ORANGE LETTER
Author:
PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER
Issue: December 2022
Title: Improper correction of record to make coincidence with instruction
Source: https://www.pmda.go.jp/files/000249494.pdf
Related GMP Ministerial Ordinance Clause: Item 3&4 of Article 10
1. Case
Record was amended to make coincidence with instruction.
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 API milling process, it is defined in the production instruction that the mill should be stopped 30 minutes after the supply hopper was confirmed empty.
● The time when hopper was confirmed empty’ and 'The time when milling was completed' should be filled in the production record.
3. Observations
● Operator recorded ‘The time when hopper was confirmed empty’. 15 minutes after that, the operator stopped the mill and recorded ‘The time when hopper was confirmed empty’. The same mistaken operation also happened at other lots.
● The operator found the deviation from the production instruction and crossed off ‘The time when hopper was confirmed empty’ for the reason of 'Entry error ' and corrected it to the time 30 minutes before 'The time when milling was completed'
● Similar inappropriate correction were carried out in other lots. However the responsible person didn't detected any of these.
4. Problems/Risks
● When deviations occurred between instruction and the real operation, 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?
● Whether the records are appropriately reviewed, including the validity of the reason for correction (whether unnatural corrections can be detected)
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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Career The profile is the information as of the time of writing.
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