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Kiran KumarCopyright:
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ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 1 of 10
Effective date Vial Fill Volume
SAMPLING SCHEDULE
1.0. Compounding
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
A clear, colorless
Description and odorless
liquid
pH Between 5.0 – 7.0
Compounding
A NMT 1.3µs/cm
WFI Conductivity
Not more than
BET
0.25 EU/mL
A. R. Number
Done By ( Sign & Date )
B1 Bio burden 1 CFU / 100 mL
Description
After pH
Compounding
B2 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 2 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
B3 Bio burden 1 CFU / 100 mL
Description
After pH
Compounding
( 24 Hours ) B4 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
B5 Bio burden 1 CFU / 100 mL
Description
After pH
Compounding
( 36 Hours ) B6 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
B7 Bio burden 1 CFU / 100 mL
Description
After pH
Compounding
( 48 Hours ) B8 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 3 of 10
Effective date Vial Fill Volume
2.0. Filtration
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
C1 Bio burden 1 CFU / 100 mL
Description
Filter Flush pH
C2 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
3.0. Filling
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 4 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
D1 Bio burden 1 CFU / 100 mL
Description
pH
First Stroke
D2 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D3 Bio burden 1 CFU / 100 mL
Description
pH
Second Stroke
D4 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D5 Bio burden 1 CFU / 100 mL
Description
pH
Third Stroke
D6 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 5 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
Description
Not less than
90.0% and not
Content
Filling and more than 110.0%
D7 uniformity
Stoppering of the labeled
Initial amount
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
Not less than
90.0% and not
Content
more than 110.0%
Filling and uniformity
of the labeled
Stoppering D8
amount
Middle
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
Not less than
90.0% and not
Content
Filling and more than 110.0%
uniformity
Stoppering D9 of the labeled
(End) amount
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 6 of 10
Effective date Vial Fill Volume
4.0. Hold Time Studies
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D10 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D11
(8 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D12 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(12 Hours) D13
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D14 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D15
(18 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D16 Sterility No Growth
Description
pH
After Secondary
filtration D17 Not less than
(24 Hours) 95.0% and not
Assay
more than
105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 7 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D18 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D19
(32 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D20 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(40 Hours) D21
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D22 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D23
(48 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D24 Sterility No Growth
Description
pH
After Secondary
filtration D25 Not less than
(56 Hours) 95.0% and not
Assay
more than
105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 8 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D26 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D27
(64 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D28 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(72 Hours) D29
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 9 of 10
Effective date Vial Fill Volume
5.0. Seal integrity / Leak test
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
Seal integrity / Should pass seal
Sealing Leak test integrity test
E1
(Initial)
A. R. Number
Done By ( Sign & Date )
Seal integrity / Should pass seal
Sealing Leak test integrity test
E2
(Middle)
A. R. Number
Done By ( Sign & Date )
Seal integrity / Should pass seal
Sealing Leak test integrity test
E3
(End)
A. R. Number
Done By ( Sign & Date )
6.0. Finished Samples
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
As per FP As per FP
Optical Specification Specification
H
inspection
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 10 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
B1 Bio burden 1 CFU / 100 mL
Description
pH
B2 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 11 of 10
Effective date Vial Fill Volume
7.0. Filtration
1 st Batch 2 nd Batch 3 rd Batch
Sample Acceptance Number Number Number
Stage Tests
ID Criteria
Description
Not less than
filtered Flush C1 Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
Not less than
Initial filtered Assay
C2 95.0% and not
solution - 2
more than 105.0%
A. R. Number
Done By ( Sign & Date )
After Primary Bio burden 1 CFU / 100 mL
filtration C3
(END) A. R. Number
Done By ( Sign & Date )
D1 Sterility No Growth
Description
After Secondary
filtration
(END pH
of the Filling) D2 Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 12 of 10
Effective date Vial Fill Volume
Observed bubble point values
Name of the filter
Stage Pre-integrity Post-integrity
and filtration
Primary filtration
0.2 μm
Filter Integrity
Online filtration
0.2 μm
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 13 of 10
Effective date Vial Fill Volume
8.0. Hold Time Studies
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D3 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D4
(8 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D5 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(12 Hours) D6
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D7 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D8
(18 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D9 Sterility No Growth
Description
pH
After Secondary
filtration D10 Not less than
(24 Hours) 95.0% and not
Assay
more than
105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 14 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D3 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D4
(32 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D5 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(40 Hours) D6
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D7 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D8
(48 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D9 Sterility No Growth
Description
pH
After Secondary
filtration D10 Not less than
(56 Hours) 95.0% and not
Assay
more than
105.0%
A. R. Number
Done By ( Sign & Date )
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 15 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D3 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D4
(64 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D5 Sterility No Growth
Description
After Secondary pH
filtration Not less than
(72 Hours) D6
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
D3 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D4
( Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D5 Sterility No Growth
After Secondary Description
filtration
D6 pH
(12 Hours)
Assay Not less than
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 16 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D7 Sterility No Growth
Description
After Secondary pH
filtration Not less than
D8
(18 Hours) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
D9 Sterility No Growth
Description
pH
After Secondary
filtration D10 Not less than
(24 Hours) 95.0% and not
Assay
more than
105.0%
A. R. Number
Done By ( Sign & Date )
9.0. Filling & Sealing
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
During Description
Filling E1
( for 1flush) Assay Not less than
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 17 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
During
Filling E2 Not less than
( for 2 flush) Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
Filling and
F1 Description
Stoppering
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 18 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
Not less than
90.0% and not
Content
more than 110.0%
uniformity
of the labeled
Initial amount
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
Not less than
90.0% and not
Content
more than 110.0%
Filling and uniformity
of the labeled
Stoppering F2
amount
Middle
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
Description
Not less than
90.0% and not
Content
Filling and more than 110.0%
uniformity
Stoppering F3 of the labeled
(End) amount
Not less than
Assay 95.0% and not
more than 105.0%
A. R. Number
Done By ( Sign & Date )
10.0. Seal integrity / Leak test
ANNEXURE-6
PROCESS VALIDATION PROTOCOL
Product Name AMIKACIN SULPHATE INJECTION , 250 mg / mL
Protocol No. DL-PV001 Page No. 19 of 10
Effective date Vial Fill Volume
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
Seal integrity / Should pass seal
Sealing Leak test integrity test
G1
(Initial)
A. R. Number
Done By ( Sign & Date )
Seal integrity / Should pass seal
Sealing Leak test integrity test
G2
(Middle)
A. R. Number
Done By ( Sign & Date )
Seal integrity / Should pass seal
Sealing Leak test integrity test
G3
(End)
A. R. Number
Done By ( Sign & Date )
11.0. Finished Samples
1 st Batch 2 nd Batch 3 rd Batch
Acceptance Number Number Number
Stage Sample ID Tests
Criteria
As per FP As per FP
Optical Specification Specification
H
inspection
A. R. Number
Done By ( Sign & Date )
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