1.4 Stability Monitoring (GMP Ministerial Order Article 11-2)
When it comes to stability monitoring, many people likely envision the process of collecting and storing stability monitoring samples and then conducting the actual tests at specified intervals.
Of course, the QC department is expected to manage the above activities. However, the article (Table 4) states that stability monitoring must be planned and properly conducted by the entire quality unit, which includes both the QC and QA departments.
Specifically, for selecting the products for stability monitoring and test items (Paragraph 1, Item 2) based on risk identification, evaluation, and results (Paragraph 1, Item 1), it is crucial that the QA department makes the final decision based on achieving quality assurance throughout the pharmaceutical lifecycle, while also considering the knowledge and experience of the QC department regarding testing.
Regarding the evaluation of stability monitoring results (Paragraph 1, Item 4), it is recommended int the GMP Case Studies 2022 Edition (Table 5) that this evaluation be conducted by the QA department. While the QC department may handle the compilation of results and the initial assessment, the final evaluation, which ensures quality assurance throughout the pharmaceutical lifecycle, must be performed by the QA department based on its experience and knowledge. Failing to do so is likely to lead to problems.
Furthermore, based on these evaluation results, necessary measures such as promptly notifying the Marketing Authorization Holder (MAH) and providing information for recall decisions (Paragraph 2) will be taken in collaboration with the QC and manufacturing departments. In practice, it is generally the QA department who takes the responsibility of contacting the MAH and handles the actual response.
(Stability Monitoring)
Article 11-2 (1) Manufacturers, etc. for finished products of pharmaceuticals must have their quality department, systematically and suitably in accordance with the written procedures, etc., conduct the following tasks regarding stability monitoring of such pharmaceuticals:
(2) In the case where any actual or potential out of specifications on finished products of a pharmaceutical has been identified upon outcome of the assessment pursuant to the provisions of item (iv) in the preceding paragraph, the manufacturer, etc. of such products must take necessary actions, such as prompt notifications to concerned marketing license holders of the pharmaceutical, and providing such marketing license holders with information necessary for a decision on product recalls, etc., and document and retain records of such actions.
Table 4: GMP Ministerial Order Article 11-2 Stability Monitoring
GMP 11-2-12 (Stability Monitoring))
[Question] It is stated in Article 11-2（1）Ⅳ of the GMP Ministerial Order that " to assess quality impact on the pharmaceuticals subjected to stability monitoring, based upon results of the testing/analysis pursuant to the provisions of the preceding item; " Regarding this evaluation, should it be performed by the Quality Assurance (QA, the organization in charge of quality assurance-related work?) or the Quality Control (QC, the organization in charge of the department's testing and inspection-related work) department? 」, or
[Answer] Regarding the evaluation under Article 11-2（1）Ⅳ of the GMP Ministerial Order, because objective evaluation is required, it is expected that the organization in charge of quality assurance activity in quality department conducts the evaluation.
Table 5: GMP Case Studies 2022 (Excerpt)
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