ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: March 2024
Title: Communication within the organization (from management to manufacturing sites)
Source: https://www.pmda.go.jp/files/000267527.pdf
Related GMP Ministerial Ordinance Clause: Article 17(2)
1. Case
Products that are rejected for use or release were not properly disposed.
2. Background
◆ The GMP Ordinance stipulates that following tasks should be conducted by appointed personnel, in accordance with the written procedures, etc., when storing and disposing the starting materials, packaging/labeling materials and products, which are rejected for use or release.
◆ Properly disposal after separate storage for a certain period. Records of storage and disposal must be created, kept and reported in writing to the organization in charge of quality assurance work and the manufacturing manager.
◆ The manufacturing defined in its procedures as follows.
① Affix "under testing" to products undergoing release testing and stored them at "under testing" area.
② Remove "under testing" label from products that pass the test and moved them to the area for qualified products.
③ Affix "Rejected" label to products rejected for release and moved them to the area for unqualified products.
① Affix "under testing" to products undergoing release testing and stored them at "under testing" area.
② Remove "under testing" label from products that pass the test and moved them to the area for qualified products.
③ Affix "Rejected" label to products rejected for release and moved them to the area for unqualified products.
3. Observations
◆ No one was designated in charge of storing and dispose the products rejected for release, therefore it was unclear who was in charge.
◆ Products rejected for release were placed with the "under testing" label.
◆ Warehouse staff moved products rejected for release to the storage area for qualified products and stored them on top of products that were qualified for release. Final products with different statuses were mixed and stored together.
4. Problems/Risks
◆ Products rejected for release may be shipped because of a system and procedures that is unable to assure that products undergoing release testing be properly handled.
5. Check Points
◆ Whether person in charge and , responsibilities of person in charge and related staffs are clearly defined in procedures?
◆ Whether materials, packaging/labeling materials and products, which are rejected for use or release, are stored and control separately in accordance with the written procedures?
6. Catchword
Establish a system that can deal with unpredictable event at any time!!
✓ Few deficiencies regarding articles on procedures for " disposing the starting materials, packaging/labeling materials and products, which are rejected for use or release" and designation of a person in charge who is familiar with disposal in revised GMP Ministerial Ordinance were found in GMP inspections
✓ It is necessary to determine the procedure in advance for disposing products rejected for release, which occur infrequently and are not familiar to deal with.
✓ In addition to the above, the revised GMP Ministerial Ordinance newly stipulates several articles on designation of a person in charge as a "person designated in advance." .With regard to Pharmaceutical Quality Systems (Article 3-3 (Ⅴ)), Quality Risk Management (Article 3-4 (1)), Control of Outsourced Contractors (Article 11-5 (2) ), and Data Integrity (Article 20 (1) ), it is necessary to reconfirm whether appropriate responsible persons have been appointed at manufacturing site and are performing functions properly.
About Author
Career The profile is the information as of the time of writing.
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