Manufacturing and Quality Control Systems at Pharmaceutical Manufacturers

Issuance of “Manufacturing and Quality Control System for Manufacturers of Pharmaceutical Products (Office Communication)

On January 31, 2022, the Ministry of Health, Labour and Welfare issued an administrative communication entitled “Manufacturing and Quality Control Systems of Pharmaceutical Manufacturers” on January 31, 2022.

Requirements for personnel availability at manufacturers of pharmaceutical products

The personnel requirements for manufacturers of pharmaceutical products are stipulated in Article 6, Paragraph 3 of the GMP Ministerial Ordinance as follows

Article 6

3 Manufacturers, etc. must ensure that they have sufficient personnel with the ability to properly perform manufacturing and quality-related tasks.

GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Pharmaceuticals and Quasi-Drugs)

On the other hand, one of the causes of the quality problems that have been occurring recently is the lack of proper staffing at manufacturing facilities.
Therefore, the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) has decided to issue the “Approach to Manpower Security at Manufacturing Plants” in the form of an administrative communication through the Ministry of Health, Labor and Welfare, which was formulated based on the results of a questionnaire survey conducted among its member companies.
Whether the manufacturer has secured a manufacturing and quality control system commensurate with the number of items manufactured, the amount manufactured, etc., will be confirmed in the conformity survey conducted during the approval review of post-marketing drugs for medical use. (Based on: “New Measures at the Time of Approval Examination of Post-approval Drugs for Medical Use” (Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Administration Division Director and Monitoring Guidance and Drug Control Division Director jointly issued notice No. 0702-5 dated July 2, 2021))
It is required to confirm and review the personnel system with reference to this administrative communication.

Approach to Staffing in Pharmaceutical Manufacturing Plants

The “Manufacturers of Pharmaceutical Products The “manufacturing and quality control system at pharmaceutical manufacturers” is about personnel (including non-permanent employees) engaged in manufacturing and quality-related work,

  1. Manufacturing Division
  2. Quality Assurance (QA) Department
  3. Testing and Inspection (QC) Division
  4. Engineering (manufacturing, testing, equipment modification, and maintenance of equipment, etc.)

The following table shows reference values for the annual number of items and lots handled per person in the four categories of

Also shown are the reference ratios of personnel in the quality (QA + QC) and QA departments to the total number of personnel in the above four categories.

For more information, see the text of “Manufacturers of Pharmaceuticals For more information, please refer to the main text of “Manufacturing and Quality Control Systems of Pharmaceutical Manufacturers.

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