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Filtration yield

100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AG
45
40
35
30
25
20
15
10
5
0
A5046 A5131 A5437
Batch No.
lumn AG
Filling Yield
95
90
85
80
75
70
65
60
55
% Yield

50
Column AO
45
40
35
30
25
20
15
10
5
0
A5046 A5131 A5437
Batch No.
lumn AO
Sealing Yield
90
85
80
75
70
65
60
55
50
% Yield

45 Column AU
40
35
30
25
20
15
10
5
0
A5046 A5131 A5437
Batch No,
lumn AU
Visual inspection yield
90
85
80
75
70
65
60
55
50
% Yield

45 Column BM
40
35
30
25
20
15
10
5
0
A5046 A5131 A5437
Batch No.
lumn BM
Packing Yield
1200
1150
1100
1050
1000
950
900
850
800
750
700
650
% Yield

600 Column CR
550
500
450
400
350
300
250
200
150
100
50
0
A5046 A5131 A5437
Batch No.
lumn CR
Inprocess pH
3.75

3.5

3.25

2.75

2.5

2.25

2
pH

Column CZ
1.75

1.5

1.25

0.75

0.5

0.25

0
A5046 A5131 A5437
Batch No.
lumn CZ
Specific gravity
1.05
1
0.95
0.9
0.85
0.8
0.75
0.7
0.65
Specific gravity

0.6
0.55
Column DA
0.5
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
Row 5 Row 12 Row 18
Batch No.
lumn DA
Assay
21
20
19
18
17
16
15
14
13
12
Assay

11
Column DB
10
9
8
7
6
5
4
3
2
1
0
A5046 A5131 A5437
Batch No.
lumn DB
Finished pH
4.25
4
3.75
3.5
3.25
3
2.75
2.5
2.25
pH

Column DD
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
Row 5 Row 12 Row 17
Batch No.
lumn DD
Absorbance
0.38

0.35

0.33

0.3

0.28

0.25

0.23
Absorbance

0.2
Column DF
0.18

0.15

0.13

0.1

0.08

0.05

0.03

0
A5046 A5131 A5437
Batch No.
lumn DF
Particulate matter >10u
1500

1400

1300

1200

1100

1000

900
Particles

800
Column DG
700

600

500

400

300

200

100

0
A5046 A5131 A5437
Batch No.
lumn DG
Particulate matter >25u
120
115
110
105
100
95
90
85
80
75
70
Particles

65
60 Column DH
55
50
45
40
35
30
25
20
15
10
5
0
A5046 A5131 A5437
Batch No.
lumn DH
Assay
21
20
19
18
17
16
15
14
13
12
Assay

11
Column DI
10
9
8
7
6
5
4
3
2
1
0
A5046 A5131 A5437
Batch No.
olumn DI
Total Impurities
0.16

0.15

0.14

0.13

0.12

0.11

0.1

0.09
Impurities

0.08 Column DL
0.07

0.06

0.05

0.04

0.03

0.02

0.01

0
A5046 A5131 A5437
Batch No.
olumn DL
Bubble point test
3500

3250

3000

2750

2500

2250

2000
Column AA
BPT

1750
Column AB
1500

1250

1000

750

500

250

0
A5046 A5131 A5437
Batch No.
lumn AA
lumn AB
Filled Volume
2.4
2.3
2.2
2.1
2
1.9
1.8
1.7
1.6
1.5
1.4
1.3
Volume

1.2 Column BH
1.1 Column BI
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
A5046 A5131 A5437
Batch No.
lumn BH
lumn BI
Filled weight
2.6

2.4

2.2

1.8

1.6

1.4
Weight

Column BJ
1.2 Column BK

0.8

0.6

0.4

0.2

0
Row 5 Row 12 Row 18
Batch No.
lumn BJ
lumn BK
Product Code Work Order Number Batch Size

Sl.No. Batch No MFD EXP Bulk Finished Bulk Finished Liters Nos

1 A5046 Feb-05 Jan-08 200904 200934 400025322 400025323 3 1500

2 A5131 Apr-05 Mar-08 200904 200934 400026356 400026420 3 1333

3 A5437 Dec-05 Nov-07 200904 200934 400031031 400031032 3 1333


Batch Size

Temp. Temp. at
Temp. of Qty. of after the end of Temp.
Theoretica Expected Qty. Of the Irinotecan addition of complete after pH of the
Weight l Yield Yield Lacticacid Solutions HCL drug Dissolving cooling Sol.

