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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.
5 Whys analysis is an essential tool for identifying the root causes of issues in the pharmaceutical industry
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
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
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.
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
Good Chromatography Practices for the pharmaceutical industry
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…
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…
Pharmaceutical Industry contributes to improving the health and wellbeing of society.
