ORANGE LETTER
Observed Regulatory Attention/Notification of GMP Elements Letter
The Orange Letter is a series of GMP survey findings that are considered particularly useful for the industry to be made known to the public, and will be published starting this fiscal year (2022) as a reminder and technical reference. The purpose of the letter is to encourage voluntary improvements in quality at each manufacturing facility and to strengthen management and supervision by manufacturers and distributors.
Preliminary report on GMP case studies, April, 2022
Title: Importance of confirming the suitability of raw materials for pharmaceutical use
Source: https://www.pmda.go.jp/files/000246311.pdf
Related GMP Ministerial Ordinance Clause: Article 10 paragraph 5
1. Case
Confirmation of supplier upon the receipt of raw materials was not properly conducted.
2. Background
● The GMP Ministerial Ordinance requires that the suitability of raw materials should be checked for each lot, and the results should be documented.
● The procedure of the manufacturing site says that the supplier's name should be confirmed by the label adhered to the container upon receipt of raw materials and should be recorded.
3. Observations
● The manufacturer's name is not listed on the label adhered to the container of raw material A. However, it is recorded in the acceptance record the manufacturer's name was confirmed by the label adhered to the container.
● In fact, the person in charge of receiving checked the test report for the manufacturer's name of raw material A rather than the label adhered to the container directly.
4. Problems/Risks
● Failure to check the label adhered d to the container may result in the receipt of wrong raw materials instead of correct ones and this may be not detected.
● The use of the wrong raw materials has a significant impact on the quality of the product that made form the raw materials.
5. Check Points
● Whether labels are checked and recorded according to the procedure? (If not, cause investigation, appropriate correction, and impact assessment are required.)
● Do operators understand the meaning of their work (the meaning of conducting label confirmation)?
● Is there an awareness of observing procedures(compliance) throughout the manufacturing site?
6. Catchword
Your "confirmation" creates quality !
◇ In recent years, incidents that oral antifungal products were mixed with sleep-inducing drugs due to mix-ups of the wrong raw materials and finally resulted in the death of patients who took them occurred.
◇ In order to reduce the risk of mixing up raw materials, it is necessary to conduct label confirmation by multiple departments from receipt of raw materials to materials feeding in the manufacturing process. On the other hand, these risk reduction measures lose is nonsense if the label information and incoming raw materials are not appropriate in the first place.
◇ Therefore, it is extremely important to thoroughly check the contents of the label when receiving raw materials, and this is the basic of preventing mix-up of raw materials.
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