ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: October 2024
Title: Findings related to discrepancies with approved dossier and fake record
Source: https://www.pmda.go.jp/files/000271235.pdf
Related GMP Ministerial Ordinance Clause: Please refer to the detailed case.
1. Case
<Summary of findings>
⚫ The production department are found to conduct production without complying with approval dossiers and procedures and make fake records (hereinafter referred to as "improper acts"). In addition, it was found that the factory manager and responsible person were involved in some of the improper acts.
⚫ The improper acts were not reported to the quality department or manufacturing manager, and the impact on product quality had not been evaluated.
⚫ The manufacturing site had previously conducted a comprehensive self-inspection of production and quality control, but some issues were overlooked.
＜Violations of GMP Ordinance＞
⚫ The improper acts are mainly as follows. [Not conforming with Article 10 (iii), (iv), and (x) , and Article 20 (2) of the GMP Ordinance]
⚫ Manufacturing using residual powder from multiple lots and additional drying were carried out, which were not based on production instructions. In addition, there were no appropriate records.
⚫ The date and time of issuance of the additional production instruction and record blank form was backdated to the previous date etc.
⚫ The necessary deviation control and change control were not carried out. Furthermore, the impact on product quality, cause investigation, correction actions and preventive actions were not carried out. [Not conforming with Article 14 and Article 15 of the GMP Ordinance]
⚫ The quality assurance department was unable to conduct product release appropriately. [Not conforming with Article 12]
⚫ As a result, false reports were made to senior management during the management review. As a result, senior management was unable to review the pharmaceutical quality system and take necessary measures based on the results.
<Summary of improvement instructions>
⚫ As there is a possibility that other improper acts may exist, we have instructed them to take at least the following 3 actions to investigate the causes of the improper acts, evaluate the impact on product quality, and take necessary measures.
⚫ Investigating the reasons why the responsible person failed to detect the malfunction of the pharmaceutical quality system at the manufacturing site
⚫ Evaluating the reconcilement between the procedure, the production instruction, records and the actual situation
⚫ Evaluating whether the contents written in the procedures and the production instructions and records is appropriate.
2. Catchword
Are all the staff aware of "putting regulation compliance first" when performing their duties? Please check again if the management and responsible persons acquire the actual situation on site!!
⚫ The management
✓ Do you adequately understand and comply with the law, and clearly show staff what they should be like?
✓ Have you allocated the necessary resources and eliminate factors that hinder staff's motivation?
✓ Have you built a reliable relationship within the company that allows staff to quickly report negative information?
⚫ Responsible persons
✓ Are you reporting the actual situation and issues of the manufacturing site to the management through management reviews, etc.?
✓ Have you checked the reconcilement of the actual operation with not only the approval dossiers and MF, but also the procedures and instructions, and taken immediate action to address any insufficient or non-reconcilement?
⚫ Operators
✓ Do you understand that your work is directly related to the quality of pharmaceuticals and, ultimately, the lives and health of patients (it is unrealistic to be aware of this all the time while performing your work, but are there moments when you are aware of it from time to time?)
✓ Have you acquired the habit of recording the work you actually performed and the decisions you made “as is”?
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