FDA cGMP regulations require all document entries to include the identity of the person(s) making the entries. Seems straightforward, doesn’t it? But what does it really mean when an employee signs or initials that document?
Generally speaking, when signing your name to or initialing a GMP document, you:
- Confirm your unique identity; and
- State that you have the authorization to perform, verify, check, review or approve the activity associated with your name.
Any good documentation practices (GDP) training should include the following key points:
- Everyone who signs controlled documentation must register their signature and initials according to company procedure. This allows unique identification of a person performing or supervising a specific GMP activity. Employees must always sign or initial documents exactly as they registered. And signatures and initials need to be updated when names change due to marriage, divorce or other reasons.
- A signature or initialing cannot be taken back. Once an employee has placed his or her name on a manufacturing document, he or she is personally, professionally and legally responsible for the action being documented.
- It is imperative that employees maintain strict control over the use of their signatures and initials. Sign and initial only for yourself. Never allow someone else to sign or initial for you unless that person has written authorization to do so and the proxy signing follows established procedure.