2022 Volume 71 Issue 2 Pages 129-139
A revised version of the Japanese GMP Ministerial Ordinance was issued in April 2021, and the implementation of the Pharmaceutical Quality System (PQS) was added as a new requirement. The quality system originated in the ISO9001 standard; further, ISO9001 states that quality assurance of a product consists of the manufacturing process conducted under the quality system and the quality of the product itself. The Pharmaceutical Quality System Guideline—ICH Q10—is a specified guideline, according to the concept of ISO9001, for pharmaceutical manufacturing through the product life cycle, from development to product termination. Finally, the GMP Ministerial Ordinance was established by referring to Q10 and Q10 based PIC/S -GMP. Therefore, the PQS is regarded a core quality requirement in GMP Ministerial Ordinance.
Article 3-3 of the GMP Ministerial Ordinance defines the PQS. The essential points of this article from the perspectives of ISO9001 and Q10 are summarized as follows:
First, senior management is responsible for achieving the PQS and is asked to contribute adequately to product quality. It should be noted that the responsibility of senior management has been criticized for several quality and GMP noncompliance issues in the Japanese pharmaceutical industry. Next, senior management should establish a quality policy promoting awareness among people associated with the company. Senior management should then ensure quality objectives to implement the quality policy and provide appropriate resources and training to help the manufacturer achieve them. Performance indicators (PI) that measure progress against quality objectives should be established and integrated into quality metrics. Senior management should evaluate the effectiveness of the PQS using quality metrics comprising PI. This assessment process is conducted as a management review, as evidenced by the fact that a review of past activities of the PQS where quality issues are clarified encourages continual improvements. Finally, the entire PQS process from establishing the quality policy to the management review, including daily GMP activities and periodic checks for them, can be described as a PDCA cycle. Suitable application of the PDCA cycle to the PQS introduces continual improvements. The PQS structure described above was reviewed and documented as a quality manual at a production site.
Establishing quality assurance in Japanese pharmaceutical companies advances to a new era with the PQS defined in the GMP Ministerial Ordinance. Further challenges for pharmaceutical companies are expected to ensure product quality.
