PMDA ORANGE LETTER_2022.12
ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: December 2022
Title: Improper record
Source: https://www.pmda.go.jp/files/000249492.pdf
Related GMP Ministerial Ordinance Clause: Item 3&4 of Article 10
1. Case
Records were created based on speculation
2. Background
● GMP ministerial ordinance stipulates that manufacturing operations should be carried out based on manufacturing instructions and that records should be kept.
● As for the process of washing the API crystals, it was instructed in the production instruction to confirm and record whether there is discrepancy between the amount of washing solvent actually used and the amount specified in the production instructions of the manufacturing site.
● The actual amount used is calculated by subtracting the "value at the start of washing" from the "value at the end of washing" using an integrated flowmeter.
● A specified amount of washing solvent can be automatically added using a flowmeter that can be set to the specified amount.
3. Observations
● At the start of the washing process, the operator in charge forgot to check the value of the integrated flowmeter and record it in the production record.
● Since 'the value at the start of washing' is unknown and the actual amount used cannot be calculated, the amount instructed by the instruction is recorded as the amount used. Also, "value at the start of washing" is calculated using the instructed amount and recorded.
● The fact that “value at the start of washing” has not been confirmed and recorded, and the record was created based on the instructed amount was not reported to the responsible person, nor was it recorded in the production record.
4. Problems/Risks
● Since records are not based on real operations, it failed to implement production according to determined production method and it may cause risk of impacting the product quality.
● In the case of quality defect, there existed the risk that proper cause investigation has not been conducted.
5. Check Points
● Is the work environment conducive to reporting human errors?
● Is deviation handling system available when operations differing from the instructions have been performed?
● Have rules for record correction and note been properly defined?
6. Catchword
Honest reporting of mistakes is the first step to the next improvement activity!!
◇ The basis of GMP is to record the truth as what it is honestly. It is inappropriate to patch up records when mistakes occur.
◇ If improper record was confirmed, not only the record itself, but also the credibility of all records at the manufacturing site will be lost.
◇ Even individual events are with low quality risk, they can lead to major deficiencies that have a significant impact on quality when accumulated.
◇ Rather than blaming the mistakes themselves, it is important to build a system and foster a corporate culture that will lead to proper picking, root cause investigation, and prevention of recurrence!
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