- Objective:To lay down the procedure to record the specimen signature.
- Scope:This Standard Operating Procedure is applicable for recording of specimen signature of all the personnel working at Pharmaceutical Company.
- Concerned personnel of all department shall be responsible for following the procedure written in the SOP.
- QA officer (Documentation Cell) or his/her designee shall be responsible for maintaining the record of specimen signature.
- QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
- SOP : Standard Operating Procedure
Tetracycline hydrochloride I.P. 500 mg (drugsformulations.com)
- Specimen signature is a signature of an employee of proof authenticity & identity of a person who is signing the documents.
- Specimen signature shall provide documentary evidence for signing the particular documents and performing particular jobs.
- Specimen signature shall provide a traceability of the documents signed by that particular personnel.
- Specimen signature of each & every personnel, who is responsible for signing the documents, shall be maintained.
- QA officer (Documentation Cell) or his/ her designee/nominee shall maintain the record of the specimen signatures in the Signature Log (As per Annexure –I).
- The Signature Log shall be updated when new employees are hired.
- The specimen signatures shall be recorded as full signatures and short signatures against “SIGNATURE” and “INITIAL” columns respectively.
- For any person who practices single signature, the same signature shall be recorded in both the columns.
- The concern department / section – head shall check the initial / full signature of his department personnel and same shall be submitted to QA department.
- Employee shall not change the specimen signatures during the signing of the documents.
- When any employee join/resigns/transfer to other location. Detail shall be mention in the remark column and records shall be updated accordingly.
- As a matter of policy “Signature Log” is reviewed every year.
- Forms and Records (Annexures)
- Signature Log – Annexure-I
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering & Human Resource
|Date||Revision Number||Reason for Revision|
Department/ Section: _____________________________________