sop for issue and retrieval of filled documents
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for issuance and retrieval of filled documents.
2.0 SCOPE
2.1 This SOP is applicable for issuance and retrieval of filled documents
3.0 RESPONSIBILITY
3.1 Asst. Officer or above QA / Executive – Concerned Department
4.0 ACCOUNTABILITY
4.1 Head – Concerned Department / Quality Assurance
5.0 REFERENCE(S)
5.1 In-House
6.0 PROCEDURE:
6.1 All completed documents such as completed master document, batch manufacturing record, Quality control data sheet, filled logbooks & registers etc. must be stored under lock and key with restricted entry of authorized person of Quality assurance only.
6.2 Issuance of filled documents shall be done only after receiving approved written requisition from the Head of concerned department and Head – Quality assurance as per Format
6.3 Issuance & retrieval details shall be recorded in Issuance and Retrieval Record of Filled/Master Documents as per Format while issuing and receiving of any filled/master document.
6.4 On receiving back the documents from the concerned department complete the entries of receiving & sign in received column along with date in Issuance and Retrieval Record of Filled/Master Documents as per Format
6.5 Archive the documents in Quality assurance record room.
7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
ANNEXURE-I
REQUISITION FOR ISSUANCE OF FILLED MASTER DOCUMENTS
Date __________
Name of the document: _______________
Product name : _______________
Batch No : ________________
Purpose of requisition: _________________________________________________________________________________________
| Name | Designation / Department | Sign | Date | |
| Requested by
(Head-Concerned Dept.) |
||||
| Approved by
(Head-QA) |