3.48 3.37 90 3.05 80 0.14 75 70 25 2.82

3.11 3 90 3 80 60 80 78 25 2.7

3.16 3 90 2.94 78 60.15 76 75 25 2.99


Qty. taken for
Qty.of Bulk Sol. Bubble Point Test Filtration

BPT at
NaOH pH after Unit
Consume adjustmen NaOH Preparatio Filtration
d t destroyed Weight Liters n Pre Post ime Weight

10 3.46 240 3.06 3 3337 3232 3227 30 3.05

10 3.49 240 3.06 3 3297 3296 3290 10 3.03

2 3.29 248 3.06 3.01 3294 3247 15 3.05


Qty. taken for Qty. of Filtrate Qty. of Bulk Sol. Calibration Loss
Filtration Obtained Filtration Loss Filled during Filling Total Filled Qty.

% Weight % Wt. % Wt. % Wt. % Wt.

98.83 2.95 95.46 0.1 3.4 2.88 93.26 0.01 0.32 2.89

98.8 2.94 96.07 0.09 2.77 2.76 90.19 0.02 0.65 2.78

99.7 2.96 96.7 0.1 3.1 2.77 90.5 0.09 2.9 2.86
Total Filled Qty. Loss during Filling Filled Qty. Obtained Sealed Qty. Obtained Loss at Sealing Qty. taken for VI

% Wt. % Nos % Nos % Nos % Nos

93.59 0.06 1.88 1244 82.93 1244 82.93 0 0 1244

90.85 0.16 5.22 1185 88.89 1185 88.89 0 0 1185

93.5 0.1 3.3 1174 88.1 1174 88.1 0 0 1174


Qty. taken for VI Rejections Obtained in Visual Inspection Sampled Qty. Fill Volume

% Fibers Particles Vol.Def. Seal Def. Total Nos % Min.

82.93 2 0 7 0 9 82.62 35 2.62 2.27

88.89 2 3 2 0 10 88.14 35 2.62 2.28

88.1 0 5 5 0 10 87.3 20 1.5 2.24


Fill Volume Fill Weight Qty. Sent for Packing

Pack Work Order


Max Min. Max Nos % Code Market Number

2.37 2.3 2.35 1200 80 300801 Domestic 400029240

300801 Domestic 400025937

301024 NCIS 400026586

3002582 Ukraine 400028904

301024 NCIS 400027672

301024 NCIS 400025787

301024 NCIS 400025787

2.38 2.3 2.35 1140 85.52 300801 Domestic 400029687

301024 NCIS 400031164

3003153 Vietnam 400030406

301024 NCIS 400030482

3003169 Venezuela 400030781

3003169 Venezuela 400031585

2.24 2.32 2.42 1144 85.8 3003169 Venezuela 400031586


Inner Cartons Outer Cartons
Labels Consumed Consumed Consumed Leaf lets Consumed

Theoretica Expected
B.Size l Yield Yield Nos % Nos % Nos % Nos

0 468 98 464 94.69 464 96.67 156 91.76 464

0 461 98 461 96.04 461 96.04 155 96.87 461

0 90 98 91 91 91 91 32 80 91

0 11 98 12 60 12 60 6 60 12

0 47 98 48 96 17 85 17 85 48

0 101 98 48 96 48 96 17 85 48

0 101 98 102 92.72 102 92.72 36 90 102

0 402 98 404 96 404 96 137 140 403

0 12 98 14 70 14 70 7 70 13

0 91 98 93 93 93 93 33 82.5 93

0 22 98 24 80 24 80 10 100 23

0 301 98 303 94.7 303 97.7 0 0 302

0 309 98 311 94.21 311 97.18 0 0 10

0 197 98 199 94.76 199 94.76 0 0 199


Inner Cartons
Leaf lets Consumed Labels Destroyed Destroyed Outer Cartons Leaflets Destroyed

