDate>Sat, 29 Apr 2023 11:37:43 GMT</pubDate></item><item><title>Mepro Pharmaceuticals Pvt Ltd, Job Opening</title><link>https://www.pharmaceuticalguideline.com/post/mepro-pharmaceuticals-pvt-ltd-job-opening/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/mepro-pharmaceuticals-pvt-ltd-job-opening/</guid><description>Mepro Pharmaceuticals Pvt Ltd, Job Opening...</description><pubDate>Fri, 21 Apr 2023 06:33:57 GMT</pubDate></item><item><title>Strides Pharma -Walk-In Drive for WOMEN on 23 APR 23</title><link>https://www.pharmaceuticalguideline.com/post/strides-pharma-walk-in-drive-for-women-on-23-apr-23/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/strides-pharma-walk-in-drive-for-women-on-23-apr-23/</guid><description>Strides Pharma -Walk-In Drive for WOMEN on 23 APR 23 Mega Walk-In Drive-Strides Pharma-Bangalore “Recruit HER”</description><pubDate>Thu, 20 Apr 2023 06:51:46 GMT</pubDate></item><item><title>Macleods Pharmaceuticals, Walk-In Interview On 2 April 2023</title><link>https://www.pharmaceuticalguideline.com/post/macleods-pharmaceuticals-walk-in-interview-on-2-april-2023/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/macleods-pharmaceuticals-walk-in-interview-on-2-april-2023/</guid><description>Macleods Pharmaceuticals, Walk-In Interview On 2 April 2023</description><pubDate>Thu, 30 Mar 2023 17:08:34 GMT</pubDate></item><item><title>Biophore India Pharmaceuticals Pvt. Ltd. Walk-In Interview On 30 March to 1 April 2023</title><link>https://www.pharmaceuticalguideline.com/post/biophore-india-pharmaceuticals-pvt-ltd-walk-in-interview-on-30-march-to-1-april-2023/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/biophore-india-pharmaceuticals-pvt-ltd-walk-in-interview-on-30-march-to-1-april-2023/</guid><description>Biophore India Pharmaceuticals Pvt. Ltd. Walk-In Interview On 30th March to 1 April 2023</description><pubDate>Wed, 29 Mar 2023 17:42:03 GMT</pubDate></item><item><title>Sun Pharma- Walk-In Interview On 31-MAR-23</title><link>https://www.pharmaceuticalguideline.com/post/sun-pharma-walk-in-interview-on-31-mar-23/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sun-pharma-walk-in-interview-on-31-mar-23/</guid><description>Sun Pharma- Walk-In Interview On 31-MAR-23</description><pubDate>Wed, 29 Mar 2023 15:21:05 GMT</pubDate></item><item><title>Cipla pharmaceuticals limited Walk-In Interview on 31 March 2023</title><link>https://www.pharmaceuticalguideline.com/post/cipla-pharmaceuticals-limited-walk-in-interview-on-31-march-2023/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/cipla-pharmaceuticals-limited-walk-in-interview-on-31-march-2023/</guid><description>Cipla pharmaceuticals limited Walk-In Interview on 31 March 2023</description><pubDate>Tue, 28 Mar 2023 16:38:37 GMT</pubDate></item><item><title>Mega Walk-In by Andhra Pradesh State Skill Development Corporation on 31-MAR-23</title><link>https://www.pharmaceuticalguideline.com/post/mega-walk-in-by-andhra-pradesh-state-skill-development-corporation-on-31-mar-23/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/mega-walk-in-by-andhra-pradesh-state-skill-development-corporation-on-31-mar-23/</guid><description>Mega Walk-In by Andhra Pradesh State Skill Development Corporation on 31-MAR-23 Andhra Pradesh State Skill Development Corporation (APSSDC), Employment…</description><pubDate>Mon, 27 Mar 2023 16:17:12 GMT</pubDate></item><item><title>Glenmark Pharmaceuticals Job Opening for Quality Assurance</title><link>https://www.pharmaceuticalguideline.com/post/glenmark-pharmaceuticals-job-opening-for-quality-assurance/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/glenmark-pharmaceuticals-job-opening-for-quality-assurance/</guid><description>Glenmark Pharmaceuticals Job Opening for Quality Assurance</description><pubDate>Mon, 27 Mar 2023 16:01:23 GMT</pubDate></item><item><title>Teva Pharmaceuticals Hiring Clinical Research team for Bangalore/ Mumbai location</title><link>https://www.pharmaceuticalguideline.com/post/teva-pharmaceuticals-hiring-clinical-research-team-for-bangalore--mumbai-location/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/teva-pharmaceuticals-hiring-clinical-research-team-for-bangalore--mumbai-location/</guid><description>Teva Pharmaceuticals Hiring Clinical Research team for Bangalore/ Mumbai location.