Biopharmaceutical laboratories usually consist of two parts: physical and chemical laboratories and microbiological laboratories. Physical and chemical laboratories use physical and chemical methods to identify raw materials, packaging materials, intermediates and finished products for production, content determination and other analysis and inspection. Microbial laboratories generally have the following functions: verification of microbial test methods, sterility test, microbial limit test, microbial test of antibiotic titer, determination of penicillinase and its activity according to the requirements of Chinese Pharmacopoeia. According to the requirements of the current "Standards for the Quality Control of Pharmaceutical Production", the cleanliness of clean rooms in pharmaceutical industry is determined by microorganisms.
报错
1. In the design of microbiological laboratory, we should understand the inspection process, process nature, relevant standards and norms, and arrange the corresponding microbiological inspection function room according to the production variety and inspection workload of pharmaceutical manufacturers.
2. Quality control laboratories should usually be separated from production areas. Laboratories for biological verification, microorganisms and radioisotopes should also be separated from each other.
3. The design of the laboratory should ensure that it is suitable for the intended use and can avoid confusion and cross-contamination. There should be sufficient areas for sample disposal, sample retention and stability inspection, sample storage and record preservation.
实验室选址- Planning and design
Engineering services- System establishment
Qualification obtaining
