Friday, November 19, 2010

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.
Ø       SOPs.
o       Production
o       Stores
o       Engineering
o       Quality Control
o       Quality Assurance
o       Microbiology
o       Personnel & Administration
Ø       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
Ø       Instrument Calibration worksheets
Ø       Instrument / Equipment use logbooks.
Ø       DM Water worksheet.
Ø       HPLC / GC analysis worksheet.
Ø       Validation Protocols (Process validation, analytical method validation etc.)
Ø       Qualification Protocols (IQ/OQ/PQ)
Ø       Batch Manufacturing Record issuance intimation.
Ø       Batch Manufacturing Records
Ø       Batch Manufacturing worksheets.
Ø       Other recording formats and registers.

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





6.0      Reference Document:
·        Document issuance logbook


LOG BOOK FOR DOCUMENT ISSUANCE
               
Sr. No.
Date
Name of Document
Issued
Received
Archived
Remarks
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. No.
Previous
Revision No.
New
Rev. No.
Review Date
Reason For
Review
Change
Control
No.
Approved
By





















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