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Pharmaceutical exports to regulated markets such as the US, EU, and Canada require adherence to stringent quality standards. One of the key regulations governing pharmaceutical manufacturing in India is Schedule M under the Drugs and Cosmetics Act. Compliance with Schedule M ensures that manufacturers meet Good Manufacturing Practices (GMP), making their products acceptable in global markets. This blog explores the significance of Schedule M compliance, its requirements, and its impact on exports.
Understanding Schedule M
Schedule M lays down the guidelines for Good Manufacturing Practices (GMP) for pharmaceuticals in India. It covers various aspects of production, quality control, premises, equipment, and documentation to ensure drug safety and efficacy.
Why Is Schedule M Compliance Important for Exporting?
Key Requirements of Schedule M Compliance
FAQs
Yes, Schedule M compliance is mandatory for all pharmaceutical manufacturers in India to ensure adherence to GMP standards.
It enhances product quality, facilitates regulatory approvals, and improves global market acceptance.
Non-compliance can lead to regulatory action, export restrictions, product recalls, and loss of reputation.
By upgrading manufacturing facilities, implementing stringent quality control measures, training staff, and maintaining proper documentation.
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