</description><pubDate>Sun, 26 Mar 2023 17:17:07 GMT</pubDate></item><item><title>Nectar Lifesciences Limited, Walk-In Interview on 09-APR-23</title><link>https://www.pharmaceuticalguideline.com/post/nectar-lifesciences-limited-walk-in-interview-on-09-apr-23/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/nectar-lifesciences-limited-walk-in-interview-on-09-apr-23/</guid><description>Nectar Lifesciences Limited, Walk-In Interview for Derabassi Plant on 09-APR-23 at HOTEL WINWAY, 164/1, RNT MARG, INDORE</description><pubDate>Sun, 26 Mar 2023 13:19:22 GMT</pubDate></item><item><title>Changes in 21 CFR Part 11 Subpart C, Electronic Signatures</title><link>https://www.pharmaceuticalguideline.com/post/changes-in-21-cfr-part-11-subpart-c-electronic-signatures/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/changes-in-21-cfr-part-11-subpart-c-electronic-signatures/</guid><description>Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…</description><pubDate>Sat, 04 Mar 2023 06:30:32 GMT</pubDate></item><item><title>Shutdown of European Pharmacopoeia 10th Edition</title><link>https://www.pharmaceuticalguideline.com/post/shutdown-of-european-pharmacopoeia-10th-edition/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/shutdown-of-european-pharmacopoeia-10th-edition/</guid><description>European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.</description><pubDate>Tue, 14 Feb 2023 14:34:25 GMT</pubDate></item><item><title>ICH Q9(R1) Quality Risk Management: Summary &amp; Changes</title><link>https://www.pharmaceuticalguideline.com/post/quality-risk-management-ich-q9-r1/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/quality-risk-management-ich-q9-r1/</guid><description>Intended to provide guidance on the principles &amp; examples of tools for quality risk management that can be applied to different aspects...</description><pubDate>Thu, 26 Jan 2023 11:58:04 GMT</pubDate></item><item><title>FDA Dosage &amp; Administration Labeling Guidance — Docket No.</title><link>https://www.pharmaceuticalguideline.com/post/dosage-and-administration-section-of-labeling-for-human-prescription-drug-and-biological-products/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/dosage-and-administration-section-of-labeling-for-human-prescription-drug-and-biological-products/</guid><description>Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products</description><pubDate>Fri, 13 Jan 2023 14:21:01 GMT</pubDate></item><item><title>New paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619</title><link>https://www.pharmaceuticalguideline.com/post/new-paragraph-on-control-of-n-nitrosamines-ph-eur-revised-general-monograph-2034-and-2619/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/new-paragraph-on-control-of-n-nitrosamines-ph-eur-revised-general-monograph-2034-and-2619/</guid><description>Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines</description><pubDate>Sun, 08 Jan 2023 06:11:41 GMT</pubDate></item><item><title>Pastes</title><link>https://www.pharmaceuticalguideline.com/post/pastes/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/pastes/</guid><description>Pastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for</description><pubDate>Tue, 03 Jan 2023 00:00:00 GMT</pubDate></item><item><title>WHO TRS 1044 (2022): 56th Report Annexes &amp; PDF</title><link>https://www.pharmaceuticalguideline.com/post/who-technical-report-series-trs-1044-2022-56th-report/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/who-technical-report-series-trs-1044-2022-56th-report/</guid><description>WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report</description><pubDate>Mon, 26 Dec 2022 12:00:24 GMT</pubDate></item><item><title>Signal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques</title><link>https://www.pharmaceuticalguideline.com/post/signal-to-noise-ratio-revision-of-ph-eur-general-chapter-chromatographic-separation-techniques/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/signal-to-noise-ratio-revision-of-ph-eur-general-chapter-chromatographic-separation-techniques/</guid><description>Ph. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.</description><pubDate>Wed, 21 Dec 2022 11:24:55 GMT</pubDate></item><item><title>Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1</title><link>https://www.pharmaceuticalguideline.com/post/revised-general-chapter-on-rubber-closures-published-in-the-ph-eur-supplement-11-1/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/revised-general-chapter-on-rubber-closures-published-in-the-ph-eur-supplement-11-1/</guid><description>EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders</description><pubDate>Mon, 19 Dec 2022 14:14:02 GMT</pubDate></item><item><title>IMPLANTS</title><link>https://www.pharmaceuticalguideline.com/post/implants/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/implants/</guid><description>Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years</description><pubDate>Sun, 18 Dec 2022 13:40:03 GMT</pubDate></item><item><title>OTHER NONMONOGRAPHED WATERS</title><link>https://www.pharmaceuticalguideline.com/post/other-nonmonographed-waters/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/other-nonmonographed-waters/</guid><description>In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...