FGFGG
PROCESS / PACKING VALIDATION REPORT
PRODUCT
NAME: .............
GENERIC NAME:
Ofloxacin
& Ornidazole Tablets IP
BATCH NO.:
ISSUE DATE:
|
Sr. No. |
INDEX |
Page No. |
|
1.0 |
Report
Approval |
03 |
|
2.0 |
Document Required |
03 |
|
3.0 |
List of Machines and Equipments required in Manufacturing and Packing |
04 |
|
4.0 |
Raw Materials Required |
05 |
|
5.0 |
Packing Materials Required |
05 |
|
6.0 |
Deviation/ Failure Report |
06 |
|
7.0 |
List of attached data record form |
07 |
|
|
DATA
RECORD SHEET-1 |
07 |
|
|
DATA RECORD SHEET-2 |
08 |
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DATA RECORD SHEET-3 |
09 |
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DATA RECORD SHEET-4 |
10 |
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DATA RECORD SHEET-5 |
11 |
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DATA RECORD SHEET-6 |
12 |
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DATA RECORD SHEET-7 |
13 |
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DATA RECORD SHEET-8 |
14 |
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DATA RECORD SHEET-9 |
15 |
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DATA RECORD SHEET-10 |
16 |
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DATA RECORD SHEET-11 |
17 |
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DATA RECORD SHEET-12 |
18 |
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DATA RECORD SHEET-13 |
19 |
|
Signing of this protocol indicates agreement with the process validation report approach of Ofloxacin & Ornidazole Tablets IP. If further any changes in this protocol will be revised and duly approved. |
1.0 REPORT
APPROVAL:
|
COMPILED BY |
NAME |
DESIGNATION |
SIGNATURE & DATE |
QUALITY ASSURANCE
(Prepared By)
|
|
OFFICER QA |
|
PRODUCTION(Checked by) |
|
MANAGER-PRODUCTION |
|
|
QUALITY CONTROL (Checked by) |
|
MANAGER-QUALITY CONTROL |
|
|
QUALITY ASSURANCE (Approved by) |
|
ASST. MANAGER QUALITY ASSURANCE |
|
|
AUTHORISED BY (Plant-Head) |
|
PLANT HEAD |
|
2.0 DOCUMENTS
REQUIRED:
The following documents are required to
prepare the validation report and carry out the process Validation of Ofloxacin & Ornidazole Tablets IP.
|
SR. NO |
NAME OF
THE DOCUMENTS |
DOCUMENT
NO. |
|
1.
|
Master Formula Record
|
|
|
2.
|
Finished Product Release Specification |
|
|
3.
|
Method of Analysis |
|
|
4.
|
Batch Manufacturing Record |
|
3.0 LIST OF
MACHINES AND EQUIPMENTS REQUIRED IN MANUFACTURING:
|
Sr. No. |
Name of Equipment |
Equipment ID No. |
|
1.
|
Vibro Sifter |
|
|
2.
|
Rapid mixer granulator (RMG) |
|
|
3.
|
Paste kettle |
|
|
4.
|
Fluid bed dryer (FBD) |
|
|
5.
|
FBD Bag |
|
|
6.
|
Multi-mill |
|
|
7.
|
Octagonal blender |
|
|
8.
|
Weighing Balance 300
KG |
|
|
9.
|
SS scoop |
|
|
10.
|
Compression Machine (Forced Feeder machine) |
|
|
11.
|
Disintegration Tester |
|
|
12.
|
Friability Apparatus |
|
|
13.
|
Vernier caliper |
|
|
14.
|
Hardness Tester |
|
|
15.
|
Weighing Balance 300 gm |
|
|
16.
|
Double rotary compression machine(35 station) |
|
|
17.
