To ensure consistency and uniformity in the inspection process, the Central Drugs Standard Control Organisation (CDSCO) has issued the checklist of 'Risk Based Inspection of the Pharma Manufacturing Facilities' for verification of GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945.
This checklist would be used by drug regulatory enforcement agencies as a science based tool. It is also envisaged that pharma industry would also find this checklist useful for self-assessment. CDSCO has started imparting training to drug regulators and analysts from state and central governments for inspection of manufacturing units with respect to GMP and GLP based on the components of this document.
This proactive of the CDSCO is significant as safety, quality and effectiveness of products and services are of paramount importance for any drug regulator. The drug regulatory system needs to be transparent, time bound and ready to facilitate the industry to produce quality medical products. The role and responsibilities of the drug regulators have changed due to expansion and advent in pharmaceutical sciences. Now, their role is not limited only to issue permissions/licenses but to take a proactive role in ease of doing business in India.
The CDSCO has sought suggestions from all stakeholders on this document for further improvement of this checklist.
Some of the specifications mentioned in the checklist include Specify whether the whole facility is separated, dedicated and is not a part of any other non-drug facility; Specify whether the surroundings of manufacturing area is clean and as per the SOP prescribed in this regard. (Mention the SOP nos.); Describe the pest, insects, birds and rodents control system followed in the premises. Specify pest control schedule- area wise, along with materials and methods used; and Specify the lux level maintained in various parts of the premise (Storage area, manufacturing area specially visual inspection, Laboratory areas etc).