ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: October 2023 (Part 2)
Title: Communication within the organization (from manufacturing sites to the management)
Source: https://www.pmda.go.jp/files/000265005.pdf
Related GMP Ministerial Ordinance Clause: Paragraph.3 Article 3
1. Case
The actual situations of the manufacturing site were not be accurately reported.
2. Background
◆ The following requirements regarding pharmaceutical quality systems are stipulated in the GMP Ministerial Ordinance.
(1) Effective pharmaceutical quality system 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.
◆ More than 50 non-sterile products were manufactured at the manufacturing site.
3. Observations
◆ Due to a chronic shortage of personnel, stability tests plan were frequently delayed. In addition, more than 30 products had not been carried out product quality review over 3 years.
◆ Because manufacturing managers did not report accurate status to management, drastic improvement measures such as hiring more personnel or reviewing workloads were not been conducted. As a result, the pharmaceutical quality system dysfunction has lasted for a long time..
4. Problems/Risks
◆ If information of manufacturing site were not properly reported to the management, and the pharmaceutical quality system were not functioning, problems will remained unsolved. As a result, even if serious defect of product quality occurs, detection of the quality problem will be delayed or that appropriate measures will not be taken to resolve the problem, and finally products with defects may be supplied to the market.
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 actual situation of the manufacturing site can be accurately reported to the management?
✓ It is important to actively communicate with management, such as providing necessary information from the manufacturing site at the appropriate time. It is important to foster a culture in which employees can report the ``truth'' of the workplace, including the good and bad.
✓ Production managers and the quality assurance department should establish a system in which urgent matters are immediately and other issues are reported in arranged priority order. Meanwhile, management review should be applied so that all the issues are reported to the management.
✓ If the manufacturing site can regularly confirm whether the pharmaceutical quality system is functioning properly and present improvement proposals to management, it can be expected that the time to resolve problems could be shortened.
About Author
Career The profile is the information as of the time of writing.
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