% Nos % Nos % Nos % Nos % To BSR

96.67 26 5.31 16 3.33 14 8.24 14 3.33 462

98.08 19 3.96 19 3.96 5 1.92 9 1.92 366

91 9 9 9 9 8 9 9 9 80

60 8 40 8 40 4 40 8 40 10

96 2 4 2 4 3 15 2 4 46

96 2 4 2 4 3 15 2 4 46

92.72 8 7.28 8 7.28 4 10 8 7.28 100

98 16 4 16 4 3 2 7 2 11

65 6 30 6 30 3 30 7 35 11

93 7 7 7 7 7 7.5 7 7 90

76.7 6 20 6 20 0 0 7 23.3 21

97.4 17 5.3 7 2.3 0 0 8 2.6 300

97.18 19 5.79 9 2.82 0 0 10 2.82 304

94.76 11 5.24 11 5.24 0 0 11 5.24 196


Total Packed Qty. of
Total Packing Loss the Batch Total Yield

Control
Sample Others Nos % Nos % Nos % Nos %

1 0 463 30.87 6 1177 78.47 299 79.93

10 84 460 30.67 1 0.06 460 30.67

10 0 90 6

1 0 11 0.73

1 0 47 3.13

1 0 47 3.13

1 0 10 6.73

1 0 12 0.9 1137 85.29 1137 85.29

1 0 12 0.9 0

1 0 91 6.83 0

1 0 22 17 0

1 0 301 22.6 0

5 0 309 23.18 3 0.22

1 0 197 14.7 0
Total Loss

Specific Extractabl
Nos % AR NO. pH Gravity Assay AR NO pH e Vol

300 200 10968 3.36 1.03 20.4 3.4 2

196 14.7 13475 3.58 1.04 20.3 4.15 2


Impurities
77,11-
Diethyl-
10(4-
pipiridinopi
eridine)car
bonyl
camptothe
Color >= 10u >=25u Assay cin HCL Any Other Total

0.31 1488 118 20.15 0 0.07 0.16

0.37 1267 37 20.34 0 0.09 0.11


Filtration Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AG
45
40
35
30
25
20
15
10
5
0
Row 4 Row 5 Row 6 Row 8 Row 10 Row 11 Row 13 Row 17 Row 19 Row 21 Row 24 Row 26 Row 28
Batch No.
lumn AG
Filling Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AO
45
40
35
30
25
20
15
10
5
0
Row 4 Row 5 Row 6 Row 8 Row 10 Row 11 Row 13 Row 17 Row 19 Row 21 Row 24 Row 26 Row 28
Batch No.
lumn AO
Sealing Yield
95
90
85
80
75
70
65
60
55
% Yield

50
Column AU
45
40
35
30
25
20
15
10
5
0
Row 4 Row 5 Row 6 Row 8 Row 10 Row 11 Row 13 Row 17 Row 19 Row 21 Row 24 Row 26 Row 28
Batch No.
lumn AU
Filled Vilume
5.5
5.25
5
4.75
4.5
4.25
4
3.75
3.5
3.25
3
Volume

2.75 Column BH
Column BI
2.5
2.25
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn BH
lumn BI
Filled Weight
5.75
5.5
5.25
5
4.75
4.5
4.25
4
3.75
3.5
3.25
Weight

3 Column BL
2.75 Column BM
2.5
2.25
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn BL
lumn BM
Packing Yield
95
90
85
80
75
70
65
60
55
% Yield

50
45 Column CW
40
35
30
25
20
15
10
5
0
Row 4 Row 5 Row 6 Row 8 Row Row Row Row Row Row Row Row Row Row
10 11 13 17 19 20 23 24 26 28
Batch No.
umn CW
Inprocess pH
3.75

