How should the drug manufacturer on the docking list receive drug inspections?

To receive official inspections well, pharmaceutical manufacturers must understand the relevant requirements and contents of official inspections.

1.

Drug inspections are divided into licensing inspections, routine inspections, due-cause inspections, and other inspections.

(2) The inspection found

1.

If the suspected illegal act may have a drug quality and safety risk, the drug regulatory authority responsible for the supervision of the drug manufacturer shall order the drug manufacturer to take corresponding risk control measures.

If a drug manufacturer is found to be involved in a crime, the drug supervision and administration department responsible for the supervision of the drug manufacturer shall, in accordance with relevant regulations, transfer or notify the public security organ in a timely manner.

2.

If there is evidence that a drug manufacturer may have a potential safety hazard, the drug supervision and administration department shall, based on the supervision and inspection situation, take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import, and promptly announce the inspection and handling results.

3.

Defects are divided into serious defects, major defects and general defects, and their risk levels are sequentially reduced.

For inspections of pharmaceutical manufacturers, the risk level of defects is determined in accordance with the "Guidelines for Risk Assessment of Drug Production Site Inspection".

(3) On-site conclusion

On-site inspection conclusions and comprehensive assessment conclusions are divided into compliance with requirements, basic compliance with requirements, and non-compliance with requirements.

2.

When the official on-site inspection of drugs begins, the first meeting will be held.

(2) Accept inspection

During the inspection process, the pharmaceutical manufacturer shall provide relevant materials required for the inspection in a timely manner.
At the same time, when the relevant personnel of the pharmaceutical manufacturing company are answering the questions of the inspectors, they must ask the questions clearly before answering them to avoid misunderstandings.
If there is a misunderstanding, please promptly ask relevant personnel to explain clearly.

During the inspection process, if the inspection team needs to sample and submit for inspection of the products, intermediates, and original and auxiliary packages of the drug manufacturer, the drug manufacturer shall cooperate with the inspection team to sample and submit for inspection.

(3) Participate in the final meeting

After the on-site inspection, when the inspection team convenes the final meeting, the relevant personnel of the pharmaceutical manufacturer should actively participate.

If the inspection conclusion is in compliance with the requirements, this is the most happy thing for the inspection team and the drug manufacturer.
The reception staff of the pharmaceutical manufacturing enterprise shall sign and affix the company seal for confirmation.

If the inspection conclusion is basically in compliance with the requirements or not in compliance with the requirements, if the inspection conclusion of the drug manufacturer disagrees, a statement of defense may be made.

If suspected of violating the law or refusing or evading supervision and inspection, the pharmaceutical manufacturer shall actively cooperate with the inspection team.

3.
Follow-up work after inspection

(1) Suspected of illegal

If the suspected illegal act may have a risk of drug quality and safety, the drug regulatory authority responsible for the supervision of the inspected entity shall, after receiving the evidence materials, conduct a risk assessment, make a risk control decision, and order the inspected entity to take corresponding risk control measures.

If a drug manufacturing enterprise is found to be suspected of committing a crime during the investigation of the case, the drug regulatory authority shall promptly transfer or notify the public security organ in accordance with relevant regulations.

(2) Refusal and evasion of supervision and inspection

Where there is evidence to prove that there may be a potential safety hazard, the drug supervision and administration department shall, based on the supervision and inspection situation, take measures such as warning, interview, rectification within a time limit, and suspension of production, sales, use, and import, and timely announce the inspection and handling results.

(3) Defects

If the defect found in the inspection is a defect with a slight quality and safety risk, it can be rectified immediately; in general, after the on-site inspection is over, the drug manufacturer should make corrections for the defective item within 20 working days.
If the rectification cannot be completed on time, a practical rectification plan shall be formulated, and the rectification plan shall be submitted to the inspection team and dispatched inspection units in a timely manner for confirmation; once the rectification is completed, the pharmaceutical manufacturer shall promptly submit the rectification report to the inspection team and dispatched for inspection unit.
When necessary, the dispatched inspection unit may conduct an on-site inspection on the implementation of the rectification of the inspected unit.

to sum up

First of all, to do a good job of receiving official inspections, pharmaceutical manufacturers must operate legally in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and "Measures for the Supervision and Administration of Drug Production" and other relevant laws and regulations.
If a drug manufacturing company operates legally, there will be no suspected crimes.

Secondly, when drug manufacturers are undergoing inspections, they actively cooperate with the inspection team, and there will be no rejection and evasion of supervision and inspection results.
Under normal circumstances, pharmaceutical manufacturers will not refuse or evade supervision and inspection.

Finally, during the inspection, the pharmaceutical manufacturer sincerely accepted the defects found by the inspection team and actively carried out rectification.
Not only will it continue to improve the management system of drug manufacturers, but it will also leave a good impression on the drug supervision and management department and the inspection team, thereby achieving the result of reducing the frequency of inspections.

In short, to receive drug inspections (official inspections) well, pharmaceutical manufacturers must first pass training to familiarize employees with the requirements of relevant laws and regulations, and carry out production in accordance with the requirements of laws and regulations, so as to achieve legal production and legal operations.
Secondly, through training, let the leadership understand the consequences if suspected of breaking the law; let the management understand the consequences if they refuse and evade supervision and inspection.
Finally, through training, let all staff understand the consequences of defects found in inspection.
At the same time, let the company's leadership and management understand the significance of actively rectifying the defects that have been found.