How should pharmaceutical manufacturers receive official inspections of drugs

background

On May 31, 2021, on its official website, the State Drug Administration issued the "Notice of the State Drug Administration on Printing and Distributing the "Measures for the Administration of Drug Inspection (Trial)" (National Drug Administration [2021] No.
31)" on its official website.
Measures for the Administration of Drug Inspection (for Trial Implementation)" and will be implemented from the date of promulgation (that is, May 31, 2021)
.

The author briefly sorted out the "Administrative Measures for Drug Inspection (Trial)" and compiled a list of official inspections received by drug manufacturers for readers

text

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

This article will explain the basic knowledge of drug inspection, acceptance inspection process and inspection follow-up work

1.
Basic knowledge of drug inspection

(1) Classification of drug inspection

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

(2) The inspection found

1.
Suspected of breaking the law

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.
Refuse and evade supervision and inspection

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

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"
.

If a drug manufacturer repeats the defect found in the previous inspection, the risk level can be upgraded

(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.
Welcome the inspection process

       (1) Participate in the first meeting

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

If the official holds the first meeting, the relevant personnel of the pharmaceutical manufacturer should actively participate in the first meeting convened by the inspection team

       (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

       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 that the requirements are met, 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 official seal of the company for confirmation

       If the inspection conclusion is basically in compliance with the requirements or not in compliance with the requirements, the drug manufacturer's inspection conclusions have objections, they can state their defense
.

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

       3.
Follow-up work after inspection

       (1) Suspected of illegal

       If the suspected illegal act may have drug quality and safety risks, the drug regulatory authority responsible for the supervision of the inspected unit shall, after receiving the evidence materials, conduct a risk assessment, make a risk control decision, and order the inspected unit 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 warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and imports, and promptly 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 completed, 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 for confirmation; once the rectification is completed, the drug manufacturer shall submit the rectification report to the inspection team and dispatched for inspection in a timely manner 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 pharmaceutical 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 results that reduce 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 inspections
.
At the same time, let the company's leadership and management understand the significance of actively rectifying the defects that have been discovered
.

       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
.