3.5

3.25

2.75

2.5

2.25

2
pH

1.75 Column DB

1.5

1.25

0.75

0.5

0.25

0
Row 4 Row 5 Row 6 Row 8 Row Row Row Row Row Row Row Row Row Row
10 11 13 17 19 20 21 24 26 28
Batch No.
lumn DB
Specific gravity
1.1
1.05
1
0.95
0.9
0.85
0.8
0.75
0.7
Specific gravity

0.65
0.6
0.55 Column DC
0.5
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DC
Inprocess Assay
21
20
19
18
17
16
15
14
13
12
Assay

11
Column DD
10
9
8
7
6
5
4
3
2
1
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DD
Finished pH
4.25
4
3.75
3.5
3.25
3
2.75
2.5
2.25
pH

Column DF
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DF
Extractable Volume
5
4.75
4.5
4.25
4
3.75
3.5
3.25
3
2.75
Volume

2.5 Column DG
2.25
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
Column DG
Absorbance
0.58
0.55
0.53
0.5
0.48
0.45
0.43
0.4
0.38
0.35
0.33
ABS>

0.3
0.28 Column DH
0.25
0.23
0.2
0.18
0.15
0.13
0.1
0.08
0.05
0.03
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DH
Particulate matter >=10u
2000
1900
1800
1700
1600
1500
1400
1300
1200
1100
Particles

1000 Column DI
900
800
700
600
500
400
300
200
100
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
batch No.
olumn DI
Particulate Matter >= 25u
525
500
475
450
425
400
375
350
325
300
Particles

275
Column DJ
250
225
200
175
150
125
100
75
50
25
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
olumn DJ
Finished Assay
22
21
20
19
18
17
16
15
14
13
12
Assay

11 Column DK
10
9
8
7
6
5
4
3
2
1
0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DK
Total Impurities
0.38

0.35

0.33

0.3

0.28

0.25

0.23
Impurities

0.2
Column DN
0.18

0.15

0.13

0.1

0.08

0.05

0.03

0
A5021 A5022 A5079 A5098 A5130 A5161 A5194 A5342 A5351 A5352 A5370 A5427 A5430 A5438
Batch No.
lumn DN
Product Code Work Order Number Batch Size

Sl.No
. Batch No MFD EXP Bulk Finished Bulk Finished Liters Nos Weight

1 A5021 Jan-05 Dec-06 200904 200905 400024966 400024967 3 566 3.06

2 A5022 Jan-05 Dec-06 200904 200905 400024968 400024969 3 566 3.06

3 A5079 Mar-05 Feb-07 200904 200905 400025767 400025768 3 566 3.16

4 A5098 Mar-05 Feb-07 200904 200905 400026098 400026908 3 566 3.03

5 A5130 Apr-05 Mar-07 200904 200905 400026355 400026419 3 566 3.1

6 A5161 May-05 Apr-07 200904 200905 400026881 400026882 3 566 3.11

7 A5194 May-05 Apr-07 200904 200905 400027350 400027351 3 566 3.15

8 A5342 Sep-05 Aug-07 200904 200905 400029536 400029537 3 566 3

9 A5351 Sep-05 Aug-07 200904 200905 400029575 400029576 3 566 3


10 A5352

11 A5370 Oct-05 Sep-07 200904 200905 400029884 400029885 3 566 3

12 A5427 Dec-05 Nov-07 200904 200905 400030825 400030826 3 566 3.08

13 A5430 Dec-05 Nov-07 200904 200905 400030869 400030870 3 566 3.18


A5438 Dec-05 Nov-07 200904 200905 400031050 400031051 3 566 3.18
Temp. Temp. at
Temp. of Qty. of after the end of Temp. NaOH
Theoretica Expected Qty. Of the Irinotecan addition of complete after pH of the Consume
l Yield Yield Lacticacid Solutions HCL drug Dissolving cooling Sol. d

