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.