STANDARD OPERATING PROCEDURE FOR INVENTORY AND CONTROL OF DOCUMENTS

1.0 OBJECTIVE

1.1 To lay down a standard procedure to be followed for Inventory and Control of Documents.

2.0 SCOPE

2.1 This SOP shall be applicable to the inventory and control of documents in the Department of Quality assurance (QAD) and Animal House Facility (AHF).

3.0 RESPONSIBILITY

3.1 Head- QA

3.2 QA Personnel (QAP)

3.3 Head- AHF

4.0 DEFINITIONS

4.1 Nil

5.0 PROCEDURE

5.1 Control and Distribution of Documents

5.1.1 Required documents of the individual department shall be prepared by the concerned department Head / Designee.

5.1.2 Any new document prepared the first time, the respective department person shall have prepared the draft copy of the document and forward it to the QA Manager/Head for approval.

5.1.3 After making necessary changes and approval of the draft copy of the document, make the changes in soft copy and destroy the draft copy by shredding or tearing off.

5.1.4 Only the QA department is authorized to take the printouts of the documents.

5.1.5 Take the printouts of the document on A-4 size papers and send them to the respective department for signatures if any. After the final signature of “Approved By” if any, Stamp the document (including enclosures) for “MASTER COPY” in green colored ink on the bottom left-hand side of every page of the document. Original of all documents is termed as MASTER COPY.

5.1.6 Prepare only one Master Copy of all the document and keep in the QA custody.

5.1.7 Xerox Copy of ‘MASTER COPY’ shall be distributed to the user department for implementation. Such copies shall have the stamp of Controlled copy in case of SOPs in blue color at the bottom right of every page with issue stamp on the front page in blue color ink at the center of the bottom.

5.1.8 Formats shall be issued to user departments by QA after receiving a requisition in the prescribed format. QA personnel shall take a xerox of the required number of formats from its master copy and issue the same with issuance details. Formats in the unbound form shall be stamped with blue ink on the center bottom of each page with issuance details i.e. issued to, issued by, and copy number.

5.1.9 In the case of formats in bound form (logbook/format book), the issuance stamp shall be applied only on the second page in blue color ink at the center of the bottom.

5.1.10 In case of revision, the revised document shall be issued to all copyholders and an old version document shall be taken back and recorded.

5.1.11 The Original documents/Master copies of the earlier version shall have a diagonal stamp of ‘OBSOLETE’ in the center of the page in red ink and shall be kept in an archive file in the QA department.

5.1.12 If Documents shall be issued to any customer or any agency mark all pages of Xerox copies of documents with ‘UNCONTROLLED COPY’ Stamp in red color ink in the center of every page diagonally.

5.1.13 All documents will assign a unique number as per the respective department.

5.2 Numbering of Documents

5.2.1 Ø For SOP: SOP/XXX/YYY

All SOPs shall be numbered as per a unique numbering system of 11 characters where the First three characters are “SOP” which signify Standard Operating Procedure; 5th, 6th and 7th characters are “XXX” which signify department code to which SOP belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility; 4th and 8th characters are slash (/); 9th, 10th and 11th characters are “YYY” which signify SOP number starting from 001.

5.2.1.1 For example Numbering of the SOPs of the AHF Department shall be SOP/AHF/001, SOP/AHF/002…and so on.

5.2.2 Ø For Logbook: LB/XXX/YY/001

All logbooks shall be numbered as per a unique numbering system of 13 characters where 1st and 2nd characters are ‘LB’ which signify ‘Logbook’, 4th, 5th and 6th characters are ‘XXX’ which signify ‘Department Code’ to which logbook belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility; Character no. 8th and 9th are ‘YY’ which signify the last two digits of the year in which the logbook is issued; The 11th, 12th and 13th characters ‘001’ signifies the Sr. No. of logbook; Character No. 3rd, 7th, and 10th are oblique marks ‘/’.

5.2.2.1 For example Numbering of logbooks of the AHF Department for the year 2015 shall be LB/AHF/15/001, LB/AHF/15/002…and so on. When the year changes to 2016 the numbering shall start again from ‘001’ i.e. LB/AHF/16/001, LB/AHF/16/002…

5.2.3 Ø For Enclosures: X/SOP/YYY/ZZZ/**-$$

All Enclosures (Annexures/Formats) shall be numbered as per a unique numbering system of 19 characters where 1st character X signifies the type of document i.e. “A” for Annexures and “F” for Formats; 3rd, 4th and 5th characters are ‘SOP’ which signify ‘Standard Operating Procedure’; 7th,8th and 9th characters are ‘YYY’ which signify ‘Department Code’ to which format belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility, DQC for Quality Control Department; character nos. 11th, 12thand 13th are ‘ZZZ’ which signify the SOP number to which the Annexure / Format belongs; character nos. 15th and 16th are ‘**’ signifying Annexure / Format Sr. No.; Character No. 18th and 19th are ‘$$’ signifies version number; character no. 2nd, 6th,10th,14th is oblique mark ‘/’ and character no. 17th is hyphen mark ‘-’.

5.2.3.1 For example the first annexure with the first version number of the SOP No. SOP/QAD/001 is given as “A/SOP/QAD/001/01-00” and first format with the first version number of the SOP No. SOP/QAD/001 is given as “F………………..”.

5.2.4 Ø For Format book: FB/XXX/YY/001

All Format books shall be numbered as per a unique numbering system of 13 characters where 1st and 2nd characters are ‘FB’ which signify ‘Format book’; 4th, 5th and 6th characters are ‘XXX’ which signify ‘Department Code’ to which Format book belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility; Character no. 8th and 9th are ‘YY’ which signify the last two digits of the year in which the format book is issued; 11th, 12th and 13th characters are ‘001’ signifies the Sr. No. of format book; Character No. 3rd, 7th, and 10th are oblique marks ‘/’.

5.2.4.1 For example Numbering of the Format Books of Animal House Facility for the year 2015 shall be FB/AHF/15/001, FB/AHF/15/002…and so on. When the year changes to 2016 the numbering shall start again from ‘001’ i.e. FB/AHF/16/001, FB/AHF/16/002…

6.0 ENCLOSURES

6.1 Formats

Sr. No.	Format Title	Format No.	No. of pages
	Master list of Instrument	F…………………..	01
	Master list of miscellaneous articles	F…………………..	01

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

7.3 AHF- Animal House Facility

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1 Nil

                                                           END OF DOCUMENT

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