China sets out quality rules for pharma excipients
pharmafile | July 3, 2012 | News story | Manufacturing and Production | China, GMP, IPEC, manufacturing
China’s State Food & Drug Administration has published a draft regulation laying out a number of new measures for boosting oversight and controls on pharmaceutical excipients that are due to come into force on 1 October.
The new ‘Regulation on Strengthening Pharmaceutical Excipients Supervision’ document was officially unveiled earlier this month with a comment period of only a few days, and lays out a framework for the quality systems that should be employed by pharmaceutical manufacturers and excipient suppliers.
A major change is the introduction of explicit responsibility by companies for the quality of the excipients used in their products.
China is in the midst of a major reworking of the regulations covering the manufacturing of pharmaceuticals, introducing a drug master file for excipients in 2010 and bringing new Good Manufacturing Practice (GMP) legislation into practice in March 2011.
The updated GMP rules place greater emphasis on the use of effective quality control system by pharmaceutical companies, through the strengthening of drug manufacturing quality management systems, and the latest regulation on excipients is in keeping with that trend.
The regulation seeks to strengthen the monitoring of excipient manufacturers via mechanisms such as on-site audits and retrospective analyses of suppliers’ quality systems, and will require excipient manufacturers to conduct full testing of all batches made to ensure they conform to specifications.
Meanwhile, pharmaceutical manufacturers will be asked to record much more information on the excipients used in their drugs and their suppliers, and submit this information to the authorities.
The document refers to two categories of excipients – novel and high-risk excipients that require a drug manufacturing license, and other excipients which can be sold provided they have a Drug Master File. It also says that China plans to set up a database on manufacturing and use status of excipients ‘for government supervision’.
The IPEC Federation – an umbrella group representing manufacturers and users of pharmaceutical excipients – said it has reviewed the proposed regulation and provided comments to the SFDA.
Phil Taylor
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