24 articles
QAThe revised Schedule M is the standard your next inspection will be run against. Which Parts apply to your licence, what is built once for the whole site, what blocks what, and what an inspector asks for in the first four hours.
QAISO 9001:2026 is published and the transition runs to September 2029. What is genuinely new, what was already required before this edition, and what it means if you also work to GMP.
QAWhy retraining alone rarely works, and the practical controls that reduce human error in pharmaceutical manufacturing, packaging and documentation.
GeneralAs 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.
GeneralImproving productivity & quality is critical to ensuring efficient operations, regulatory compliance & the delivery of high-quality products
Manufacturing and PackagingDraft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
Manufacturing and PackagingPastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
Manufacturing and PackagingWHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
Manufacturing and PackagingLOTIONS Lotions are an emulsified liquid dosage form intended for external application to the skin. Historically, some topical suspensions such as
Manufacturing and PackagingCreams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes
Manufacturing and Packagingis Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L & allow rapid delivery of their content
Manufacturing and PackagingBWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Manufacturing and PackagingSterile Water for Injection is water for Injection packaged and rendered sterile.
Manufacturing and PackagingUS FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines
GeneralAn emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents
GeneralPurified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION
GeneralList of Major Equipment of Tablets and Capsules Manufacturing
Manufacturing and PackagingNews & 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
GeneralGranules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur
Manufacturing and PackagingUSP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Manufacturing and PackagingAerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
General〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Manufacturing and PackagingWorking document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
Manufacturing and PackagingCo-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
