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Regulatory News | 26 May 2016 | By Zachary Brennan
India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India.
The checklist and tool will help CDSCO and state inspectors understand and collaborate on which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are compliant.
“The inspections are planned to be carried out jointly by the CDSCO officials and Drug Inspectors of the States concerned. The inspections will assess the compliance of manufacturing facilities with the specified GMP and GLP requirements and also seek to harmonize the procedures for conduct of inspections throughout the country, identify gaps in such compliance and communicate the same to the manufacturers for compliance,” CDSCO said in public notice.
CDSCO also said it will take suggestions and amend the checklist and tool after stakeholders weigh in.
As part of efforts to improve manufacturing quality on the subcontinent, the Indian regulator also initiated a week-long training program on the checklist and evaluation tool, as well as other related areas to ensure the inspections don’t cause “any undue harassment to the manufacturers or their employees and the inspections are carried out in an objective and transparent manner.”
The first of these training programs was conducted between 9 May and 14 May, and the second training program is currently in progress at the National Institute of Biologicals.
Among the items on the checklist are questions on the location and surroundings, building and premises, water and waste system and other pertinent details on warehousing, production, quality control and manufacturing operations and controls.
The notice comes as the US Food and Drug Administration has increasingly been citing Indian manufacturers for data integrity issues dating back to at least 2013, and most recently in April. In some of the most egregious cases, companies have overwritten data collected by software or deleted pertinent data.
Public Notice
GMP Checklist
Tags: Indian drug manufacturing, API manufacturing, data integrity