sop of control and distribution of signature log


sop of control and distribution of signature log




1.1 To lay down a procedure for preparation, control and distribution of signature log so as to identify the persons who has acknowledged the documents/record.
2.0. SCOPE :
2.1 This procedure is applicable to all employees who are responsible for preparation, review and approval of documents and/or records.
3.1 QA officer/executive:
3.2 All employees shall be responsible to sign on documents/records exactly the same they have done in signature log provided by QA.

QA Head.

5.1. QA officer/executive shall take signature of new employee after completion of induction training on ‘Signature Log’ (Annex-I).
5.2. QA officer/executive shall ensure that all information required to be filled in Annex-I are hand written.
5.3. After taking signature, QA officer/executive shall control and distribute this Annex-I following minimum departments:
5.3.1. Warehouse
5.3.2. Production
5.3.3. QC
5.3.4. QA (IPQA)
5.3.5. E&M
5.3.6. P&A
5.4. QA officer/executive shall retrieve and tear off all distributed controlled copies.
5.5. QA officer/executive shall file the original copy and keep in documentation cell.
5.6. All employees shall sign on documents/records exactly the same they have done in signature log i.e. Annex-I.
5.7. If Identification of person who signed the document/record is required by any department, manager/head of that department shall compare

the sign on document/record against the available signature log.
5.8. If during self-inspection or GMP audit by external party/regulatory agency, QA Head shall ensure that original copy of signature is available.
5.9. At Interval of six months QA officer/ Executive shall revise the (inclusion or exclusion of signature) the signature log if applicable.

Sr. No. Abbreviation used Full form of abbreviation used
1. SOP Standard Operating Procedure
2. QA Quality Assurance department
3. IPQA In-Process Quality Assurance
4. E&M Engineering and Maintenance department
5. P&A Personnel and Administration department
6. GMP Good Manufacturing Practices

Annex-I : Signature Log


Sr. No. Reference Title
1.0 Quality assurance of Pharmaceuticals, A compendium of guidelines and related materials,
2.0 Guide to Good Manufacturing

Practice for Medicinal Products


Annexure 1

Signature Log



Employee Name Joining date Department Designation Full signature specimen Short signature specimen


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