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background
May 10, 2021, the State Drug Administration in its official website released a "State Council on the overall strengthening of the regulatory and Drug Opinions capacity building (Guo Ban Fa [2021] No.
16)"
.
There is an opinion "to encourage cities and counties to engage in drug inspection and other personnel access to medication inspector qualifications, participate in pharmaceutical inspection"
text
First, personnel management
.
The laboratory needs qualified inspectors to ensure the accuracy of the test results
Second, equipment management, especially the management and operation of high-precision instruments
.
I have received hundreds of large and small audits and audited atomic absorption spectrophotometry in the laboratory.
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
.
I have led the company's atomic absorption modification project, especially the verification and verification 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? Furthermore, the results of the verification or calibration certificate have been confirmed to meet the requirements of the inspection process?
Third, material management
.
Laboratory materials are roughly divided into samples and medicines
Fourth, environmental management
.
The laboratory has relatively high environmental requirements
Fifth, the detection aspect, especially the microbiological detection aspect
.
Because of the special nature of microbiological testing, in the audits I received, we can only look at the microbiological testing preparation room, testing equipment, documents and records
Sixth, method management
.
Has your laboratory established its own testing methods, especially when there are no national, industry, or local standards.
In addition, OOS/OOE/OOT management
.
Although everyone has been calling for OOS for many years, how is your company's OOS management? Can it withstand the audit of inspection experts? First of all, are your company’s OOS management files really used in laboratories? Secondly, does your laboratory really conduct OOS management in accordance with the established documents? Finally, does your company’s OOS account include all OOS? In short, whether your company's OOS can withstand the audit of expert-level inspectors
.
to sum up
If you want to audit the operation of a company, go to audit the company's finance department
.
If you want to really understand the quality control of a company, you should audit its laboratory
.
This is because the incoming inspection account of the laboratory can check all the quality information of the purchased and inspected materials in a comprehensive and detailed manner; the process console account can check the quality control points and control items in a comprehensive and detailed manner; the inspection table for intermediate products and finished products You can check the production status and inspection results of intermediate products and finished products in a comprehensive and detailed manner
.
For unqualified material inspections, unqualified process control inspections, unqualified inspections of intermediate products and finished products, the company's quality management personnel may adjust the relevant ledger, but the laboratory will not, because their workload is too much.
Follow the serial number
.
Even if the workload of the laboratory is not large, because the laboratory operators are only trained to be responsible for the results of the test items they are responsible for, unlike the quality management personnel who are responsible for the audit results as a whole, the laboratory records are basically true Data
.
Of course, if your laboratory is tall enough, or the laboratory does a good job, it will not tremble because of inspections
.
Otherwise, all shake
.
If your laboratory is not doing very well at present, it is recommended that from now on, the laboratory should be required to study relevant laws and regulations and establish documents in accordance with relevant requirements
.
After the documents are established, laboratory technicians need to be trained, and only after qualified training can they be allowed to work, and laboratory management shall be strengthened
.
At the same time, do a good job in the laboratory to welcome the baptism of inspection and testing experts, and continue to improve the management of the laboratory
.
About the author: Lao Chen, quality management expert, has been engaged in quality management and quality control related work in the food and pharmaceutical industries for nearly 20 years, and has served as QA supervisor, quality director, quality manager and production plant director
.
A well-known multinational gelatin company in China is responsible for quality and food safety management system management
.
