The parts related to oral solids, oral liquids, topical preparations, active pharmaceutical ingredients and meter-dose inhalers are same in the proposed rules as present in the existing …

The licensee shall prevent mix-up and cross-contamination of drug material and drug product (from environmental dust) by proper air-handling system, pressure differential, segregation, …

Regular, periodic or rolling quality reviews of all pharmaceutical products should be conducted. Verify the consistency of product, process and quality parameters. The manufacturer should …

Feb 6, 2025 · We have described the specific requirements for manufacturing investigational pharmaceutical products for the purpose of clinical trials, as per the revised Schedule M.

Feb 12, 2025 · Compliance with Schedule M Revised aligns with international GMP standards, simplifying approvals from global regulatory authorities such as the US FDA, EMA, and WHO.

The recent amendment to the Drugs Rules, 1945, published on December 28, 2023, introduces significant updates under Schedule M, aimed at enhancing the Good Manufacturing Practices …

GMP (Good Manufacturing Practices) and Requirements of Premises, Plant and Equipment. In order to ensure production of quality drug formulation, it is necessary on the part of the …

Dec 3, 2024 · We've created concise notes from the revised schedule M for each point to guide manufacturers in maintaining GMP standards.

Dec 25, 2024 · This article explores how Schedule M (Revised) addresses the unique challenges in manufacturing biologics and biosimilars, ensuring compliance and patient safety.

Jun 28, 2024 · Explore the revolutionary changes brought by the Revised Schedule M in pharmaceutical marketing. Understand the new compliance standards and how they are …