</description><pubDate>Fri, 16 Dec 2022 00:20:02 GMT</pubDate></item><item><title>WATER FOR BACTERIAL ENDOTOXINS TEST</title><link>https://www.pharmaceuticalguideline.com/post/water-for-bacterial-endotoxins-test/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/water-for-bacterial-endotoxins-test/</guid><description>WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.</description><pubDate>Thu, 15 Dec 2022 14:49:41 GMT</pubDate></item><item><title>Pharmaceutical Dosage Form - Gums</title><link>https://www.pharmaceuticalguideline.com/post/_gums/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/_gums/</guid><description>Medicated gum is a pliable dosage form that is designed to be chewed rather than swallowed. it Release the drug substances into the saliva.</description><pubDate>Wed, 07 Dec 2022 00:25:02 GMT</pubDate></item><item><title>AMMONIA FREE WATER</title><link>https://www.pharmaceuticalguideline.com/post/ammonia-free-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/ammonia-free-water/</guid><description>AMMONIA FREE WATER From a functional standpoint, Ammonia Free Water must have a negligible ammonia concentration to avoid interference in tests sensitive</description><pubDate>Wed, 07 Dec 2022 00:00:00 GMT</pubDate></item><item><title>OXYGEN FREE WATER</title><link>https://www.pharmaceuticalguideline.com/post/oxygen-free-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/oxygen-free-water/</guid><description>OXYGEN FREE WATER Oxygen-Free Water is Purified Water that has been treated to remove or reduce dissolved oxygen. Such treatment could involve deaerating</description><pubDate>Tue, 06 Dec 2022 00:00:00 GMT</pubDate></item><item><title>LOSS ON IGNITION</title><link>https://www.pharmaceuticalguideline.com/post/loss-on-ignition/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/loss-on-ignition/</guid><description>Determining the percentage of test material that is volatilized &amp; driven off under the conditions specified.</description><pubDate>Sat, 03 Dec 2022 08:56:02 GMT</pubDate></item><item><title>DEAERATED WATER</title><link>https://www.pharmaceuticalguideline.com/post/deaerated-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/deaerated-water/</guid><description>Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...</description><pubDate>Tue, 29 Nov 2022 13:32:05 GMT</pubDate></item><item><title>HIGH-PURITY WATER</title><link>https://www.pharmaceuticalguideline.com/post/high-purity-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/high-purity-water/</guid><description>High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.</description><pubDate>Tue, 29 Nov 2022 00:26:02 GMT</pubDate></item><item><title>FILTERED WATER</title><link>https://www.pharmaceuticalguideline.com/post/filtered-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/filtered-water/</guid><description>Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.</description><pubDate>Mon, 28 Nov 2022 12:11:06 GMT</pubDate></item><item><title>Loss on Drying (LOD): Formula, Procedure &amp; USP Limits</title><link>https://www.pharmaceuticalguideline.com/post/loss-on-drying/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/loss-on-drying/</guid><description>Loss on drying is the loss of mass after drying under specified conditions, calculated as a percentage (m/m).</description><pubDate>Tue, 22 Nov 2022 17:11:44 GMT</pubDate></item><item><title>DEIONIZED DISTILLED WATER</title><link>https://www.pharmaceuticalguideline.com/post/deionized-distilled-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/deionized-distilled-water/</guid><description>This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.</description><pubDate>Sun, 20 Nov 2022 00:30:04 GMT</pubDate></item><item><title>DEIONIZED WATER</title><link>https://www.pharmaceuticalguideline.com/post/deionized-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/deionized-water/</guid><description>Deionized Water is produced by an ion-exchange process in which the cations &amp; anions are replaced with H+ &amp; OH− ions by use of ion-exchange</description><pubDate>Sat, 19 Nov 2022 13:36:05 GMT</pubDate></item><item><title>FRESHLY DISTILLED WATER</title><link>https://www.pharmaceuticalguideline.com/post/freshly-distilled-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/freshly-distilled-water/</guid><description>FRESHLY DISTILLED WATER Freshly Distilled Water or “recently distilled water” is produced in the same manner as Distilled Water and should be used soon</description><pubDate>Thu, 10 Nov 2022 00:00:00 GMT</pubDate></item><item><title>DISTILLED WATER</title><link>https://www.pharmaceuticalguideline.com/post/distilled-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/distilled-water/</guid><description>Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.