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