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Last updated: 2 October 2026
Good Manufacturing Practice (GMP) is the baseline for making medicines, cosmetics, food supplements and other regulated products safely. Expertvuw’s team runs gap assessments against Revised Schedule M and WHO-GMP, prepares documentation and gets your site ready for inspection.
GMP is a set of requirements ensuring that products are consistently produced and controlled to quality standards. It covers premises, equipment, personnel, hygiene, documentation, production, quality control, validation, complaints and recalls.
For pharmaceutical manufacturers in India, GMP is a legal requirement under Schedule M of the Drugs Rules, 1945. The Revised Schedule M, notified in December 2023, brought Indian requirements closer to WHO-GMP and PIC/S standards, adding a pharmaceutical quality system, quality risk management, product quality review and stronger validation. Larger manufacturers had to comply first, and MSMEs were given extended timelines.
GMP compliance is verified by drug regulators through inspections. Exporters may also need a WHO-GMP certificate or Certificate of Pharmaceutical Product (COPP), granted after inspection by CDSCO and state authorities.
Basis: Drugs and Cosmetics Act, 1940; Drugs Rules, 1945 – Revised Schedule M (notified December 2023); WHO GMP guidelines; CDSCO guidance on WHO-GMP/COPP. Last updated: 27 September 2026.
GMP is mandatory for drug manufacturers under Schedule M.
Notified in December 2023, aligned more closely with WHO-GMP and PIC/S.
Requires a pharmaceutical quality system and quality risk management.
Compliance is verified through regulator inspections.
WHO-GMP certificates and COPP are needed for many export markets.
GMP principles also apply to cosmetics, food supplements and medical devices under their rules.
Inspection findings often repeat across sites.
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GMP connects with these services.
Licences for drugs, devices and cosmetics.
State drug licences.
Quality management system.
Food safety hazard control.
Assess against Revised Schedule M or WHO-GMP.
Prioritise gaps with timelines.
Prepare SOPs and quality system documents.
Support validation and qualification work.
Run a mock inspection.
Support during regulator inspection.
GMP is maintained through daily practice.
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Share your query and our team will reply during business hours.
The updated GMP requirements for pharmaceutical manufacturers under the Drugs Rules, 1945, notified in December 2023.
GMP compliance is mandatory for drug manufacturers. WHO-GMP certification is often needed for exports.
Regulatory authorities (CDSCO with state drug controllers) after inspection.
No. Expertvuw prepares you for inspection; certificates are issued by the regulator or an accredited body.
Yes. Similar good manufacturing principles apply under their own rules and standards.
ACS – Director, Expertvuw Management Pvt Ltd
GMP readiness work is handled by Expertvuw’s team. GMP compliance is assessed and certificates are issued by the drug regulator or independent accredited bodies after their own inspection.