The way of management is different in different places, I have operated in Zhejiang, Shanghai, Jiangsu, Anhui are different. For example, Zhejiang and Anhui only need a system framework, the system can be complete. But in Jiangsu, there is no requirement on the document to prepare a complete 0287 system, but most of the production license on-site inspection has been in accordance with the system of the physical examination process, the same check, the requirements of three batches of trial production, to retain all the system (production, testing, process control, etc., etc.) records, a lot of content. Shanghai is not the same, and even in the case of a license to do product type testing, on-site inspection directly renamed as the system assessment, that is, instead of the subsequent registration process of the system assessment, more standardized.
According to some peer meetings or other ways of communication and know that the rest of the domestic production license on-site inspection is basically relatively simple, as long as you do a system framework can be. LZ mentioned in the text of the quality manual, procedural documents, these are needed, in addition, you also need to prepare for the third level of documents, such as operating instructions (some call "WI" or "SOP"), and the corresponding forms and other documents.
In addition, there are three levels of documentation, such as operating instructions (WI or SOP) and corresponding forms.
In addition, depending on the product, the preparation of documents is different, such as aseptic products have to do a lot of extra work, which is the legendary "GMP", medical device circles in the formal abbreviation for "norms".
LZ if there are still related issues in the future, feel free to exchange.
Weekend break time rare pure hand-typed, hope to give points. Have a good weekend!