- 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
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- 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
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube