The report must include ① The organizational structure of drug production factories (workshops) (including the functions and interrelationships of various organizational departments);
② All dosage forms and varieties produced by pharmaceutical production factories (workshops);
③ Environmental conditions, storage, and general layout plan of pharmaceutical production factories (workshops);
④ Overview and process layout plan of the drug production workshop (including changing rooms, bathrooms, pedestrian and material passages, air locks, etc., and indicating the air cleanliness level);
⑤ Process flow diagram and main process control points of the produced dosage form or variety;
⑥ Each person selects a department, position, and responsible person to write down their responsibilities;
⑦ Understand the names of variousmanagement documents and SOPsof each department that pharmaceutical factories need to prepare to implement GMP certification in accordance with the detailed rules of the “Good Manufacturing Practice for Drugs”, and write a specific SOP;
⑧ Other GMP implementation methods and personal experiences,gains, and suggestions.
The report applicable to each factory should also include:
Other information related to pharmaceutical factory that can be learned, such as safety management, waste disposal, operational rules, new product research and development, etc
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