I.
PURPOSE
To describe
the procedure for document control.
II.
SCOPE
This
procedure is applicable to all the Quality related documents generated in
Quality Assurance,
III.
RESPONSIBILITY
User
department, QA department
IV.
ACCOUNTABILITY
Head - QA
V.
PROCEDURE
1.0 Controlled
document
Any written information,
instruction, or format approved by the Quality Assurance department.
2.0 Area of document control
2.1 Execution
of the approved current written instructions and policies.
2.2 Recording
the data of operations in the approved format.
2.3 Usage
of formats through controlled issuance.
2.4 Revision,
distribution and destruction of documents.
3.0 List of controlled documents
3.1 Standard
Operating Procedures (SOPs)
3.2 Calibration Procedures (CPs)
3.3 General
Testing Procedures (GTPs)
3.4 Batch
Production and Control Records (BPCRs)
3.5 Validation procedures (VPs)
3.6 Site
Master File (SMF)
3.7 Test
Protocols (Worksheets and COAs)
3.8 Stability
Protocols
3.9 Validation Protocols (VPs)
3.10
Qualification Protocols
3.11
Validation Master Plan (VMP)
3.12
Specifications and Testing Procedures of Raw material,
Packaging Material,
Inprocess, Intermediate, and Finished products.
3.13
Formats used in documentations.
3.14
Drawings and layouts.
4.0 Before
issuing the documents for review, QA stamps the “DRAFT FOR REVIEW”
and “REVIEWED BY ” and
issues to the concerned department.
5.0 Persons who reviewed the document must
sign under the “REVIEWED BY”.
6.0 After review, master documents should be
taken on A4 size executive bond paper with Aurobindo logo.
7.0 Original documents are stamped as “MASTER
COPY” and archived in QA
department.
6.0 Distribution of documents
6.1 Specimen
stamps should be as per the Annexure No.: AX01/SOPQA005-00.
6.2 Photocopies
of the “MASTER COPY” should be stamped and issued as follows
|
Stamp Name
|
Issued to
|
Location of stamping
|
|
“CONTROLLED COPY”
(Green colour)
|
User Dept.
|
Bottom right side
|
|
“REFERENCE COPY”
(Red colour)
|
Work Place of user Dept.
|
Bottom right side
|
|
“UNCONTROLLED COPY”
(Blue colour)
|
Outside of
Unit – V
|
Bottom right side
|
|
“OBSOLETE COPY ”
(Red colour)
|
To be archived in QA dept.
|
Across the text
|
|
“MASTER COPY”
( Red colour)
|
To be archived in QA dept.
|
Top left side
|
|
“DRAFT FOR REVIEW”
(Red colour)
|
User Dept.
|
Across the text
|
|
“REVIEWED BY”
(Blue colour)
|
User Dept.
|
Right side middle
|
|
'QA SEAL'
|
User Dept.
|
Bottom right side
|
|
Prepared by
Checked by
Approved by
(Blue colour)
|
QA Dept
|
Back side centre
|
7.0 Storage
of Formats
7.1
QA should keep one set of 'MASTER COPY'
separately for all the formats and check and approve them.
7.2 After approval, take out photo
copies of the formats and stamp them with Prepared by,
Reviewed by , Approved by stamp as given in the table on the back sidecentre
approved formats under lock and key.
7.3 If
the SOP is revised, destroy the previous version of the format and replace
it with
the current approved format.
8
Issue of Formats
8.1
User department sends the ‘Format
requisition’
Format No.: F01/SOPQA005- 00 as per the requirement.
8.2
QA verifies the requirement, and
issues the formats by stamping ‘Issued by, Sign
&Dt’ on first page and ‘QA SEAL’ on all the pages.
8.3 If the formats are issued in the form of
books, QA should enter the issue details in ‘Book
issuance format’ as per the Format No.: F02/SOPQA005-00, which is the first page of the book.
8.4
QA should record the issuance
details in ‘Format Issuance Record’as per the
Format
No.: F03/SOPQA005-00.
9
Archival of
documents
9.1 QA department must have a document storage
facility to archive the following
documents:
9.1.1
Master copy of all documents.
9.1.2
Executed BPCR along with QC test protocols.
9.1.3
Validation reports.
9.1.4
Executed Qualification protocols.
9.1.5
Obsolete Documents.
9.2 Only authorized persons must enter the
document storage room.
9.3 Store
the documents in the documentation room under lock and key.
10 Revision of Documents
10.1
Revise all the documents as per their prescribed
review period or as and when
required, Document revision shall
be controlled through Change Control
Procedure.
10.2
If the document is revised, stamp the previous version
of Master Copies as
“OBSOLETE
COPY”.
10.3
Retrieve all the previous documents before issuing the
new version documents.
10.4
Destroy all the retrieved Controlled /Reference
copies.
10.5
After completion of storage period, that is 1 year
after expiry period of the
product,
destroy all the retained documents either by shredding or by
incineration.
10.6
The following documents should not be destroyed even
after expiry date.
10.6.1
Obsolete
documents.
10.6.2
Documents which are submitted to regulatory authorities.
10.6.3
Validation protocol reports.
10.6.4
Qualification protocols.
11 List of Formats
|
Format No.
|
Title
|
|
F01/SOPQA005-00
|
Format
requisition
|
|
F02/SOPQA005-00
|
Book
issuance format
|
|
F03/SOPQA005-00
|
Format
issuance record
|
12 List of
Annexures
|
Annexure No.
|
Title
|
|
AX01/SOPQA005-00
|
Specimen stamps
|
VI. REVISION
SUMMARY
|
Version No.
|
Revised on
|
Reason for Revision |
|
00
|
NA
|
NA |
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