ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: October 2023
Title: Communication within the organization (from management to manufacturing sites)
Source: https://www.pmda.go.jp/files/000265006.pdf
Related GMP Ministerial Ordinance Clause: Paragraph.1 Article 12 ,Paragraph.2 Article 21
1. Case
The management did not grasp the correction status of the manufacturing site.
2. Background
◆ The following requirements regarding pharmaceutical quality systems are stipulated in the GMP Ministerial Ordinance.
(1) Effective pharmaceutical quality systems should be built.
(2) Adequate resources should be available so as to achieve the "quality policy", which is the basic policy for ensuring product quality, and the "quality objectives" based on the quality policy.
(3) Periodical product quality system review should be carried out, and adequate measures should be taken according to the results.
3. Observations
◆ During the management review, it was reported that quality tests, etc., had not been conducted due to lack of personnel and insufficient training, and the management ordered to improve the personnel training and personnel allocation as soon as possible.
◆ Although several new staff were employed, training and proper staff allocation failed to be done, and problems such as deviation due to improper resource allocation continued.
◆ The management thought that problems had been solved since employees had been increased, however all the problems remained unsolved because of insufficient follow-up and improvement instructions after the management review.
4. Problems/Risks
◆ If the improvement cycle for solving problems is not able to function properly, there is a risk that the manufacturer could not fulfill the responsibility of supplying products of the required quality to the market stably and constantly.
5. Check Points
◆ Whether work stoppage and pharmaceutical quality system malfunction occurs because most workload are borne by several specific personnels？
◆ Whether the improvement measures based on the results of management reviews are realistic, and measures are in place to achieve them?
◆ Whether the management confirms that the pharmaceutical quality system is functioning effectively after instructing improvement measures?
6. Catchword
Whether the management are able to grasp the actual situation of the manufacturing site?
✓ Management should monitor the manufacturing site even after giving instructions for improvement. In case that improvement is not achieved, other than human resource allowance, they should consider multifaceted measures for work efficacy improvement through systemization.
✓ In particular, if the issues require immediate improvement at the manufacturing site, it is important for management to actively follow up on-site information, rather than waiting for reports .
✓ Even though there is no need for the management to grasp all the information, it is desirable to establish a reporting system that allows the management to obtain true and accurate information from the manufacturing site.
About Author
Career The profile is the information as of the time of writing.
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