|
Blister packing machine |
|
4.0 RAW
MATERIAL REQUIRED:
|
Sr. No. |
Name Of
The Ingredients& Specification |
Std Qty. (kg) |
A.R. NO |
Qty Issued |
Qty Issued
By/On |
Checked By/On |
|
1. |
Starch |
7.000 |
|
|
|
|
|
2. |
Mccp
(Micro Crystalline Cellulose) |
2.000 |
|
|
|
|
|
3. |
Starch
For Paste |
1.500 |
|
|
|
|
|
4. |
Gelatin |
0.600 |
|
|
|
|
|
5. |
Aerosil
(Colloidal Silicon Dioxide) |
0.750 |
|
|
|
|
|
6. |
Talc
Cross Carmellose Sodium |
0.750 |
|
|
|
|
|
7. |
Cross
Povidone XL-10 USP28/NF23 |
0.800 |
|
|
|
|
|
8. |
Magnesium
Stearate |
1.000 |
|
|
|
|
|
9. |
Purified
Water |
15.000 |
|
|
|
|
|
10. |
Talc |
2.000 |
|
|
|
|
|
11. |
Sodium
Starch Glycolate |
0.750 |
|
|
|
|
|
12. |
HPMC
E15 CPS (Hydroxy Propyl Methyl Cellulose) |
1.000 |
|
|
|
|
|
13. |
Colour
Titanium Dioxide |
0.100 |
|
|
|
|
|
14. |
Colour Lake Sunset Yellow |
0.300 |
|
|
|
|
|
15. |
Talc |
2.500 |
|
|
|
|
|
Active Ingredient |
Batch No. |
A.R. No. |
Assay (%) |
Water/ LOD (%) |
Mfg. Date |
Exp. Date |
Checked by |
|
|
Store |
QA |
|||||||
|
Ofloxacin |
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Ornidazole |
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|
5.0 PACKING MATERIAL REQUIRED:
|
Sr. No. |
Packing
Material |
UOM |
Standard
Qty. |
A.R. No. |
Issued By
(Store) |
Received/
Checked by (Prod/ IPQA) |
|
1
|
Printed aluminum foil |
Kg. |
03.500 |
|
|
|
|
2
|
Clear PVC |
Kg. |
16.000 |
|
|
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|
3
|
Outer Cartons (20
x1x 10’s) |
Nos. |
500 |
|
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|
4
|
Shipper (50x20x1x10’s) |
Nos. |
11 |
|
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|
5
|
BOPP tape with logo
printed. |
Rolls |
02 |
|
|
|
6.0 DEVIATION
REPORT:
6.1 DEVIATION(S)
6.2 JUSTIFICATION
FOR ACCEPTANCE:
6.3 IMPACT ON
PROCESS:
|
Supervisor Sign & Date: |
Approved By Sign & Date: |
7.0 LIST OF ATTCHED DATA RECORD FORM
DATA RECORD SHEET – 1
STAGE: SIFTING:
Date: ____ /____ /______
Batch No.:___________
RESPONSIBILITY: PRODUCTION OFFICER & QA OFFICER
TEMP________ºC (NMT 25±2°C) %RH_____________
(NMT
55±5%)
Sieve I.D. No.: _____________________.
|
Sr. No. |
Materials |
Quantity In kg |
Sieve size |
Sieve
Integrity Checked by |
Time |
Done By |
Checked By |
||
|
Before |
After |
From |
To |
||||||
|
1. |
Ofloxacin |
20.000 |
30# |
|
|
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|
|
|
|
2. |
Ornidazole |
50.000 |
30# |
|
|
|
|
|
|
|
3. |
Starch |
7.000 |
80# |
|
|
|
|
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|
|
4. |
MCCP
(Micro Crystalline Cellulose) |
2.000 |
60# |
|
|
|
|
|
|
|
5. |
Starch
for Paste |
1.500 |
80# |
|
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|
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|
6. |
Gelatin |
0.600 |
-- |
|
|
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|
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|
7. |
Aerosil
(Colloidal silicon dioxide) |
0.750 |
60# |
|
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|
8. |
Cross
Carmellose sodium |
0.750 |
60# |
|
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|
9. |
Cross
Povidone XL-10 USP28/NF23 |
0.800 |
60# |
|
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|
|
10. |
Magnesium
Stearate |
1.000 |
60# |
|
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11. |
Talc |
2.000 |
60# |
|
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|
12. |
Sodium
Starch Glycolate |
0.750 |
60# |
|
|
|
|
|
|
|
13. |
HPMC
E15 CPS(Hydroxy Propyl Methyl Cellulose) |
1.000 |
---- |
|
|
|
|
|
|
|
14. |
Colour
Titanium dioxide |
0.100 |
--- |
|
|
|
|
|
|
|
15. |
Colour Lake Sunset Yellow |
0.300 |
--- |
|
|
|
|
|
|
|
16. |
Talc |
2.500 |
60# |
|
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|
|
|
|
DATA
RECORD SHEET – 2
STAGE:
DRYING
Date: ____
/____ /______
Batch No.:___________
INSTRUCTIONS:
Analyze the samples collected at the top, middle, and
bottom after drying for Loss on drying.
Note down the results.
- Loss on Drying of Sample.
