Sorting Out The Self-Inspection Process Of Pharmaceutical Production Enterprises

Self-inspection methods can be divided into three types: data inspection, face-to-face communication and on-site inspection. This paper explains the necessity of self-inspection for drug manufacturers, introduces the feasibility and function of self-inspection, and provides specific methods for drug manufacturers to carry out self-inspection.

For drug manufacturers, carrying out self-inspection work is beneficial and harmless: it can meet the requirements of laws, regulations and standards such as the Drug Administration Law, and the self-inspection reports formed by it are also a must-see for various audits and inspections content; more importantly, through self-inspection, drug manufacturers can identify opportunities for improvement and achieve the purpose of continuous improvement of their quality management system. In particular, with the abolition of drug GMP (Good Manufacturing Practice) certification, the self-discipline management of enterprises becomes more important. The self-inspection of drug manufacturers is an important guarantee for their continuous implementation of GMP and strict enforcement of laws and regulations.

Part 1 Regulations Require Self-Inspection

To engage in drug production activities, one shall abide by the drug production quality management regulations, establish and improve the drug production quality management system, and ensure that the entire process of drug production continues to meet statutory requirements.

The quality management department shall regularly organize self-inspection of drug manufacturers, monitor the implementation of the “Good Manufacturing Practice for Drugs (Revised in 2010)” (hereinafter referred to as the “Standard”), evaluate whether the drug manufacturer complies with the requirements of the “Standard”, and Propose necessary corrective and preventive actions. The self-inspection should be carried out on a regular basis for institutions and personnel, plants and facilities, equipment, materials and products, confirmation and verification, document management, production management, quality control and quality assurance, commissioned production and commissioned inspection, product shipment and recall, etc. Check. An independent, systematic and comprehensive self-inspection should be conducted by the personnel designated by the enterprise, and an independent quality audit can also be conducted by external personnel or experts. Self-inspection should be recorded. After the self-inspection is completed, there shall be a self-inspection report, which shall at least include all the conditions observed during the self-inspection, the conclusion of the evaluation, and the proposed corrective and preventive measures. The self-inspection shall be reported to the senior management of the enterprise.

Pharmaceutical manufacturers should carry out self-inspection every year to monitor the implementation of the GMP, evaluate whether the enterprise complies with the requirements of relevant laws and regulations, and propose necessary corrective and preventive measures.

Part 2 How To Carry Out Self-Test

In order to ensure that the self-inspection work meets the relevant requirements and is carried out according to the plan, pharmaceutical manufacturers need to establish a self-inspection plan. The self-inspection plan generally includes objectives, scope, reference documents, definitions, responsibilities, work content, relevant documents and records.

1 Self-Inspection Audit Plan

First of all, the self-inspection should formulate an annual audit plan. At the end of each year, the personnel designated by the Quality Management Department will formulate the self-inspection plan for the next year, which will be implemented after approval. Secondly, a single plan should also be formulated. Before each self-inspection, the person in charge of quality management shall appoint a self-inspection team leader. The team leader should set up a self-inspection team and formulate a single self-inspection plan.

2 Start Of Self-Test

The self-inspection team should first communicate with relevant personnel on the self-inspection objectives, scope, methods and schedule. Determine the feasibility of a self-check and the time and resources required to implement it.

3 Preparation For Self-Inspection Activities

3.1 Establish A Self-Inspection Team

Before each self-inspection, the person in charge of quality management shall issue a notice of self-inspection on the specified date before the self-inspection. After issuing the self-inspection notice, the person in charge of quality management shall appoint the self-inspection team leader. The team leader should set up a self-inspection team. For the self-inspection team, the self-inspection team leader selects qualified personnel in the company according to the self-inspection items, scope and department.

3.2 Preparation Of Audit Schedule

Before each self-inspection, the team leader should formulate a self-inspection schedule, the specific content is as follows:

(1) Determine the scope and goals of self-inspection: For pharmaceutical companies, the scope of self-inspection includes covered products, regions and standard requirements; the goal of self-inspection is to evaluate whether the company’s quality management system complies with relevant laws through self-inspection The requirements of regulations, standards, norms and quality management system documents established by enterprises.

