ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: March 2023
Title: Risk caused by failure to follow procedures
Source: https://www.pmda.go.jp/files/000251353.pdf
Related GMP Ministerial Ordinance Clause: Article 10
1. Case
Product are mislabeled.
2. Background
● It is stipulated in GMP ministerial ordinance that activities related to manufacturing management should be carried out according to procedures.
● In order to avoid mistake, the following operations are specified for each product in procedures.
(1) Connect the raw material container with the product container and remove the impurities in raw material by filtering.
(2) Adhere the label to the product containers and compare it with the label of raw material by scanning barcode.
(3) Remove the raw material container and ship the product container.
(1) Connect the raw material container with the product container and remove the impurities in raw material by filtering.
(2) Adhere the label to the product containers and compare it with the label of raw material by scanning barcode.
(3) Remove the raw material container and ship the product container.
3. Observations
● It was found that labels different from the content in containers was attached to the products manufactured at the manufacturing site.
● After investigation, it was found that a series of operations related to multiple products had been carried out collectively which violated procedure and caused mix-up of labels of products. (Mislabeling was not detected even with bar code verification.)
● In addition, due to a chronic shortage of personnel, etc., the description in procedures remained unclear and it was found that many operators did not follow the procedures (assignment of work outside their responsibility, implementation of work before production instructions, etc. is issued). "
4. Problems/Risks
● Serious health hazards may arise if mislabeled drugs are shipped and used by mistake.
5. Check Points
● Are the potential risks of failure to follow the SOPs understood by all employees of the manufacturing site?
● Are the operations are described in detail in procedures (Whether different operators have different understanding)?
● Are there sufficient personnel to carry out the work in accordance with the procedures?
● Is there a mechanism for detecting and tracking in the following steps even if human error or defects occur?
6. Catchword
Following Procedure = Protecting “Patients” and “Yourself”!!
◇ It is necessary to correctly convey drug information to patients so that they do not take other drugs or misuse them. For that reason, it is a critical principle that medicines are labeled correctly. Even for high-quality pharmaceutical products, if that are not properly labeled, they can do a lot of harm but no good to patients.
◇ Human error can happen anytime, anywhere. There is no need to describe the procedure in detail blindly. In order to decrease human errors, it is more important is to create procedures and mechanism by which the operators understand the purpose of their operations and they can implement without difficulty!
About Author
Career The profile is the information as of the time of writing.
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