</description><pubDate>Tue, 08 Nov 2022 17:21:40 GMT</pubDate></item><item><title>CARBON DIOXIDE-FREE WATER</title><link>https://www.pharmaceuticalguideline.com/post/carbon-dioxide-free-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/carbon-dioxide-free-water/</guid><description>Carbon dioxide-free water is defined in the Reagents, Indicators, and Solutions section of USP–NF as Purified Water that has been vigorously boiled for</description><pubDate>Wed, 02 Nov 2022 00:00:00 GMT</pubDate></item><item><title>LOTIONS</title><link>https://www.pharmaceuticalguideline.com/post/lotions/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/lotions/</guid><description>LOTIONS Lotions are an emulsified liquid dosage form intended for external application to the skin. Historically, some topical suspensions such as</description><pubDate>Mon, 31 Oct 2022 00:00:00 GMT</pubDate></item><item><title>CREAMS</title><link>https://www.pharmaceuticalguideline.com/post/creams/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/creams/</guid><description>Creams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes</description><pubDate>Sat, 29 Oct 2022 15:40:49 GMT</pubDate></item><item><title>DRINKING WATER</title><link>https://www.pharmaceuticalguideline.com/post/drinking-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/drinking-water/</guid><description>Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.</description><pubDate>Wed, 26 Oct 2022 14:19:01 GMT</pubDate></item><item><title>SOURCE WATER CONSIDERATIONS</title><link>https://www.pharmaceuticalguideline.com/post/source-water-considerations/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/source-water-considerations/</guid><description>Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.</description><pubDate>Sun, 23 Oct 2022 18:48:32 GMT</pubDate></item><item><title>Multiple Endpoints in Clinical Trials Guidance for Industry</title><link>https://www.pharmaceuticalguideline.com/post/multiple-endpoints-in-clinical-trials-guidance-for-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/multiple-endpoints-in-clinical-trials-guidance-for-industry/</guid><description>GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…</description><pubDate>Sat, 22 Oct 2022 17:15:10 GMT</pubDate></item><item><title>Nonmonographed Waters</title><link>https://www.pharmaceuticalguideline.com/post/nonmonographed-waters/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/nonmonographed-waters/</guid><description>These waters can also be used in pharmaceutical processing steps &amp; also as a starting material for further purification or testing purposes.</description><pubDate>Fri, 21 Oct 2022 16:21:32 GMT</pubDate></item><item><title>STERILE WATER FOR INHALATION</title><link>https://www.pharmaceuticalguideline.com/post/sterile-water-for-inhalation/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sterile-water-for-inhalation/</guid><description>STERILE WATER FOR INHALATION is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of</description><pubDate>Mon, 17 Oct 2022 00:00:00 GMT</pubDate></item><item><title>STERILE WATER FOR IRRIGATION</title><link>https://www.pharmaceuticalguideline.com/post/sterile-water-for-irrigation/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sterile-water-for-irrigation/</guid><description>is Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L &amp; allow rapid delivery of their content</description><pubDate>Sun, 16 Oct 2022 16:59:11 GMT</pubDate></item><item><title>BACTERIOSTATIC WATER FOR INJECTION</title><link>https://www.pharmaceuticalguideline.com/post/bacteriostatic-water-for-injection/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/bacteriostatic-water-for-injection/</guid><description>BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.</description><pubDate>Fri, 14 Oct 2022 18:30:00 GMT</pubDate></item><item><title>Sterile Water for Injection</title><link>https://www.pharmaceuticalguideline.com/post/sterile-water-for-injection/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sterile-water-for-injection/</guid><description>Sterile Water for Injection is water for Injection packaged and rendered sterile.</description><pubDate>Fri, 14 Oct 2022 15:45:05 GMT</pubDate></item><item><title>STERILE PURIFIED WATER</title><link>https://www.pharmaceuticalguideline.com/post/sterile-purified-water/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sterile-purified-water/</guid><description>Sterile Purified Water is Purified Water, packaged and rendered sterile.