ORANGE LETTER
Author:
PMDAObserved Regulatory Attention/Notification of GMP Elements LETTER
Issue: September 2022
Title: Importance of thorough contract manufacturing management
Source: https://www.pmda.go.jp/files/000248233.pdf
Related GMP Ministerial Ordinance Clause: Paragraph 5 of Article 11
1. Case
When contracting tests, the qualification and capacity of the contract receiver had not been confirmed adequately.
2. Background
● It is stipulated in GMP ministerial ordinance that when a manufacturer, etc. contracts "part of manufacturing and quality control such as testing," it is necessary to conclude an agreement after confirming the qualification and capability of the contract receiver.
● The manufacturer contracts some pharmaceutical tests and examinations after signing an agreement with an external testing institution.
3. Observations
● During test contracting, technology transferring to the external testing institutions had not been appropriately conducted and whether the scheduled test can be carried out properly had not been confirmed.
● Despite the fact that the qualification and capability of the external testing institutions had not been confirmed, agreement was concluded, and tests contracting was started.
● Similar cases can be seen here and there, not only in tests scheduled to be outsourced, but also in tests that had already been contracted.
4. Problems/Risks
● Even if the external testing institution conducts the test using the same test method as the contract giver, test environment (analytical apparatus, reagent manufacturer, test water, temperature and humidity of the test room etc.), organization (e.g., analyzers' proficiency, management system for analytical apparatus, etc.) are different from those of the contract giver, so if technology transfer is insufficient, there is a risk that appropriate test results cannot be obtained.
● There is a risk that drugs will be released based on inappropriate test results, which results in the distribution of defective drugs that do not meet the intended quality.
5. Check Points
● Have the contract giver confirmed and assured that audits, technology transfer etc. to the contract receivers had been performed, and the contract receivers have a system that allows them to carry out their duties appropriately, and their analysis capability and equivalence etc. are qualified.
● Have necessary arrangement been concluded to clarify matters including provisions of GMP Ministerial Ordinance which the contract receiver should comply with?
● Does the contract giver confirm periodically whether the contract giver conducts manufacturing and quality control work properly and smoothly, and ask for improvement if there are any deficiencies?
6. Catchword
Work can be contracted, “responsibility” cannot be contracted !!
◇ Prior to concluding an agreement, the contract giver must assess the contract receiver's qualification and competence to conduct the contract work.
◇ It is important for the manufacturer to (1) provide information and knowledge necessary for implementing the contract work, (2) periodically check the contract receiver's ability to perform the contract work and the status of implementation, and (3) require improvements under their responsibilities as contract giver .
◇ It is important for contract receiver to proactively obtain technical information from contract giver so that they can carry out their duties appropriately!
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