Pharmaceutical GuidelineLearning is lifeEmpowering Excellence in Pharmaceutical Manufacturing
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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.
Improving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry
The use of statistical tools plays a crucial role in ensuring the quality and efficacy of pharmaceutical products.
The 5 WHY analysis stands out as a highly efficient tool for root cause analysis
drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing.
Photostability Testing of New Drug Substances and Products in pharmaceutical industry
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…
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
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”.
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
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 or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
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 is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
is Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L & allow rapid delivery of their content
BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Sterile Water for Injection is water for Injection packaged and rendered sterile.
Sterile Purified Water is Purified Water, packaged and rendered sterile.
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
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
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
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] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
What is Difference between Quality Control and Quality Assurance?
Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ
VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.
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
News & 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
Personal hygiene requirements in the pharmaceutical industry
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…
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
You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.
In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