3 90 3.05 85 60.07 74 70 24 2.78 15

3 90 3.05 70 60.19 75 75 25 2.76 12

3 90 3.05 80 60.03 75 72 25 2.87 10

3 90 3.05 80 60 75 73 25 2.9 10

3 90 3 80 60 80 78 25 2.78 10

3 90 3 80 60 80 80 25 2.88 10

3 90 3 80 60.13 78 77 25 3.1 7

3 90 3 80 60.13 78 77 25 3.28 5

3 90 3 78 60.14 76 74 25 3.16 3

3 90 3 78 60.43 76 76 23 3.18 5

3 90 2.9 75 60.43 74 73 25 3.15 2

3 90 2.94 78 60.21 77 75 25 3.12 2


3 90 2.94 79 60.15 76 74 25 2.98 2
Qty. taken for
Qty.of Bulk Sol. BPT at Bubble Point Test Filtration
pH after Unit
adjustmen NaOH Preparatio Filtration
t destroyed Weight Liters n Pre Post time Weight %

3.35 235 3.06 3 3325 3233 3220 20 3.02 98.83

3.35 238 3.06 3 3470 3327 3423 15 3.03 98.82

3.4 240 3.06 3 3232 3243 3245 20 3.13 98.83

3.5 240 3.06 3 3339 3297 3244 13 3 98.85

3.45 240 3.06 3 3388 3291 3342 10 3.03 98.85

3.5 240 3.06 3 3287 3336 3238 13 3.02 98.8

3.45 243 3.06 3 3270 3275 3329 10 3.02 98.79

3.41 245 3.06 3 3200 3900 35 3.05 99.69

3.31 247 3.06 3 3295 3248 20 3.05 99.67

3.32 245 3.06 3 3247 3295 3246 20 3.05 99.7

3.31 248 3.06 3 3347 3296 3397 13 3.05 98.9

3.3 248 3.06 3 3347 3194 3297 15 3.05 99.7


3.3 248 3.06 3.01 3498 3247 3344 15 3.05 99.8
Qty. of Filtrate Qty. of Bulk Sol. Calibration Loss
Obtained Filtration Loss Filled during Filling Total Filled Qty.

Weight % Wt. % Wt. % Wt. % Wt. %

2.94 96.07 0.08 2.74 2.87 93.69 0.02 0.67 2.89 94.34

2.95 96.31 0.01 2.51 2.74 89.45 0.02 0.65 2.76 90.1

2.94 92.89 0.19 5.93 2.72 89.54 0.04 2.8 91.6

2.81 92.64 0.19 6.19 2.72 89.54 0.04 1.15 2.75 90.7

2.98 97.38 0.05 1.47 2.85 93.13 0.04 1.34 2.89 94.48

2.93 95.75 0.09 3.07 2.83 92.32 0.03 1.07 2.86 93.39

2.98 97.38 0.04 1.4 2.8 91.5 0.03 1.11 2.83 92.61

3 98.03 0.05 1.63 2.88 94.11 0.02 0.65 2.9 94.64

2.9 94.7 0.15 1.63 2.85 93.13 0.05 1.63 2.9 94.7

2.95 96.4 0.1 3.3 2.86 93.4 0.04 1.3 2.9 94.8

2.91 94.36 0.15 4.7 2.79 90.53 0.07 2.33 2.86 92.87

2.96 96.7 0.09 2.84 2.9 0.07 2.3 2.91 95.1


3.01 98.4 0.04 1.31 2.91 95.12 0.05 1.6 2.96 98.3
Loss during Filling Filled Qty. Obtained Sealed Qty. Obtained Loss at Sealing Qty. taken for VI

Wt. % Nos % Nos % Nos % Nos %

0.05 1.73 531 93.81 531 93.81 0 0 531 93.81

0.19 6.2 521 92.04 521 92.04 0 0 521 92.04

0.14 494 87.27 494 87.27 0 0 494 87.27

0.06 1.94 507 89.37 507 89.37 0 0 507 89.37

0.09 2.91 520 91.87 520 91.87 0 0 520 91.87

0.07 2.35 513 90.64 513 90.64 0 0 513 90.64

0.15 4.77 512 90.46 512 90.46 0 0 512 90.46

0.12 3.98 518 91.52 518 91.52 0 0 518 91.52

0 0 517 91.34 517 91.34 0 0 517 91.34

0.05 1.6 521 92.04 521 92.04 0 0 521 92.04

0.05 1.49 509 89.93 5.09 89.93 0 0 509 89.93

0.05 1.6 506 89.4 506 89.4 0 0 506 89.4


0.05 1.6 517 91.3 517 91.3 0 0 517 91.3
Rejections Obtained in Visual Inspection Sampled Qty. Fill Volume

