In order to verify GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945, Central Drugs Standard Control Organisation (CDSCO) has successfully concluded 185 risk based inspections in 8 phases based on a checklist issued for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country.

CDSCO checklist and evaluation is aimed at streamlining uniform inspection procedures across the country related to good manufacturing practices (GMP). The checklist and tool is meant to help CDSCO and state drug regulators understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. The inspections are planned and carried out jointly by the CDSCO officials and Drug Inspectors of the States concerned.

CDSCO has developed checklist and evaluation tool to outline proper inspection procedures with a consistent nationwide approach for the inspections to be carried out by CDSCO officials and state regulators.

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).

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.

This will be a big boost to several Indian drug makers which had come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.

The current upgradation of WHO-GMP norms is also being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices.

As per the WHO website, GMPs include factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personal hygiene.

Growing number of audits are going to be taken up by global agencies worldwide in future with global regulators hiring drug inspectors for auditing sites in respective countries of engagement and operations for GMP compliance.