Sop of Handling of out date documents

 

 

SUBJECT	STANDARD OPERATING PROCEDURE	SOP NUMBER
DEPARTMENT	QUALITY ASSURANCE & REGULATORY AFFAIRS	EFFECTIVE DATE
		REVISION NUMBER
TITLE	HANDLING OF OUT DATE DOCUMENTS	REVIEW DATE

APPROVAL LIST
	DESIGNATION	NAME	SIGNATURE	DATE
PREPARED BY
REVIEWED BY	Executive
APPROVED BY	Asst. Manager
AUTHORISED BY	General Manager

1.0 OBJECTIVE

1.1 To lay down a procedure for out date documents.

2.0 SCOPE

2.1 This procedure applies to the manufacturing facilities of pharma company

3.0 RESPONIBILITY

3.1 Executive –Quality assurance – Prepare the SOP and fallow the SOP accordingly
3.2 Manager –Quality Assurance and Regulatory Affairs -Provide the support to the
Implementation of SOP and maintained the records.

4.0 ACCOUNTABILITY

4.1 General Manager -Operation.

5.0 REFERENCE(S)

5.1 In- house.

6.0 PROCEDURE

6.1 All documents containing technical in formations must be in controlled circulation whichare

stamped in red as `Controlled copy stamped in red`
6.2 This is applicable to all-important documents like Artworks, Batch records,
Specifications and test Procedures and standard test procedure etc.
6.3 Retrieve all such outdated documents personally or by writing a memo to the
person or department where such documents are in circulation
6.4 Any document, which is out dated, must be retrieved immediately to stop its
use. If required, it must be replaced with new one at the same time.
6.5 The number of copies of such retrieved documents must be same as the
number of distribution.
6.6 Destroy all the copies, which are in distribution by tearing them and record
in the log book in the “Disposal done by” and “Disposal Date “ columns
6.7 Make entry of retrieval of document in the record.

6.8 Stamp “OBSOLETE COPY-FOR REFERENCE USE ONLY” as the case
may be,on the original copy with red ink and file it.
6.9    All controlled document will retained by as per SOP
6.10 All controlled document will dispose off by as per SOP. .

7.0 ABBREVIATIONS

The abbreviations used in the SOP are:

SOP – Standard Operating Procedur
No. – Number
QA – Quality Assurance
QC – Quality Control
NA – Not Applicable

CIRCULATION LIST
	Department	Copy No.	No. of Copies Issued	Details of copies
	Quality Assurance	1	2	Control copy for department head
	Quality Assurance	2		Display copy
	Production	3	1	Control copy for department head
	QC	4	1	Control copy for department head
	Engineering	5	1	Control copy for department head
	Warehouse	6	1	Control copy for department head
	Commercial	7	1	Control copy for department head
	Human Resource Management	8	1	Control copy for department head
	Safety, Health & Environment	9	1	Control copy for department head