Professional Documents
Culture Documents
Doc # AP-12-1035
Issue # 07
Page 1 of 18
ASSIGNEE
NAME
TITLE
PREPARED BY
MOHAMED GHAZALY
S.QA OFFICER
REVIEWED BY
MOHAMED EL-SAADY
QA Supervisor
APPROVED BY
AHMED SALAH
QA MANAGER
SIGN./DATE
HISTORY OF CHANGE
ISSUE #
ISSUE DATE
PAGE #
Issue 001to
Issue 002
31/01/2000
8&9
Issue 002 to
Issue 003
06/01/02
All pages
Issue 003 to
Issue 004
11/05/03
2
3
6
7
8-34
Issue 004 to
Issue 005
31/08/2004
1,
7
18/07/2005
All pages
15/10/2006
All pages
Issue 005 to
Issue 06
Issue 06 to
Issue 07
SUMMARY OF CHANGE
1. Change in items of release procedures.
2. Adding four attachments of checklists to be
used in the batch evaluation for release
1. Change the document title.
2. Change the scope
3. Change the responsibility
4. Change the procedures.
5. Change the attachments
1.
2.
3.
4.
5.
T3A INDUSTRIAL
Doc # AP-12-1035
ISSUE #
ISSUE DATE
Issue # 07
PAGE #
Page 2 of 18
SUMMARY OF CHANGE
4.
5.
6.
7.
8.
9.
1. OBJECTIVE:
1.1.
To establish the issuing, handling and reviewing of batch file before final release of
finished products.
2. SCOPE:
2.1.
3. RESPONSIBILITY:
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.9.
3.10.
3.11.
3.12.
3.13.
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T3A INDUSTRIAL
Doc # AP-12-1035
4.
Issue # 07
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PROCEDURE:
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 4 of 18
4.9.13.In case of adding recovered materials to the batch under processing, the batch number
of these materials shall be recorded.
4.9.14.Review the environmental data printouts, for conformance to the specific
environmental conditions required for each process for a particular product.
4.9.15.Check catalogue (or samples) of printed packaging materials to ensure that: All preprinted data are clear and correctly positioned. All printed data (e.g. Mfg. & Exp.
dates etc...) are correct, stable, clearly visible and in the correct place.
4.9.16.Ensure that the processing & packaging in-process controls are done as specified in
due time and covering all processing times (all shifts).
4.9.17.Reviewing quality control testing records ( Physical, chemical and microbiology)
4.9.17.1.Check the QC release for intermediate, semi-finished and finished products (as
indicated in the analysis request) prior to proceeding for further revisions.
4.9.18.QC department responsible for archiving the following documents: Analysis package
and prints out (Chromatograms, Spectrumetc) and environmental monitoring
reports.
4.9.19.The batch records shall be retained for one year after the expiry date of the batch and
at least 5 years after the certification.
5.
5.1.
5.2.
5.3.
5.4.
ATTACHMENT:
Batch record follow up logbook
Batch file final reviewing checklist for sterile products
Batch file final reviewing checklist for solids
Batch file final reviewing checklist for semi-solids and liquids
______________________________________________________________________________________________
PREPARED BY: REVIEWED BY: ... APPROVED BY: ..
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Batch Number
Production
Sign/ Date
BPR
BPKR
BPR
QA
Sign/ Date
Production
Sign/ Date
BPKR
BPR
BPKR
BPR
QA
Sign/ Date
BPKR
QC Sign/ Date
Decision
Page 5 of 18
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 6 of 18
QA
BPR Reviewed by
BPKR Reviewed by
Final Decision
Location
Page (
) of
_______________________________________________________________________________________________________________
PREPARED BY:
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APPROVED BY: ..
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 7 of 18
5.2. Batch file final reviewing checklist for Sterile products: (Format Unique # 0047)
Product Name:
Batch #:
Document name
Availability
Remarks
(General common documents for processing)
Processing order (or a copy)
All pages of BPR are completed
and stamped
Cleaning labels
Processing labels
Dispensing labels
A copy of rejection form ( if any)
A copy of Return order ( if any)
Material request
Print out of tunnel
Deviation report (if any)
Print out of autoclave
Load description of autoclave
Page 1 of 4
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T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 8 of 18
Product Name:
Batch # :
(Packaging documents for Vials)
(LMMOHExportExport FMS FMS Other ..)
(packaging documents for vials)
Availability
Remarks
A copy of packaging order.
All pages of BPkR are completed and stamped.
Cleaning labels
Processing labels
Weighing center labels.
A copy of rejection order (if any).
A copy of return order) if any).
A copy of material request (if any).
Deviation report (If any)
A copy of finished product delivery order.
Attached signed overprinted boxes.
Attached signed folded pamphlets.
Attached signed specimen of overprinted labels.
