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background
backgroundOn May 10, 2021, the National Medical Products Administration issued on its official website the "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Supervision (Guobanfa [2021] No.
text
text01 personnel management
The laboratory needs qualified inspectors to ensure the accuracy of the test results.
02Equipment Management
Especially the management and operation of high-precision instruments.
They also did not consciously check the original records of the atomic absorption spectrophotometer, let alone pay attention to the precision requirements of the atomic absorption spectrophotometer.
In addition, if you encounter an audit by an expert who understands verification and calibration, and randomly check two or three pieces of equipment, do your company's verification and verification meet the requirements? First of all, is there a one-to-one correspondence between the certificate and the instrument? Secondly, are the certificates within the validity period? Third, the results of the verification or calibration certificate have been confirmed and meet the requirements of the inspection process?
03Material Management
Laboratory materials are roughly divided into samples and medicines.
If your laboratory encounters inspection and testing experts to audit, will it be able to handle it? For samples, are there relevant document requirements for sampling, sample separation, sample preparation, sample testing, waste disposal, and retention of samples? Have the inspection personnel been trained for these requirements and passed the evaluation? The operation of the inspection personnel is carried out in accordance with the requirements of the documents? If a certain sample or a certain kind of medicine is randomly checked.
04Environmental Management
The laboratory has relatively high environmental requirements.
05Inspection
Especially in terms of microbial detection.
06 method management
Has your laboratory established its own testing methods, especially when there are no national, industry, and local standards.
In addition, OOS/OOE/OOT management.
to sum up
to sum upIf you want to audit the operation of a company, go to audit the company's finance department.
Of course, if your laboratory is tall enough, or the laboratory does a good job, it will not tremble because of inspections.
