Enhancing Productivity and Quality in Pharmaceutical Industries
Improving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
Quality Assurance
62 articles tagged “Quality Assurance”
How to Utilize 5 WHY Analysis to Uncover Root Cause
5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry
5WHY Analysis for Pharmaceutical: Uncovering Root Causes Effectively
The 5 WHY analysis stands out as a highly efficient tool for root cause analysis
Photostability Testing of New Drug Substances
drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
Photostability Testing of New Drug Substances and Products
Photostability Testing of New Drug Substances and Products in pharmaceutical industry
Changes in 21 CFR Part 11 Subpart C, Electronic Signatures
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…
Shutdown of European Pharmacopoeia 10th Edition
European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
ICH Q9(R1) Quality Risk Management: Summary & Changes
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
FDA Dosage & Administration Labeling Guidance — Docket No.
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
New paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines
WHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
Signal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques
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”.
Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders
IMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
OTHER NONMONOGRAPHED WATERS
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
WATER FOR BACTERIAL ENDOTOXINS TEST
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
Pharmaceutical Dosage Form - Gums
Medicated gum is a pliable dosage form that is designed to be chewed rather than swallowed. it Release the drug substances into the saliva.
DEAERATED WATER
Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
HIGH-PURITY WATER
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
FILTERED WATER
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
DEIONIZED DISTILLED WATER
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
DEIONIZED WATER
Deionized Water is produced by an ion-exchange process in which the cations & anions are replaced with H+ & OH− ions by use of ion-exchange
DISTILLED WATER
Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
DRINKING WATER
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
SOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
Nonmonographed Waters
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
STERILE WATER FOR IRRIGATION
is Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L & allow rapid delivery of their content
BACTERIOSTATIC WATER FOR INJECTION
BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Sterile Water for Injection
Sterile Water for Injection is water for Injection packaged and rendered sterile.
STERILE PURIFIED WATER
Sterile Purified Water is Purified Water, packaged and rendered sterile.
Size, Shape, and other physical Attributes of Generic Tablets and capsules
US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines
Emulsions
An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents
Water for Hemodialysis
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
Water for Injection
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
Purified Water [PW]
PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Performance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
Operational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
Installation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
Site Acceptance Test [SAT]
Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
What is Difference between Quality Control and Quality Assurance?
What is Difference between Quality Control and Quality Assurance?
Design Qualification [DQ]
Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
User Requirement Specification (URS) in Pharma + Template
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility] in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ
VALIDATION MASTER PLAN (VMP)
VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.
SOPs in Pharmaceuticals: Format, Structure & Writing Guide
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 \"standard\" 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
Granules Dosage Form: Definition, Types & Advantages
Granules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur
Good Chromatography Practices
Good Chromatography Practices for the pharmaceutical industry
Personal Hygiene in Pharmaceuticals: GMP Requirements
Personal hygiene requirements in the pharmaceutical industry
Films PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosol Dosage Forms: Types, Formulation & Examples
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Pharmaceutical Dosage Forms: Complete Classification List
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Good manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
Parenteral Dosage Forms: Types, Requirements & Examples
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…
INSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
GMP INSPECTION RELATED TO PACKAGING
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
QRM Implementation: PIC/S Aide-Mémoire & Assessment Guide
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…
Site Master File (SMF): WHO Format, Contents & Example
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
Pharmaceutical Documentation: Hierarchy, Types & GMP Rules
You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.
Quality Policy for Pharmaceutical Industry
In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
JOB in Pharma
Pharmaceutical Industry contributes to improving the health and wellbeing of society.