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
Manufacturing
14 articles tagged “Manufacturing”
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
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…
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Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products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
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
CREAMS
Creams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes
Sterile Water for Injection
Sterile Water for Injection is water for Injection packaged and rendered sterile.
Emulsions
An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents
Major Equipment of Tablets and Capsules Manufacturing
List of Major Equipment of Tablets and Capsules Manufacturing
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