(2) Determine the standards based on self-inspection: For pharmaceutical companies, the basis for self-inspection is relevant laws and regulations, standards, norms and quality management system documents established by the enterprise.

(3) Check the self-inspection team: the self-inspection personnel generally need to work in the drug production enterprise for more than one year, or have relevant qualifications and be approved by the person in charge of quality management; they need to have received relevant internal or external training of the company, and hold relevant certificates; At the same time, self-inspection personnel cannot self-inspect the business directly related to their duties; if necessary, self-inspection personnel can be properly trained.

(4) Formulate the itinerary

① Determine the self-inspection date and daily self-inspection time: it is advisable to start the daily self-inspection one hour after work, so that all departments can calmly arrange the work of the day and concentrate on accepting the self-inspection.

② Determine the specific content of each self-inspection and the specific personnel of the self-inspection team.

③ Planning the first meeting: In the first self-inspection meeting, it is necessary to specify the personnel who will participate in the self-inspection, the duration of the first meeting and the problems to be solved at the first meeting.

④Planning final meeting: If possible, the final meeting can be arranged on the day after the self-inspection ends, so as to ensure that the team has enough time to discuss and complete the defect report.

⑤ Determine other matters related to this review. For example, if a drug manufacturer implements a multi-shift system, when planning a plan, it is necessary to plan the self-inspection of the night shift.

3.3 Assign Self-Inspection Team Work

Before each audit, the self-inspection team leader will assign work to the self-inspection team. The self-inspection team needs to be divided into several groups, and different groups are responsible for different self-inspection contents.

3.4 Prepare Relevant Documents

Before each self-inspection, the respective inspectors can borrow relevant documents from the document management center according to the theme of the self-inspection to prepare for the self-inspection.

4 Implementation of self-inspection activities

4.1 Hold The First Meeting

Before the formal audit, the first meeting shall be presided over by the self-inspection team leader. According to the plan, all relevant personnel must attend the meeting, sign in and take photos. The meeting mainly includes the following contents: determine the self-inspection scope, objectives and methods used during the self-inspection; introduce self-inspection members; determine the self-inspection schedule, the time of the last meeting and the participants of the meeting.

4.2 Collect And Verify Information

(1) Complete the checklist: self-inspection personnel should prepare a checklist before self-inspection to assist in the self-inspection work. The following items should be considered in the design of the checklist: the content of the checklist should be formulated according to relevant documents; the design of the checklist should be planned with the principle of assisting memory to ensure the continuity and depth of the self-check.

(2) Implement self-inspection

①Self-inspection method adopted: When the self-inspection team conducts self-inspection, it should collect objective evidence by checking documents, face-to-face communication and on-site inspection. The primary task of reviewing documents is to confirm whether the document management system of the drug manufacturer complies with relevant laws, regulations, and standard requirements, and to determine the adequacy and compliance of its document management system; Whether the work can be carried out according to the planning of the company’s documents; the on-site inspection is to determine whether the relevant elements to be inspected on the site meet the relevant requirements.

②Self-inspection: Self-inspection personnel can use the checklist when conducting self-inspection to ensure the continuity of audit work; self-inspection personnel should pay attention to the application of self-inspection principles and skills when conducting audits. Precautions for self-inspection include: self-inspection is not carried out in the meeting room or office, but at the “work” site; self-inspection needs to be conducted under the leadership of self-inspection personnel; self-inspection personnel should grasp the self-inspection goals and not exceed self-inspection Scope; should conduct self-examination based on objective facts and obtain objective evidence, be alert to any signs that could affect self-examination results or may require further self-examination; confirm and clarify all “verbal” information; use memo to record matters to be verified ;Use idioms of pharmaceutical manufacturers to reduce communication barriers.

(3) Fill in the checklist: self-inspectors must immediately fill in the checklist and attach necessary evidence for defects found during the self-inspection process.

4.3 Form Self-Test Findings

(1) Self-test found

Self-inspection personnel compare self-inspection evidence with self-inspection criteria to form self-inspection findings. Self-inspection findings can be divided into strengths and weaknesses. For the advantages found in the self-inspection process, the enterprise should continue to maintain; for the defects found, the enterprise needs to take measures as soon as possible to improve.

(2) Defect classification

Defects can be categorized as critical, major and general.

