Follow
Below mentioned requirements should be applied to all the GMP documentation within the GMP environment.
A. Clearly written documentation:
● All documents must be accurate and written in a manner that prevents errors and ensures consistency.
● If documents are to be used together, e.g. a SOP and a form, then each should reference the other.
● Ensure there is traceability between two or more documents/records using formal document numbers or record identification.
B. Using indelible ink:
● All records must be filled out in indelible BLACK or BLUE ballpoint pen for long-term legibility.
● Do not use pencil or ink that can be erased.
C. Legible handwritten Entries:
● A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All entries must be made at the time the tasks are performed and should be legibly signed and dated.
● The same is true for electronic documents and records – language should be clear and unambiguous.
D. Reviewing and approving:
● To ensure that the information is correct and accurate, documents and records should be reviewed by someone who has performed the task and has the proper knowledge. A signature and date by the reviewer/approver confirm that a review has taken place.
● Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task
E. Employee signatures:
● Handwritten signatures must be unique to the individual and listed within the signature register to ensure that the signature is traceable to the concerned employee (or contractor).
● Any employee should not be permitted to sign for another member of staff unless delegated. Signatures must never be forged.
● The management of the signature record should be governed by a procedure and routinely reviewed so that it remains current – the new employee should sign the signature register during induction, the signature register must indicate the date employee exit.
