DCGI issues uniform procedures in regulatory inspection for issuance of CoPP, GMP certificates Ramesh Shankar, Mumbai Monday, August 11, 2014, 08:00 Hrs [IST]

In order to ensure uniform implementation of regulatory inspection procedures for issuance of CoPP and other GMP certificates by both the state drug authorities and the CDSCO, the drugs controller general of India (DCGI) has issued new uniform procedures. As per the new procedures, all GMP inspections including that of CoPP will be focussing mainly on the requirements of Schedule M of Drugs and Cosmetics Rules, 1945 with respect to establishing shelf life, conducting validation studies, and ensuring prompt and effective recall besides WHO GMP requirement. According to the new directive, it has to be ensured that 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 summarise and discuss the observations with the manufacturers. In case of critical observations which have direct impact on the quality, safety and efficacy of the product and where regulatory action has to be initiated immediately, reports have to be finalised at the end of inspection without delay.  The final report of inspection may be finalised within one week, critically reviewed by zonal officers and forwarded to state licensing  authority for necessary action along with copy to CDSCO (HQ) and manufacturers for compliance, if any. As per the new procedures issued by the DCGI, the state drug 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 medicine 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, complaints/recalls, handling of out of specification, deviations, change control procedures, aseptic processing, sterilisation, etc.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83449&sid=1