Tag: In-process controls

Validation Unveiled: A Comprehensive Insight with Reference to Schedule M When it comes to ensuring the quality, safety, and efficacy of pharmaceutical products, there’s no room for uncertainty. Validation, a cornerstone of Good Manufacturing Practices (GMP) within the pharmaceutical industry, plays a pivotal role in guaranteeing that every step of the manufacturing process meets the…

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Deciphering Stability Studies in the Framework of Schedule M: Ensuring Longevity and Quality of Pharmaceuticals When we look beyond the pill or vial and delve into the intricate world of pharmaceutical manufacturing, we encounter a vital element that determines a product’s integrity and efficacy over time – stability studies. In the context of Schedule M,…

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Schedule M: Ensuring Quality in Pharmaceutical Manufacturing As we delve into the intricate realm of pharmaceutical manufacturing, we encounter a regulatory framework that serves as the backbone of our operations – Schedule M of the Indian Drugs and Cosmetics Act. This comprehensive set of guidelines lays the foundation for ensuring the safety, efficacy, and quality…

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Comparative Table: Schedule M v/s WHO GMP Aspect Schedule M WHO GMP Application Specific to Indian pharmaceutical industry International guidelines for pharmaceutical manufacturing Scope Regulatory framework for pharmaceutical manufacturing in India Global standards for pharmaceutical manufacturing Quality Control Emphasizes quality control measures and testing procedures Focuses on quality assurance, including quality control and risk management…

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