Japanese GMP regulation revised in April 2021
Japanese GMP regulation is revised and issued by MHLW on 28th April. This will be enforced on 1st August.
Official name of the Japanese GMP regulation is ” MHLW Ministerial Ordinance”.
As the last revision was done in 2005, there are massive updates in 2021 revision this time.
( Even though, during 2005-2021, some official notices had been issued as supplementary material.)
Points for Japanese GMP revision
Main points for the revision are as below;
- To align with the international standards such as ICH-Q9 & Q10, PIC/S.
- To fulfill the concept of Quality Assurance.
- To emphasize the importance of compliance.
PMDA trainer explained each point at the work-shop.
First point is,
1. Alignment with international standards
Since the last GMP revision in December 2004, the environments has been rapidly varied.
- 2006 Sep., ICH-Q9 notice issued.
- 2010 Oct., ICH-Q10 notice issued.
- 2013 Aug., GMP notice issued.
- 2014 July, PMDA/MLHW accession to PIC/S.
- 2015-2016, Kaketsuken scandal triggered simultaneous conformity check.
- 2016, Data Integrity guidelines developed.
- 2017, PQS introduced in PIC/S guideline.
Ongoing development of technologies, automation of systems, use of remote technologies, and the increased complexity of global supply chains and ways of working.
Main purpose of the revision is to introduce the global standards.
Next point is,
2. Fulfillment the concept of Quality Assurance
In the revised GMP, in order to differentiate QA and QC, the establishment of QA department and QA related tasks are clearly mentioned. This is to emphasize more importance of QA involvements in GMP activities.
For example, QA should perform the compliance check, annual product review, release procedure, supplier control, validation.
Some experts point out the issue that QA is not independent. In the revised GMP, QA and QC are under a site manager, which is different from a global standard.
Relate to release procedure, such as AP( Authorized person) / QP( Qualified person) is not mentioned in the Japanese GMP regulation.
Last point is,
3. Emphasis on compliance
You might remember the Kaketsuken scandal – major vaccines/blood products maker continued GMP violations for decade.
This triggered simultaneous conformity checks. MA holders had to report the results to the health authority.
Surprisingly, it revealed that 70% of drug products had some discrepancies between contents of approved filing and actual operations.
Even though simultaneous conformity checks had done, recently some critical violations and recalls were found in the generic pharmaceutical industries.
The importance of compliance is emphasized in this revision.
Necessity of continuous conformity check, collaboration between MA holders and Manufacturers are mentioned.