</description><pubDate>Mon, 10 Oct 2022 16:01:12 GMT</pubDate></item><item><title>Size, Shape, and other physical Attributes of Generic Tablets and capsules</title><link>https://www.pharmaceuticalguideline.com/post/size-shape-and-other-physical-attributes-of-generic-tablets-and-capsules/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/size-shape-and-other-physical-attributes-of-generic-tablets-and-capsules/</guid><description>US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines</description><pubDate>Sun, 09 Oct 2022 17:06:12 GMT</pubDate></item><item><title>Sterile Monographed Waters</title><link>https://www.pharmaceuticalguideline.com/post/sterile-monographed-waters/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/sterile-monographed-waters/</guid><description>Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized</description><pubDate>Fri, 07 Oct 2022 00:00:00 GMT</pubDate></item><item><title>VOLUMETRIC APPARATUS</title><link>https://www.pharmaceuticalguideline.com/post/volumetric-apparatus/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/volumetric-apparatus/</guid><description>Most of the volumetric apparatus available in the United States are calibrated at 20°, and the National Institute of Standards and Technology NIST has</description><pubDate>Wed, 05 Oct 2022 00:00:00 GMT</pubDate></item><item><title>Emulsions</title><link>https://www.pharmaceuticalguideline.com/post/emulsions/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/emulsions/</guid><description>An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents</description><pubDate>Tue, 04 Oct 2022 15:16:04 GMT</pubDate></item><item><title>Pure Steam</title><link>https://www.pharmaceuticalguideline.com/post/pure-steam/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/pure-steam/</guid><description>Pure Steam— is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or</description><pubDate>Mon, 03 Oct 2022 00:00:00 GMT</pubDate></item><item><title>Water for Hemodialysis</title><link>https://www.pharmaceuticalguideline.com/post/water-for-hemodialysis/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/water-for-hemodialysis/</guid><description>Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.</description><pubDate>Sat, 01 Oct 2022 13:29:01 GMT</pubDate></item><item><title>Water for Injection</title><link>https://www.pharmaceuticalguideline.com/post/water-for-injection/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/water-for-injection/</guid><description>WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled</description><pubDate>Tue, 27 Sep 2022 16:08:02 GMT</pubDate></item><item><title>Purified Water Monograph</title><link>https://www.pharmaceuticalguideline.com/post/purified-water-monograph/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/purified-water-monograph/</guid><description>Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION</description><pubDate>Sun, 25 Sep 2022 00:00:00 GMT</pubDate></item><item><title>Purified Water [PW]</title><link>https://www.pharmaceuticalguideline.com/post/purified-water-pw/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/purified-water-pw/</guid><description>PW is used as an excipient in the production of nonparenteral preparations &amp; in other pharma applications, such as cleaning of equipment.</description><pubDate>Sat, 24 Sep 2022 16:32:03 GMT</pubDate></item><item><title>WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES</title><link>https://www.pharmaceuticalguideline.com/post/waters-used-for-pharmaceutical-manufacturing-and-testing-purposes/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/waters-used-for-pharmaceutical-manufacturing-and-testing-purposes/</guid><description>WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES</description><pubDate>Fri, 23 Sep 2022 16:26:23 GMT</pubDate></item><item><title>Periodic Review and Requalification</title><link>https://www.pharmaceuticalguideline.com/post/periodic-review-and-requalification/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/periodic-review-and-requalification/</guid><description>Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained</description><pubDate>Thu, 22 Sep 2022 00:00:00 GMT</pubDate></item><item><title>Performance Qualification (PQ): Protocol, Steps &amp; Examples</title><link>https://www.pharmaceuticalguideline.com/post/performance-qualification-pq/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/performance-qualification-pq/</guid><description>To check the equipment etc. operates consistently &amp; gives reproducibility within defined specifications &amp; parameters, for prolonged periods</description><pubDate>Fri, 16 Sep 2022 16:14:05 GMT</pubDate></item><item><title>Operational Qualification (OQ): Protocol, Tests &amp; Examples</title><link>https://www.pharmaceuticalguideline.com/post/operational-qualification-oq/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/operational-qualification-oq/</guid><description>Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.