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发表于 2022-1-29 21:30:28
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Q&As: China GMP and Registration of APIs 05.01.2022
In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.
With regard to China GMP requirements, a set of the most important questions raised during the training and the respective answers provided by our speaker Mr Francois Vandeweyer, VDWcGMP Consulting, Belgium, are listed in the following. All answers reflect the opinion of the speaker based on his experience.
Question 1: Does China's Health Authority normally conduct inspections at API manufacturers in Europe?
Answer: China's Health Authority, the so called National Medical Products Administration (NMPA), has initiated overseas inspections about four to five years ago. They performed these inspections risk based giving highest priority to sterile Active Pharmaceutical Ingredients (APIs), aseptic sterile APIs and low bioburden APIs (used in injections). Non sterile APIs were not excluded but only rarely inspected.
Since the Covid-19 pandemic, these overseas inspection visits have been stopped. But the program will be continued in the future.
Question 2: What's different to the EU GMP requirements/guidelines? Could you please provide three examples?
Answer:
The main difference is in fact that final API manufacturing steps (from final crystallization and steps afterwards including milling/sieving) are part of the Drug Product (DP) guidelines and not API guidelines. This means that also for non-sterile APIs Grade D environmental controls and conditions are required.
The qualification requirements for the head of production management are as follows: College degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist's license),
with at least three years of practical experience in pharmaceutical production and quality management, among which at least one year in production management, with necessary training relating to the products being manufactured.
The qualification requirements for the head of quality management are as follows: College degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist's license), with at least five years of practical experience in pharmaceutical production and quality management, among which at least one year in quality management, with necessary training relating to the products being manufactured.
Testing is required according to Chinese Pharmacopeia. As an example, water for pharmaceutical use should be suitable for its intended use, and meet the specifications of the Chinese Pharmacopeia and the related requirements.
Question 3: Do the Chinese GMP requirements also apply to APIs manufactured in Europe and used in a drug product manufactured in Europe and then imported to China?
Answer: Yes! Remember the final manufacturing steps of API manufacturing are part of the China's Drug Product guidelines! So the same requirements are expected for the final APIs steps and DP manufactured in the EU, before these are placed on the Chinese market.
For intermediates in API manufacturing Chinese GMP is following the ICH Q7 guideline.
Question 4: Is there a specific API labelling needed?
Answer: No, the labelling requirements are the same as specified in ICH Q7.
Question 5: Is it required to provide audit reports for Regulatory Starting Material (RSM) suppliers?
Answer: No, audit reports of RSM suppliers for API manufacturing do not need to be provided to the NMPA with the regulatory filing.
For EU and FDA, if the Health Authorities request the audit report of a RSM you need to share the reports during the on-site inspection.
For China, I would handle this the same way. Share on-site during the inspection.
For customers, it is the company's decision, if they want to share the RSM audit report during on-site inspections or not.
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