Good Manufacturing Practice (GMP) compliance is not optional for pharmaceutical manufacturers in India — it is a legal and export requirement. This guide covers the key GMP standards that apply to your machinery.
Regulatory Framework
India's pharmaceutical GMP requirements are governed by Schedule M of the Drugs and Cosmetics Act, 1940. Exporters also need to comply with WHO-cGMP (Technical Report 902) and, increasingly, EU GMP or PIC/S standards.
Key GMP Requirements for Machinery
Material of Construction
Design for Cleanability
Validation
All GentlemanPharmed machines come with IQ/OQ/PQ protocol templates.
Documentation
GMP requires complete documentation for every machine:
CDSCO Inspection Readiness
During CDSCO inspections, inspectors will review:
1. Equipment qualification records
2. Preventive maintenance schedules and logs
3. Calibration certificates with traceability
4. Cleaning validation data
Ensuring your machinery supplier provides complete documentation is essential for passing inspections without deficiencies.
Contact GentlemanPharmed for GMP-compliant machinery with full validation documentation support.