(6th August, 2014); Central Drugs Standard Control Organization (CDSCO) ensuring uniform procedures in regulatory inspection for issuance of Certificates of Pharmaceutical Products (COPP) and other Good Manufacturing Practices (GMP) inspections. These procedures were discussed in 47th Drugs consultative committee (DCC) meeting.
Main focus of all GMP and COPP inspections will be on requirements of Schedule M of Drugs and Cosmetic Rules 1945 with respect to establishing shelf life, conducting validation studies and ensuring prompt and effective recall besides WHO GMP requirements.
Inspections are conducted for 2-5 days depending on the size of the manufacturing unit, the number of products handled, complexity of products and procedures. Inspection team shall prepare inspection plan, conduct opening meeting and exit meeting on the final day to summarize and discuss the observations with the manufacturers.
And immediate regulatory action will be implemented if any critical observations appeared regarding quality, safety and efficacy of the products. Final report of inspection may be finalized within one week, critically reviewed by Zonal officers and forwarded to state licensing authority for necessary action along with copy to CDSCO and manufacturers for compliance.
The State Drugs Control Authorities shall also initiate the process to qualify- inspectors for inspection of vaccines and pharmaceutical manufacturing facilities based on experience and training and ensure that each inspector carries out minimum five GMP inspections in one year to sustain the performance
The inspections of medicines and biologicals should be conducted using risk-based approach and should specifically focus on product development, product quality attributes, stability study conducted to establish shelf life in Indian climatic conditions, process validation, complaint/recalls, handling of out of specification, deviations, change control procedures, aseptic processing, sterilization etc.
