Good Manufacturing Practices (GMP) standards vary across countries. While the core principles of GMP—such as ensuring product quality, maintaining clean facilities, and proper documentation—are universally recognized, specific requirements, inspection procedures, and enforcement mechanisms can differ based on national laws and regional agreements. Each country’s regulatory authority defines and enforces these standards to ensure the safety, quality, and efficacy of pharmaceutical products. This site contains the blogposts which focuses on articles specific to GMP regulations in India, offering insights into the country’s pharmaceutical regulatory framework along with general articles related to the concept of Quality.
In India, the pharmaceutical regulations define what must be done but do not prescribe how to implement those requirements. The Implementation procedures are outlined in the guidance document issued by the Central Drugs Standard Control Organization (CDSCO). The absence of specific procedural mandates in the regulations encourages innovation and flexibility in compliance strategies.
This blog features various articles on Good Manufacturing Practices (GMP), Quality Management Systems (QMS), regulatory compliance, and scientific advancements relevant to the pharmaceutical industry. Stay updated with comprehensive, regulation-specific insights designed to support industry professionals navigating India’s complex regulatory environment. You can read my blog posts here
Disclaimer: This blog should not be viewed as the exact statement of law.