Good Manufacturing Practices
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Outward Material Storage Area and Dispensing Activity for Packaging Material Area
Abstract: Efficient management of outward material storage and packaging material dispensing is essential for maintaining product quality, regulatory compliance, and streamlined operations in manufacturing industries. This review examines the principles, practices, and challenges associated with the design, organization, and control of outward material storage areas, with a specific focus on packaging material handling. Key aspects discussed include layout optimization, material segregation, environmental controls, documentation practices, and adherence to Good Manufacturing Practices …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 1, 2026 · pp. 27–32 Read article
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Revamping of Pharmaceutical Manufacturing Processes
Abstract: The pharmaceutical sector is entering a new era marked by technological advancements and an emphasis on sustainability and efficiency. A commitment to compliance can help boost consumer confidence and regulatory approval. This abstract explores the multifaceted approach to revamping pharmaceutical manufacturing processes, encompassing technological integration, regulatory compliance, and sustainability initiatives. Technological advancements, including automation, data analytics, and artificial intelligence, are playing a pivotal role in streamlining manufacturing operations. These innovations …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 38–44 Read article