Navigating the Evolving Pharmaceutical Manufacturing Landscape in 2026
Sterile lab with shiny metal machinery, blue lighting, control panels, and empty glass vials on a conveyor. Modern and clean
GMP
33 articles tagged “GMP”
Deadline Dilemma: The Case for Extending Revised Schedule M to December 2026
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.
Enhancing Productivity and Quality in Pharmaceutical Industries
Improving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
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
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
Major Equipment of Tablets and Capsules Manufacturing
List of Major Equipment of Tablets and Capsules Manufacturing
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.
Conductivity Meter Calibration: Procedure & Acceptance
Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present.
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
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
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
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.
Departments in the Pharmaceutical Industry: List & Roles
Basic Work functions of the key Departments in the Pharmaceutical Industry
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.