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Issuance of Documents

This document provides a procedure for issuing documents from the Quality Assurance department, including SOPs, specifications, test methods, worksheets, validation and qualification protocols, batch records, and other formats. The QA department photocopies documents from the master copy, stamps them as controlled copies, signs and dates them, logs the issuance, and issues copies to the relevant departments with signatures. A log book tracks the document issuance details.

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Ashok Kumar
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504 views2 pages

Issuance of Documents

This document provides a procedure for issuing documents from the Quality Assurance department, including SOPs, specifications, test methods, worksheets, validation and qualification protocols, batch records, and other formats. The QA department photocopies documents from the master copy, stamps them as controlled copies, signs and dates them, logs the issuance, and issues copies to the relevant departments with signatures. A log book tracks the document issuance details.

Uploaded by

Ashok Kumar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Issuance of Documents.

1.0 Purpose: To provide instruction for Issuance of Documents.

2.0 Objective: To provide a documented procedure for Issuance of Documents.

3.0 Scope: This procedure is applicable for Issuance of Documents

4.0 Responsibility:
 Primary: Officer – QA

5.0 Procedure:
 The following documents shall be issued by Quality Assurance Department.
 SOPs.
o Production
o Stores
o Engineering
o Quality Control
o Quality Assurance
o Microbiology
o Personnel & Administration
 Specifications, Test Methods and Worksheets
o Raw materials
o Packing materials
o In-process and Intermediates
o Finished products
o General Test procedures
o Microbiology
 Instrument Calibration worksheets
 Instrument / Equipment use logbooks.
 DM Water worksheet.
 HPLC / GC analysis worksheet.
 Validation Protocols (Process validation, analytical method validation etc.)
 Qualification Protocols (IQ/OQ/PQ)
 Batch Manufacturing Record issuance intimation.
 Batch Manufacturing Records
 Batch Manufacturing worksheets.
 Other recording formats and registers.

 Issuance Procedure.
 Quality Assurance department shall photocopy the required copies from master copy of respected document.
 Stamp the photocopies as “CONTROLLED COPY” using Black Inkpad.
 Sign and date to control copy with Green Ink.
 Enter the issuance information in document issue register.
 Issue the copies to concern department with receiving signature.
6.0 Reference Document:
 Document issuance logbook

LOG BOOK FOR DOCUMENT ISSUANCE

Sr. Name of Issued Received Archived


Date Remarks
No. Document By Date By Date By Date

7.0 Abbreviations:
 QA = Quality Assurance department
 SOP = Standard Operating Procedure
 QC = Quality Control
 IQ = Installation Qualification
 OQ = Operation Qualification
 PQ = Performance Qualification

8.0 Copies to Distribution Sites :


 QA –
 QC-
 Stores –
 Production –
 Engineering –
 Personnel & Administration –

9.0 Review History

Sr. Previous New Review Reason For Change Approved


No. Revision Rev. No. Date Review Control By
No. No.

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