Follow
Objective: To describe the procedure for maintaining signature log of all personnel working in GMP related activities.
Scope: This SOP is applicable for all department personnel working in (Company Name).
Responsibility:
1. Concerned department shall be responsible for preparation and timely updating signature log
2. QA shall be responsible for effective implementation of the procedure
Accountability: Head of Quality
Precautions: NA
Procedure:
1. All personnel working in (Company Name) shall maintain the record of their activity and sign the record.
2. They shall be identified by their initials or signature.
3. Concerned department shall prepare the signature log for their department as per Annexure – I.
4. All employees / staff shall sign and initial in the signature log and the same signature to be used in every document for signing. The dating to be DD.MM.YY. For example a date in 7th July 2010 will be as 07.07.10.
5. All employees / staff shall maintain same signature and initial in quality documents such as Batch Manufacturing Record (BMR)/ Batch Packing Record (BPR)/ Logbooks and other GMP documents after getting appropriate training. Only appropriately trained personnel can sign in batch production records and other GMP documents.
6. Ink used for data entries, signature and initial as per procedure (SOP No.: QA028).
7. After each signature and initial the date of sign shall also be given.
8. Concern department shall update the signature log when a new person is joined.
9. Concern department shall review and update the signature log on year basis.
