*New draft available for comment: Changes to align GMP Annex to ISO 9001:2015 with Chinese GMP for excipients
China is one of a small number of countries which has legally defined GMP for excipients. Although the China excipients GMP is aligned with the IPEC-PQG GMP Guide 2006, and therefore EXCiPACT GMP, there are important differences and several increased requirements. Compliance to these regulations is compulsory for all excipients used in China, according to <Announcement of the National Medical Products Administration on Further Improving the Bundling Review and Approval with Drug Product and its Related Supervision Matters> (No.56, 2019). Chapter 21 confirms the excipient must be manufactured in accordance with the Chinese excipient GMP <Good Manufacturing Practice for Pharmaceutical Excipients> ( No. 120 issued by the SFDA).
A new section to the EXCiPACT GMP Annex has been drafted to cover those requirements of Chinese excipients GMP not explicitly included in the existing EXCIPACT GMP Annex. All existing parts of the EXCiPACT GMP Annex are included along with highlighted sections which show the additional requirements.
This new EXCiPACT annex, intended for China only, will replace the existing EXCiPACT GMP Annex for excipients to be used in drug products which are to be used in China.
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