What are the best practices for correcting GMP documentation errors?

1 Why correct GMP documentation errors?

Correcting GMP documentation errors is not only a regulatory requirement, but also a good quality management practice. It helps to prevent recurrence of errors, identify root causes of deviations, improve processes and procedures, and maintain the accuracy and reliability of the records. Moreover, it demonstrates the commitment and accountability of the personnel involved in the documentation process, and enhances the credibility and reputation of the organization.

2 How to correct GMP documentation errors?

Correcting GMP documentation errors requires clarity, legibility and transparency, with the date, time, reason and signature of the person making the correction included. Depending on the type and format of the document, there are various methods for correcting GMP documentation errors. Handwritten documents should have a single line struck through the error, with the correction written above or next to it and initialed and dated. Electronic documents should use an audit trail function or create a new version with a reference to the previous version. Printed documents should use a label or sticker to indicate the correction and attach a copy of the original document with the error marked. It is important not to overwrite, erase, disable, alter or modify the original entry.

3 When to correct GMP documentation errors?

GMP documentation errors should be corrected as soon as possible after they are detected, preferably by the person who made the error or by a supervisor. The correction should be done before the document is reviewed, approved or submitted to the next step in the process. If the error is discovered after the document has been finalized or archived, a formal change control procedure should be followed to correct the error and document the impact and justification of the change.

4 Who can correct GMP documentation errors?

GMP documentation errors can be corrected by the person who made the error or by a supervisor who has the authority and responsibility for the document. The person making the correction should have the appropriate training, qualification and experience to perform the task. The correction should also be verified and approved by another person who is independent and competent to review the document. The roles and responsibilities of the personnel involved in correcting GMP documentation errors should be defined and documented in the quality system.

5 What to do after correcting GMP documentation errors?

After correcting GMP documentation errors, the document should be checked for completeness, accuracy and consistency with other related documents. The document should also be stored and archived securely and systematically, according to the retention and disposal policies. Additionally, the root cause and impact of the error should be investigated and analyzed, and corrective and preventive actions (CAPA) should be implemented and monitored to prevent recurrence of similar errors and improve the quality of the documentation process.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?