</description><pubDate>Wed, 14 Sep 2022 17:00:34 GMT</pubDate></item><item><title>Installation Qualification [IQ]</title><link>https://www.pharmaceuticalguideline.com/post/installation-qualification-iq/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/installation-qualification-iq/</guid><description>The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.</description><pubDate>Sun, 11 Sep 2022 13:38:03 GMT</pubDate></item><item><title>Site Acceptance Test [SAT]</title><link>https://www.pharmaceuticalguideline.com/post/site-acceptance-test-sat/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/site-acceptance-test-sat/</guid><description>Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.</description><pubDate>Fri, 09 Sep 2022 14:46:06 GMT</pubDate></item><item><title>Major Equipment of Tablets and Capsules Manufacturing</title><link>https://www.pharmaceuticalguideline.com/post/major-equipment-of-tablets-and-capsules-manufacturing/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/major-equipment-of-tablets-and-capsules-manufacturing/</guid><description>List of Major Equipment of Tablets and Capsules Manufacturing</description><pubDate>Mon, 05 Sep 2022 15:56:25 GMT</pubDate></item><item><title>Factory Acceptance Test (FAT) in Pharma: Checklist &amp; Scope</title><link>https://www.pharmaceuticalguideline.com/post/factory-acceptance-test-fat/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/factory-acceptance-test-fat/</guid><description>Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.</description><pubDate>Thu, 25 Aug 2022 17:11:03 GMT</pubDate></item><item><title>What is Difference between Quality Control and Quality Assurance?</title><link>https://www.pharmaceuticalguideline.com/post/what-is-difference-between-quality-control-and-quality-assurance/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/what-is-difference-between-quality-control-and-quality-assurance/</guid><description>What is Difference between Quality Control and Quality Assurance?</description><pubDate>Wed, 24 Aug 2022 18:56:29 GMT</pubDate></item><item><title>Design Qualification [DQ]</title><link>https://www.pharmaceuticalguideline.com/post/design-qualification-dq/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/design-qualification-dq/</guid><description>Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…</description><pubDate>Thu, 18 Aug 2022 16:40:18 GMT</pubDate></item><item><title>0.1N &amp; 0.1M HCl Preparation: Formula + Calculation Guide</title><link>https://www.pharmaceuticalguideline.com/post/calculation-of-0-1n-or-0-1m-hydrochloric-acid-hcl/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/calculation-of-0-1n-or-0-1m-hydrochloric-acid-hcl/</guid><description>How to calculate the requirement of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl Solution?</description><pubDate>Tue, 16 Aug 2022 18:06:05 GMT</pubDate></item><item><title>User Requirement Specification (URS) in Pharma + Template</title><link>https://www.pharmaceuticalguideline.com/post/user-requirements-specification-urs/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/user-requirements-specification-urs/</guid><description>User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry</description><pubDate>Sun, 14 Aug 2022 16:43:10 GMT</pubDate></item><item><title>Basic Flow of Qualification [Equipment, Utility, System, Facility] in Pharmaceutical Industry</title><link>https://www.pharmaceuticalguideline.com/post/basic-flow-of-qualification-equipment-utility-system-facility-in-pharmaceutical-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/basic-flow-of-qualification-equipment-utility-system-facility-in-pharmaceutical-industry/</guid><description>Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ</description><pubDate>Fri, 12 Aug 2022 00:00:00 GMT</pubDate></item><item><title>Policy Regarding N-acetyl-L-cysteine</title><link>https://www.pharmaceuticalguideline.com/post/policy-regarding-n-acetyl-l-cysteine/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/policy-regarding-n-acetyl-l-cysteine/</guid><description>Guidance for Industry: Policy Regarding N-acetyl-L-cysteine, The New Guidance Document by USFDA (United States Food and Drug Administration)</description><pubDate>Tue, 09 Aug 2022 17:11:04 GMT</pubDate></item><item><title>VALIDATION MASTER PLAN (VMP)</title><link>https://www.pharmaceuticalguideline.com/post/validation-master-plan-vmp/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/validation-master-plan-vmp/</guid><description>VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.