RESPONSIBILITY:
QC
Q.C. Report No.:______________
|
Moisture (%) |
Loss on Drying
(%) |
Average
(%) |
SD (%) |
RSD (NMT 5.0 %) |
|
Top
|
|
|
|
|
|
Middle |
|
|||
|
Bottom
|
|
|
Written By Sign & Date: |
Verified By Sign & Date: |
DATA
RECORD SHEET – 3
STAGE: LUBRICATION:
Date: ____
/____ /______
Batch No.:___________
INSTRUCTIONS:
1. After
blending collect the sample as per Sample
plan attached,
Responsibility:
QC, Q.A. AND PRODUCTION OFFICER
Temp.: _______ºC (NMT 25±2°C)
%RH:
________% (NMT 55±5%)
Observations: Lubrication:
- 40mints
No. of Samples (lubrication):
3 Samples from Top
TOP
X1
X 2
X 3 3
Samples from Middle
3 Samples from Bottom
X 4 X 5 X 6
MIDDLE
No. of Samples (after addition of Magnesium
Stearate):
X7 X 8 X 9 3 Samples from Middle
BOTTOM
3 Samples from
Bottom
1 Sample from Discharge Chute
Where………, X1,
X2, X3 denotes Top Left, Top Middle, and Top Right.
X4, X5, X 6
denotes Middle Left, Middle Middle and Middle Right.
OCTAGONAL BLENDER X7, X8, X 9
denotes Bottom Left, Bottom Middle, and Bottom Right.
X10 denotes discharge chute
Note: Composite sample by mixing the
samples from all sampling points.
|
Theoretical
Quantity ( Kg ) |
Actual Quantity
(Kg) |
%Loss (NMT 2.0%) |
|
|
|
|
DATA
RECORD SHEET – 4
STAGE: LUBRICATION
Date:
___/___/___
Batch No. :___________
INSTRUCTION:
Analyze the samples collected
at the top, middle & bottom and hold time for the tests given below and
note down the results.
- Assay of Ofloxacin &
Ornidazole.
- Bulk Density of Composite Sample.
- LOD of composite Sample & Hold Time Sample
RESPONSIBILITY: QC
Note- Where, M= Weight taken for measurement, V0=
unsettle apparent volume &Vf= final tapped.
|
Sample Location |
Assay of Ofloxacin (%) |
Assay of Ornidazole (%) |
Average (%) |
SD (%) |
RSD (NMT 5.0 %) |
|
TL |
|
|
Average of Ofloxacin Assay: |
|
|
|
TM |
|
|
|||
|
TR |
|
|
|||
|
ML |
|
|
|||
|
MM |
|
|
|||
|
MR |
|
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Average of Ornidazole Assay: |
|
|
|
BL |
|
|
|||
|
BM |
|
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|||
|
BR |
|
|
|||
|
CS |
|
|
Bulk Density: ___________________
Loss on drying: __________________
|
Written By Sign & Date: |
Verified By Sign & Date: |
DATA RECORD SHEET – 5
STAGE: COMPRESSION AT LOW AND HIGH SPEED
Date: ___/___/___
Batch No. :___________
INSTRUCTION:
1. Ensure
that all parameters are within specified limit.
Responsibility: QA & PRODUCTION
COMPRESSION MACHINE ID NO.:______________ BALANCE ID NO.:____________
|
Test |
Result |
Acceptance
Criteria |
|
|
Low Speed
(10 RPM) |
High Speed
(25 RPM) |
||
|
RPM: ____________ |
RPM: ____________ |
||
|
Description |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
As per BMR |
|
Thickness
(mm) |
|
|
As per BMR |
|
Min_________ Max_________ |
Min_________ Max_________ |
||
|
Hardness |
|
|
As per BMR |
|
Min_________ Max_________ |
Min_________ Max_________ |
||
|
Avg. Wt.
of 20 Tablets |
|
|
As per BMR |
|
Individual
Weight Variation |
|
|
As per BMR |
|
Min_________ Max_________ |
Min_________ Max_________ |
||
|
Friability |
|
|
As per BMR |
|
Disintegration
Time |
|
|
As per BMR |
DATA
RECORD SHEET – 6
STAGE: COMPRRESSION AT OPTIMUM SPEED
(15 RPM)
Date: ___/___/___
Batch No. :___________
INSTRUCTION:
- Ensure that all parameters are within specified limit.
- Send the sample to QC for analysis from start middle & end.
RESPONSIBILITY: QA & PRODUCTION
COMPRESSION MACHINE ID NO.:______________ BALANCE ID NO.:____________
Std. Avg. Weight of 20 tablets (Frequency: At the
start and after every 30 Minutes)
|
Date |
Time |
20 Tabs
Wt. (gm) |
Avg. Wt. (mg) |
Date |
Time |
20 Tabs
Wt. (gm) |
Avg. Wt. (mg) |
||||
|
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
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DATA
RECORD SHEET – 7
STAGE: COMPRRESSION
Date: ___/___/___
Batch No. :___________
INSTRUCTION:
- Ensure that all parameters are within specified limit.
