Sop of Handling of out date documents
|SUBJECT||STANDARD OPERATING PROCEDURE||SOP NUMBER|
|DEPARTMENT||QUALITY ASSURANCE & REGULATORY AFFAIRS||EFFECTIVE DATE|
|TITLE||HANDLING OF OUT DATE DOCUMENTS||
|APPROVED BY||Asst. Manager|
|AUTHORISED BY||General Manager|
1.1 To lay down a procedure for out date documents.
2.1 This procedure applies to the manufacturing facilities of pharma company
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.
4.1 General Manager -Operation.
5.1 In- house.
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6.3 Retrieve all such outdated documents personally or by writing a memo to the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. .
The abbreviations used in the SOP are:
SOP – Standard Operating Procedur
No. – Number
QA – Quality Assurance
QC – Quality Control
NA – Not Applicable
|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|