</description><pubDate>Mon, 08 Aug 2022 15:55:06 GMT</pubDate></item><item><title>Conductivity Meter Calibration: Procedure &amp; Acceptance</title><link>https://www.pharmaceuticalguideline.com/post/guidelines-for-calibration-of-conductivity-meter/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/guidelines-for-calibration-of-conductivity-meter/</guid><description>Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present.</description><pubDate>Sat, 16 Jul 2022 16:31:00 GMT</pubDate></item><item><title>SOPs in Pharmaceuticals: Format, Structure &amp; Writing Guide</title><link>https://www.pharmaceuticalguideline.com/post/standard-operating-procedures-sop/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/standard-operating-procedures-sop/</guid><description>Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the \&quot;standard\&quot; approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule</description><pubDate>Fri, 15 Jul 2022 17:45:01 GMT</pubDate></item><item><title>Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products</title><link>https://www.pharmaceuticalguideline.com/post/instructions-for-use-patient-labeling-for-human-prescription-drug-and-biological-products/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/instructions-for-use-patient-labeling-for-human-prescription-drug-and-biological-products/</guid><description>Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format…</description><pubDate>Thu, 14 Jul 2022 18:30:00 GMT</pubDate></item><item><title>GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS</title><link>https://www.pharmaceuticalguideline.com/post/guide-to-good-manufacturing-practice-for-medicinal-products/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/guide-to-good-manufacturing-practice-for-medicinal-products/</guid><description>News &amp; UpdatesPIC/S [PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME] has revised guideline No. PE 009-16 [GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS] on 1 February 2022.Key Revision: • Revision of Annex 13 • Annex 13 (Manufacture of investigational medicinal products) • New Annex added • Annex 16 (Authorised person and batch release)Click Here to Download the Guideline Our Dynamic Pharma Team is providing a step-by-step learning topic on this website.You will find Short No</description><pubDate>Mon, 31 Jan 2022 18:30:00 GMT</pubDate></item><item><title>Granules Dosage Form: Definition, Types &amp; Advantages</title><link>https://www.pharmaceuticalguideline.com/post/granules/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/granules/</guid><description>Granules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur</description><pubDate>Mon, 27 Sep 2021 17:08:25 GMT</pubDate></item><item><title>Good Chromatography Practices</title><link>https://www.pharmaceuticalguideline.com/post/good-chromatography-practices/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/good-chromatography-practices/</guid><description>Good Chromatography Practices for the pharmaceutical industry</description><pubDate>Tue, 20 Jul 2021 16:29:38 GMT</pubDate></item><item><title>Personal Hygiene in Pharmaceuticals: GMP Requirements</title><link>https://www.pharmaceuticalguideline.com/post/personal-hygiene/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/personal-hygiene/</guid><description>Personal hygiene requirements in the pharmaceutical industry</description><pubDate>Sat, 10 Jul 2021 17:31:32 GMT</pubDate></item><item><title>Films PHARMACEUTICAL DOSAGE FORMS</title><link>https://www.pharmaceuticalguideline.com/post/films-pharmaceutical-dosage-forms/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/films-pharmaceutical-dosage-forms/</guid><description>USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS</description><pubDate>Wed, 26 May 2021 16:37:16 GMT</pubDate></item><item><title>Capsules PHARMACEUTICAL DOSAGE FORMS</title><link>https://www.pharmaceuticalguideline.com/post/capsules-pharmaceutical-dosage-forms/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/capsules-pharmaceutical-dosage-forms/</guid><description>Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter &lt;1151&gt;</description><pubDate>Sun, 23 May 2021 15:19:38 GMT</pubDate></item><item><title>Aerosol Dosage Forms: Types, Formulation &amp; Examples</title><link>https://www.pharmaceuticalguideline.com/post/aerosols-pharmaceutical-dosage-forms/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/aerosols-pharmaceutical-dosage-forms/</guid><description>Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43</description><pubDate>Sat, 22 May 2021 15:59:16 GMT</pubDate></item><item><title>Pharmaceutical Dosage Forms: Complete Classification List</title><link>https://www.pharmaceuticalguideline.com/post/pharmaceutical-dosage-forms/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/pharmaceutical-dosage-forms/</guid><description>〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.