FDA Certification And GMP Implementation Problems For The Domestic Api Manufacturer And The Solutions Discussion

Compared with those big pharma companies from EU and US, for most of domestic ones, as a matter of fact, lots of improvements are needed to meet the cGMP requirement, the domestic pharm companies are not in better situation as they are lacking of good GMP implementation skills and sufficient experienced human resources, now cGMP compliance is the essential if we want to export the products to EU or US market.Based on the previous experience on DMF preparation and cGMP implementation, and on FDA basis, here the author did a deep analysis on the issues for DMF preparation and GMP compliance, then throw out the systematic solutions for these issues, time saving and cost reduction to the domestic pharma companies is the intention for this article.The 1st chapter is to introduce the FDA certification flow chart and the cost analysis for this event, and detailed description on DMF preparation, the difference among Chinese GMP, US GMP and ICH Q7a, also contributed lots of paragraphs to introduce the difference between Chinese old and new GMP as the new GMP effective on Mar. 01, 2011.The 2nd chapter, the author did the deeply analysis for the problems with the DMF preparation and GMP implementation.The 3rd chapter, the author identified the root causes for the problems raised in the 2nd chapter, and figured out the systematic solution from the aspects of process R&D, impurities profiling, engineering design, validation, documentation system set up and internal audit, as well as the cases study.The 4th chapter, i.e. the last chapter, the author summarized the article, listed out the highlights and those parts need to be further improved.