- Record the observation at start middle & end of compression.
Responsibility: QA & PRODUCTION
|
Date: |
|
|
|
|||
|
Time: |
(Start) (_____:_______) |
(Middle) (_____:_______) |
(End) (_____:_______) |
|||
|
Side: |
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
|
Description: |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
White coloured, Elongated
Shaped, Biconvex, tablets having scored line on one side and plain other
side. |
|
Hardness: NLT 4.0 Kg/Cm2 |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
|
Max.______ |
Max.______ |
Max.______ |
Max.______ |
Max.______ |
Max.______ |
|
|
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
|
|
Thickness: 5.6 ± 0.2 mm ( 5.4 mm to 5.8 mm) |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
Min.______ |
|
Max.______ |
Max.______ |
Max.______ |
Max.______ |
Max.______ |
Max.______ |
|
|
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
Avg.______ |
|
|
Disintegration Test. (NMT 15 Minutes) |
|
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Friability Test: (NMT 1.0% w/w) |
|
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Checked By: |
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Verified By: |
|
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|
DATA RECORD SHEET – 8
STAGE: HOPPER STUDY
Date: ___/___/___
Batch No.
:___________
INSTRUCTIONS:
1. Ensure that all parameters
are within specified limit.
Responsibility:
QA &
PRODUCTION OFFICER
|
Hopper Condition |
Fully Filled
Hopper Wt.:…...Kg |
Half Filled
Hopper Wt.:…...Kg |
Last Filled
Hopper Wt.:…...Kg |
Last Filled
Hopper Wt.:…...Kg |
Last Filled
Hopper Wt.:…...Kg |
Checked
by/on |
Verified by/on |
Remark |
|||||
|
Speed ( RPM) |
Speed ( RPM) |
Speed ( RPM) |
Speed ( RPM) |
Speed ( RPM) |
|||||||||
|
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
LHS |
RHS |
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Thickness |
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Weight of tab |
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Hardness |
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Disintegration Time |
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CONCLUSION:-
DATA RECORD
SHEET – 9
STAGE: COMPRESSION
Date: ___/___/___ Batch
No. :___________
INSTRUCTIONS:
Analyze the samples
collected at the stage start, middle and end of compression for the tests given
below and note down the results.
1. Assay - as per specification
Responsibility: QC Q.C.
Report No.: ______________
Description of Tablets: - Orange
coloured, Elongated Shaped, Biconvex, film coated tablets having scored line on
one side and plain other side.
|
PARAMETER |
Start |
Middle |
End |
ANALYSED
BY/ON |
CHECKED
BY/ON |
||||
|
Min. |
Max. |
Min. |
Max. |
Min. |
Max. |
||||
|
Average Weight |
|
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Diameter |
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Thickness
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Hardness |
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Disintegration Time |
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Friability |
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STAGE Of
VALIDATION |
Assay (%) Ofloxacin |
Assay (%) Ornidazole |
Uniformity
of weight |
ANALYSED
BY/ON |
CHECKED
BY/ON |
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Min. |
Max. |
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Start |
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Middle |
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End
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Minimum |
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Maximum |
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AVERAGE |
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SD |
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% RSD
(NMT 2.0%) |
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DATA RECORD SHEET – 10
STAGE:
HOLD TIME
Date: ___/___/___
Batch No.
:___________
INSTRUCTIONS:
Analyze the samples collected at the stage of
compression for the tests given below and note down the results.
Responsibility:
QC
HOLD TIME OF BLENDER SAMPLE:
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Sample |
Description |
Assay of Ofloxacin (%) |
Assay of Ornidazole (%) |
LOD |
Tapped and Untapped Density |
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Initial |
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7th day |
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15th day |
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30th day |
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HOLD TIME OF COMPRESSED
TABLET SAMPLE:
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SAMPLE |
Description
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Hardness |
Avg. wt of
20 tablets |
D.T. Test |
Friability Test |
Assay Of Ofloxacin (%) |
Assay Of Ornidazole (%) |
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Initial |
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90th day |
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DATA RECORD SHEET – 11
STAGE:
BLISTER PACKING:
Temp.: _______ºC (NMT 25±2°C)
%RH:
________% (NMT 55±5%)
INSTRUCTION:
1. Collect sample during
blister packing at the high, low & optimum RPM and check leak test
performance & printing Quality.