</description><pubDate>Wed, 31 Mar 2021 16:04:41 GMT</pubDate></item><item><title>Good manufacturing practices for medical gases</title><link>https://www.pharmaceuticalguideline.com/post/good-manufacturing-practices-for-medical-gases/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/good-manufacturing-practices-for-medical-gases/</guid><description>Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.</description><pubDate>Sat, 20 Feb 2021 17:09:23 GMT</pubDate></item><item><title>Parenteral Dosage Forms: Types, Requirements &amp; Examples</title><link>https://www.pharmaceuticalguideline.com/post/parenterals/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/parenterals/</guid><description>INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…</description><pubDate>Wed, 17 Feb 2021 17:50:44 GMT</pubDate></item><item><title>INSPECTION OF UTILITIES</title><link>https://www.pharmaceuticalguideline.com/post/inspection-of-utilities/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/inspection-of-utilities/</guid><description>Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021</description><pubDate>Sun, 31 Jan 2021 17:58:43 GMT</pubDate></item><item><title>GMP INSPECTION RELATED TO PACKAGING</title><link>https://www.pharmaceuticalguideline.com/post/gmp-inspection-related-to-packaging/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/gmp-inspection-related-to-packaging/</guid><description>Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021</description><pubDate>Sat, 30 Jan 2021 17:20:13 GMT</pubDate></item><item><title>QRM Implementation: PIC/S Aide-Mémoire &amp; Assessment Guide</title><link>https://www.pharmaceuticalguideline.com/post/aide-memoire-on-assessment-of-qrm-implementation/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/aide-memoire-on-assessment-of-qrm-implementation/</guid><description>Pharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…</description><pubDate>Tue, 26 Jan 2021 18:36:00 GMT</pubDate></item><item><title>Site Master File (SMF): WHO Format, Contents &amp; Example</title><link>https://www.pharmaceuticalguideline.com/post/site-master-file/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/site-master-file/</guid><description>In this article, we will discuss a practical approach to prepare the Site Master File (SMF) for the Pharmaceutical Industry. We have to understand that The SMF is the document which explains your organization; it creates the image of the organization, So it should be self-explanatory as in most of the case you are not present to explain the SMF.Do you believe that the SMF is creating the first impression of your organization before visiting your Site…After discussing with various regulatory auth</description><pubDate>Thu, 14 Jan 2021 18:30:00 GMT</pubDate></item><item><title>Happy New year 2021</title><link>https://www.pharmaceuticalguideline.com/post/happy-new-year-2021/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/happy-new-year-2021/</guid><description>Pharmaceutical Guideline Wishing Happy New year to you and your family</description><pubDate>Fri, 01 Jan 2021 08:00:50 GMT</pubDate></item><item><title>Pharmaceutical Documentation: Hierarchy, Types &amp; GMP Rules</title><link>https://www.pharmaceuticalguideline.com/post/documentation/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/documentation/</guid><description>You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.</description><pubDate>Wed, 23 Dec 2020 18:30:00 GMT</pubDate></item><item><title>Departments in the Pharmaceutical Industry: List &amp; Roles</title><link>https://www.pharmaceuticalguideline.com/post/departments-in-the-pharmaceutical-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/departments-in-the-pharmaceutical-industry/</guid><description>Basic Work functions of the key Departments in the Pharmaceutical Industry</description><pubDate>Tue, 08 Dec 2020 08:51:00 GMT</pubDate></item><item><title>Quality Policy for Pharmaceutical Industry</title><link>https://www.pharmaceuticalguideline.com/post/quality-policy/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/quality-policy/</guid><description>In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…</description><pubDate>Mon, 30 Nov 2020 17:57:16 GMT</pubDate></item><item><title>JOB in Pharma</title><link>https://www.pharmaceuticalguideline.com/post/introduction-the-pharmaceutical-industry/</link><guid isPermaLink="true">https://www.pharmaceuticalguideline.com/post/introduction-the-pharmaceutical-industry/</guid><description>Pharmaceutical Industry contributes to improving the health and wellbeing of society.</description><pubDate>Thu, 26 Nov 2020 16:59:48 GMT</pubDate></item></channel></rss>