Page 2 of 4
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Product Name:
Theoretical batch size :
Manufacturing date:
Manufacturing started on:
Packaging Started on :
Using the last update approved document :
Presence of QC certificate of analysis :
Page 9 of 18
Batch Number:
Actual batch size:
Expiry date:
Manufacturing ended on :
Packaging ended on :
Logical sequence of processing/packaging dates :
Comments: ............................................................................................................................................................................
............................................................................................................................................................................
Page 3 of 4
Material
received
produced
Loss %
Vials
Rubbers
powder
Filled Vials
Caps
Pamphlets
Labels
Boxes
.
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T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
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.
Reviewed by: Sign/ date
Remarks for packaging section:
.
.
.
Reply of the department:
.
.
.
Reviewed by: Sign/ date
Remarks for Quality Control:
.
.
.
Reply of the department:
.
Reviewed by: Sign/ date
QA Comment:
......
...
Conclusion:
the Batch Manufacturing Records are (not) complying with GMP regulations.
The batch is (not) released for sale.
The batch records are reviewed by
QA supervisor
........
Page 4 of 4
5.3. Batch file final reviewing checklist for Solids: (Format Unique # 0048)
Product Name:
Document name
(General common documents)
Batch #:
Availability
Remarks
______________________________________________________________________________________________
PREPARED BY: REVIEWED BY: ... APPROVED BY: ..
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
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______________________________________________________________________________________________
PREPARED BY: REVIEWED BY: ... APPROVED BY: ..
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 12 of 18
Product Name:
Batch # :
(Packaging documents for solids)
(LMMOHExport Export FMS FMS Other )
Avail
(packaging documents for solids)
Remarks
ability
A copy of packaging order.
All pages of BPkR are complete and stamped.
Cleaning labels
Processing labels
Weighing centre labels.
A copy of material request (if any).
A copy of return order) if any).
Deviation report (if any).
A copy of rejection order (if any).
A copy of finished product delivery order.
Attached specimen of Alu. Foil from each reel
used in the blistering.
Attached signed overprinted boxes.
Attached signed folded pamphlets.
Attached signed specimen of overprinted labels.
Page 2 of 4
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 13 of 18
Product Name :
Batch Number :
Manufacturing date :
Expiry date :
Manufacturing started on :
Manufacturing ended on :
Packaging Started on :
Packaging ended on :
Material
received
produced
Loss %
Starting material
Capsules
Bulk product
Bottles
Cap
Pamphlets
PVC / PVDC
Labels
Boxes
AL foil
Dossier
Comments: ............................................................................................................................................................................
............................................................................................................................................................................
Page 3 of 4
Remarks for processing section:
.
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T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 14 of 18
.
Reply of the department:
.
.
Reviewed by: Sign/ date
Remarks for packaging section:
.
.
.
Reply of the department:
.
.
.
Reviewed by: Sign/ date
Remarks for Quality Control:
.
.
.
Reply of the department:
.
Reviewed by: Sign/ date
QA Comment:
......
...
..
Conclusion:
the Batch Manufacturing Records are (not) complying with GMP regulations.
The batch is (not) released for sale.
The batch records are reviewed by
QA supervisor
........
Page 4 of 4
5.4. Batch file final reviewing checklist for Semi-Solids and Liquids: (Format Unique # 0049)
______________________________________________________________________________________________
PREPARED BY: REVIEWED BY: ... APPROVED BY: ..
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Product Name:
Document name
Page 15 of 18
Batch #:
Availability
Remarks
______________________________________________________________________________________________
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T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 16 of 18
Product Name :
(Packaging documents for semi-solids and Liquids)
(packaging documents for semi-solids)
Batch # :
(LMMOHExportExport FMS FMSOther
.)
Availability
Remarks
T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 17 of 18
Product Name :
Batch Number :
Manufacturing date :
Expiry date :
Manufacturing started on :
Manufacturing ended on :
Packaging Started on :
Packaging ended on :
Material
received
produced
Loss %
Starting material
Bulk product
Filled [Bottle/tube]
Tubes
Bottles
Dossier
Cap
Pamphlets
Labels
Boxes
Comments:
.....................................................................................................................................................................................
.....................................................................................................................................................................................
Page 3 of 4
Remarks for processing section:
.
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T3A INDUSTRIAL
Doc # AP-12-1035
Issue # 07
Page 18 of 18
.
Reply of the department:
.
.
Reviewed by: Sign/ date
Remarks for packaging section:
.
.
.
Reply of the department:
.
.
.
Reviewed by: Sign/ date
Remarks for Quality Control:
.
.
.
Reply of the department:
.
Reviewed by: Sign/ date
QA Comment:
......................................
...
..
Conclusion:
The Batch Manufacturing Records are (not) complying with GMP regulations.
The batch is (not) released for sale.
The batch records are reviewed by
QA supervisor
Quality Assurance manager
........
Page 4 of 4
______________________________________________________________________________________________
PREPARED BY: REVIEWED BY: ... APPROVED BY: ..