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Speed (RPM) |
Leak Test Performance |
Printing Quality |
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Low
(RPM……………..) |
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High
(RPM……………) |
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Optimum
(RPM………….) |
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CONCLUSION:-
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Written By Sign & Date: |
Verified By Sign & Date: |
DATA RECORD SHEET – 12
OVERPRINTING & PACKING PROCESS: (OVERPRINTING MACHINE
I.D.NO.: __________________)
Date: ___/___/___ Batch
No. :___________
Temp.: _______ºC (NMT 25±2°C)
%RH: ________% (NMT 55±5%)
INSTRUCTION:
- Check the overprinting details and suitability
for label, cartons and shippers, record the observation in the below given
table.
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Sr. No. |
Packing Stage |
Test |
Acceptance
criteria |
Observation (Ok / Not Ok) |
Checked by/on |
Verified by/on |
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1. |
Overprinting Quality |
1. Overprinting details 2. Pasting of Carton |
1. Overprinting should be
Legible. 2. Should be fixed properly. |
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After getting line clearance
by QA for finished product Start the packing activity as per SOP
In process parameter of Packing Process:-
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Sr. No. |
Parameters |
Acceptance Limit |
Observation |
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1. |
Appearance |
As per
BPR |
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2.
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Sealing roller Temperature |
Limit: 175 to 190°C |
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3.
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Machine Speed |
40 pack/min. |
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4. |
Leak Test |
To comply
as mentioned in BPR |
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5. |
Taping |
Shape & Printing Detail. |
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Done By (Sign/date): |
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Verified By (Sign/date): |
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DATA RECORD SHEET – 13
STAGE: FINISH PRODUCTS:
Date: ___/___/___
Batch
No. :___________
INSTRUCTION:
Ensure that all parameters
are within specified limit.
- Assay - as
per specification
Responsibility: QC
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Sr. No. |
TEST PARAMETER |
ACCEPTANCE
LIMIT |
START |
MIDDLE |
END |
AVERAGE |
SD
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%
RSD (NMT 5.0%) |
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Average Wt.(mg) |
Limit: 850.0 mg ± 5.0 %
(807.5 mg to 892.5 mg)
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Thickness (mm) |
5.6 ± 0.2 mm (
5.4 mm to 5.8 mm) |
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Hardness (Kg/cm2) |
NLT 4.0 Kg/cm2 |
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Disintegration Time (min) |
NMT 30 min. |
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Friability (%w/w) |
NMT 1 % w/w |
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Uniformity of Weight |
Limit: 850.0 mg ± 5.0 %
(807.5 mg to 892.5 mg)
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Assay of
Ofloxacin |
NLT 90.0%
& NMT 110.0% |
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Assay of
Ornidazole |
NLT 90.0% & NMT 110.0% |
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ANALYSED BY Sign & Date: |
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CHECKED BY Sign & Date: |
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MICROBIAL
LIMIT TEST: (COMPOSITE SAMPLE)
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Test: |
Total
bacterial Count |
Total
fungal Count |
E. coli |
Salmonella
enterica |
P.aeruginosa
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S. aureus
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Checked
By/on
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Acceptance Criteria |
Less than 10cfu per gm |
Less than 10cfu per gm |
Absent per gm |
Absent per 10gm |
Absent per gm |
Absent per gm |
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Observation |
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8.0
STABILITY STUDY:
The samples of all the three validation batches should be subjected to
long term and accelerated stability and a protocol and report should be
documented. Attach Finished Product report along with the validation report
Conditions and Frequency
Conditions Frequency
A) At 30 ± 2°C temperature 0, 3, 6, 9,
12, 18, 24, 36 months
And 75 ± 5% Relative humidity
B) At
40 ± 2°C temperature 0, 1, 3, 6
months
And 75 ± 5% Relative humidity
9.0
CHANGE CONTROL:
Any changes from the protocol related to manufacturing process, raw
materials, equipment’s used, sampling, in-process controls and analytical
methods should be authorized and documented in the change control document. All
the change control documents should be authorized by Quality Assurance. A
record of any proposed change should be kept detailing
1.1 Present status
1.2 Detail of the Proposed
Change
1.3 The reason for a change
being required
1.4 Any Required further
consequential change
1.5 Approval change
10.0
DEVIATION:
Any deviations from the protocol related to manufacturing process, raw
materials, equipment’s used, sampling, in-process controls and analytical
methods should be authorized and documented in the batch manufacturing record
as well as the validation report
11.0
CONCLUSION:
Based on the results of all the 3
validation batches, suitable conclusions will be drawn with respect to the
suitability of proposed method of manufacture for Ofloxacin & Ornidazole Tablets
IP. Conclusion about the suitability of the
validation batches for stability testing would be drawn.
END
OF DOCUMENT
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Pharmaceutical guideline only