sop of control and distribution of signature log

 

 

 

1.0 OBJECTIVE :
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.
3.0. RESPONSIBILITY :
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.
4.0. ACCOUNTABILITY:

QA Head.



5.0 PROCEDURE :
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.
6.0. ABBREVIATION :

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

7.0. ATTACHMENTS (ANNEXES) :
Annex-I : Signature Log

8.0. REFERENCE :

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

Sr. No.	Employee Name	Joining date	Department	Designation	Full signature specimen	Short signature specimen