Serious defect refers to a defect that seriously deviates from the GMP requirements of pharmaceuticals and may cause the product to cause harm to users. Any of the following situations is a serious defect: causing harm to users or posing health risks; seriously deviating from drug GMP requirements and bringing serious risks to product quality; having untrue deceptive behavior such as documents, data, records, etc.; There are many related major defects, and a comprehensive analysis shows that a certain system in the quality management system cannot operate effectively.

The main defect refers to the defect that deviates greatly from the requirements of drug GMP. One of the following situations is the main defect: there is a large deviation from the requirements of drug GMP, which will bring greater risks to product quality; the product cannot be released as required or the quality authorized person cannot effectively perform its release duties; there are multiple relationships General defects, comprehensive analysis shows that a certain system in the quality management system is not perfect.

General defects refer to defects that deviate from the GMP requirements of pharmaceuticals, but have not yet reached the level of serious defects and major defects.

4.4 Preparing Audit Conclusions

The self-inspection team shall, under the auspices of the self-inspection team leader, discuss self-inspection findings, determine defect items, and comprehensively sort out the advantages and disadvantages of the inspected department.

4.5 Hold Closing Meeting

After completing the self-inspection work according to the self-inspection checklist and before writing the self-inspection report, the self-inspection team leader should host the final meeting so that the management personnel can clearly grasp the self-inspection results. According to the plan, all relevant personnel must attend the meeting, sign in and take photos.

According to the plan, the participants in the final meeting included the self-inspection team and relevant personnel of the inspected department. The meeting has the following content: reaffirm the scope and goals of this self-inspection; report the self-inspection results and self-inspection findings, and report the defects found in order; if the defects can be eliminated after further discussion or additional evidence is provided by the inspected department, the The self-inspection team leader ruled to cancel the defect and marked it in the inspection list. Announce corrective or preventive measures, issue and follow up according to the control procedures of corrective and preventive measures; report the main obstacles encountered in the self-inspection process; propose the date of issuance of the self-inspection report.

5 Preparation And Distribution Of Self-Inspection Reports

5.1 Preparation

According to the plan, the self-inspection team leader should complete the preparation of the self-inspection report within the specified time after the self-inspection work is completed; it should be noted that the self-inspection report must be signed by the self-inspection team leader and the person in charge of the quality management department.

The main contents of the self-inspection report include: self-inspection objectives, self-inspection scope, self-inspection criteria, self-inspection team, self-inspection date, self-inspection findings – including strengths, weaknesses, data analysis, conclusions and preparation and approval of reports.

5.2 Distribution

According to the plan, the original copy of the audit report is kept by the document management center, and the copies are distributed to relevant personnel.

5.3 Completion Of Self-Test

A self-test is complete when all planned self-test activities have been performed.

5.4 Implementation Of Self-Inspection Follow-Up Activities

(1) Issue and follow-up of corrective and preventive measures

For the defects found in the self-inspection, corrective and preventive measures shall be implemented, and follow-up and control shall be carried out according to the “Control Procedures for Corrective and Preventive Measures”.

After the final meeting, the self-inspection team should fill in the relevant content of the “Corrective and Preventive Measures Handling Sheet” for each defect recorded on the inspection form within the specified time, and the self-inspection personnel found will follow up until the rectification is completed. After all corrective and preventive measures are completed, the self-inspection team leader will confirm and close the case.

(2) Report to the management team

The person in charge of the quality management department should second the self-inspection report (including other relevant records) to the document management center, submit the relevant content of the internal management system self-inspection to the management team, and report the status of this self-inspection.

5.5 Record Keeping

All self-inspection records should be kept by the document management center, and should be kept for a certain period of time according to the plan. The records that must be kept for self-inspection include: self-inspection schedule, inspection form, self-inspection defect report, corrective and preventive measures processing sheet, self-inspection report, first meeting sign-in form and meeting photos, last meeting sign-in form and meeting photos.

Part 3 Conclusion And Discussion

Self-inspection work is one of the important links to ensure the quality of drugs. Drug manufacturers should carry out regular self-inspection in accordance with the requirements of laws and regulations. This article describes the whole process of self-inspection carried out by drug manufacturers, and provides methods and references for drug manufacturers to effectively carry out self-inspection activities.