Shake it, pharmaceutical manufacturer!

background

On 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.
16)".
There is a sentence in the opinion: "Encourage the city and county personnel engaged in drug inspection and testing to obtain the qualification of drug inspector and participate in the work of drug inspection.
" With such a seemingly simple sentence, it can be said that an atomic bomb was dropped at a pharmaceutical manufacturer.
In the past, drug inspectors focused on the inspection of the production process and regulatory documents, and seldom checked the laboratories of drug manufacturers.
Even if there is an inspection of the laboratory, because the laboratory work is relatively professional, most of the laboratories are watching the flowers.
After visiting them, they found some trivial problems.
If the personnel engaged in drug inspection and testing are enriched in the team of drug inspectors and inspect the laboratory, the inspection will be overwhelming.
If there are any problems in the inspection of a pharmaceutical manufacturer, then the same problems will be found in its laboratory.
This is because the laboratory is a highly equipped organization.
All aspects involved in an organization (drug manufacturing company) will be included in the laboratory test.
The laboratories will have people, machines, materials, methods, loops and tests.
Compared with the production department, except for the management personnel, the laboratory personnel are all technical jobs and belong to the high-tech department.

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01 personnel management

The laboratory needs qualified inspectors to ensure the accuracy of the test results.
The training and evaluation of inspectors is an important part of laboratory management.
First of all, inspectors must be certified to work.
Secondly, inspectors must undergo relevant professional knowledge training, and pass assessment and evaluation before they can operate independently.
Third, inspectors who can operate independently should be retrained, re-assessed and evaluated according to the planned frequency.
Finally, the inspectors must implement dynamic management, and the inspectors who meet the requirements but do not meet the requirements must be transferred from the inspection positions in time.
Certain groups of people cannot meet the requirements for certain specific testing items.
For example, with regard to impurity testing, older inspectors will be less sensitive to it.
For the same reason, odor detection, cold people cannot carry out their work well and need to be transferred.

02Equipment 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.
Only a university professor invited by a client asked the laboratory technician to turn on the computer and view the original map.
Other auditors, whether they are governments, customers, or certification agencies, when they see the atomic absorption spectrophotometer, they talk about its loftiness, and no one seriously examines the relevant original records.
Even the most powerful group, the world's largest customer, every time it audits, it is bullish, what is wrong here is wrong.
When they arrive in the laboratory, they will be much more low-key.

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.
I am fully aware of the mystery.
Of course, there are many high-precision instruments in large pharmaceutical companies, and if you don’t know how to audit by prosecutors, you can only go through the process.
If you encounter real experts, I am afraid that many companies will shake.

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.
For samples, its management involves sampling, sampling, sample preparation, sample testing, waste disposal after testing, and sample retention management.
Especially the samples involved in the stability investigation are the focus and difficulty of sample management.
For laboratory drugs, its management mainly involves requisitions, purchases, inspections, storage, delivery, preparation, use, waste disposal, and related records.

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.
Can your company match the accounts, things and cards; the identification is clear, complete and accurate?

04Environmental Management

The laboratory has relatively high environmental requirements.
Generally, temperature and humidity are required.
Specific testing items will have special requirements.
For example, some testing items will require a water bath, and the water bath has temperature and accuracy requirements, which need to be controlled by related control methods.
For example, in the cultivation of microorganisms, the temperature and time of cultivation of different microorganisms will be different.
For example, the precision instrument room will also have its specific requirements, in addition to temperature and humidity requirements, but also anti-corrosion requirements.

05Inspection

Especially in terms of microbial detection.
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.
No one has ever audited the operation of microbiological testing.
If one day one of the drug inspectors your company receives is a microbiology expert, it must go from sampling, sample separation, medium preparation, sterilization, microbiological inspection operations to cultivation, inspection result statistics, inspection waste disposal, and inspection results.
The report and the whole process are audited, so will your company's quality manager, laboratory manager and microbiological laboratory manager tremble? If there is a pathogen test, especially when the pathogen test is positive, will the microbiological test operators, the person in charge of the microbiological laboratory, the person in charge of the laboratory, the person in charge of quality and the person in charge of the enterprise panic?

06 method management

Has your laboratory established its own testing methods, especially when there are no national, industry, and local standards.
Has the company formulated corporate standards and established internal control testing methods based on corporate standards? Are the laboratory management documents consistent with the relevant national documents and company management documents, and there is no conflict? Are your laboratory documents well established and controlled? Are your laboratory documents suitable for laboratory use? Do the operators of your laboratory operate in accordance with the established document requirements? Does your company's laboratory test results meet the requirements of relevant standards? Does your company's laboratory test results meet the requirements of relevant 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 document is established, the laboratory technicians need to be trained, and only after the training is qualified, they are allowed to work, and the laboratory management is strengthened.
At the same time, do a good job in the laboratory to welcome the baptism of inspection and testing experts, and continuously improve the management of the laboratory.
(CPhI Pharmaceutical Online )