Min. (5.20 Max (5.4


Fibers Particles Vol.Def. Seal Def. Total Nos % ml) ml)

0 0 2 0 2 93.45 35 6.18 5.29 5.3

1 1 2 0 4 91.33 35 6.18 5.29 5.37

2 0 2 0 4 86.56 35 6.18 5.31 5.31

0 0 1 0 1 89.39 35 6.18 5.31 5.32

4 3 0 0 7 90.63 35 6.18 5.27 5.36

3 1 1 0 5 89.75 35 6.18 5.29 5.37

3 2 1 0 6 89.39 35 6.18 5.23 5.37

5 5 13 0 23 91.45 20 3.53 5.25 5.34

3 5 7 0 10 89.57 20 3.53 5.24 5.24


0

3 3 5 0 11 90.13 20 3.53 5.25 5.35

1 0 0 0 1 89.75 20 3.53 5.33 5.34

3 3 0 0 6 88.3 20 3.5 5.28 5.33


0
0 1 1 0 2 91 20 3.5 5.29 5.38

0
Fill Weight Range Filled Weight Qty. Sent for Packing

Pack
Min. Max Min. Max Nos % Code Market

5.3 5.51 5.4 5.4 494 87.27 300713 Domestic

5.31 5.51 5.43 5.48 482 85.15 300173 Domestic

5.49 5.7 5.6 5.6 455 80.38 300713 Domestic

3002210 Belarus

5.26 5.46 5.37 5.38 471 83.21 300713 Domestic

300713 Domestic

5.38 5.59 5.45 5.55 478 84.45 300713 Domestic

5.4 5.62 5.5 5.58 473 83.57 300173 Domestic

300173 Domestic

5.47 5.68 5.5 5.65 471 83.21 301023 NCIS

300713 Domestic

301023 NCIS

300713 Domestic

5.45 5.66 5.49 5.6 475 87.92 300713 Domestic

300713 Domestic

5.47 5.62 5.51 5.51 487 86.04 300713 Domestic

5.4 5.61 5.45 5.55 490 86.6 301023 NCIS

301023 NCIS

3003168 Venezuela

5.35 5.55 5.48 5.49 488 86.22 300713 Domestic

3000968 Brazil

5.51 5.72 5.6 5.65 480 84.8 300713 Domestic


5.51 5.72 5.6 5.7 495 87.5 300713 Domestic

3003168 Venezuela
Inner Cartons Outer Cartons
Labels Consumed Consumed Consumed

Work Order Theoretica Expected


Number B.Size l Yield Yield Nos % Nos % Nos %

400025228 0 494 98 493 94.8 493 96.6 166 97.6

400025231 0 482 98 477 93.52 477 95.4 159 93.52

400027668 0 185 98 186 93 186 97.89 63 90

400027046 0 270 98 271 93.44 271 96.78 91 91

400028243 0 225 98 226 94.16 226 98.2 76 95

400027669 0 246 98 247 95 247 95 83 92.22

400027670 0 470 98 479 95.8 479 97.75 161 94.7

400028779 0 342 98 343 95.28 343 96 115 95.83

400028244 0 130 98 131 93.57 131 93.57 45 90

400027673 0 225 98 226 94.16 226 98.26 76 95

400029261 0 101 98 102 92.7 102 92.7 35 87.5

400029526 0 5 98 7 70 7 70 5 50

400029491 0 139 98 140 93.33 140 93.33 49 98

400029791 0 452 98 454 94.58 454 96.59 152 95

400030294 0 23 98 25 83.3 25 83.3 9 90

400030295 0 487 98 489 95.9 489 97.8 165 97.1

400030483 0 12 98 14 70 14 70 7 70

400031165 0 12 98 14 70 14 70 7 70

400031632 0 466 99 466 95.1 466 97.08 0 0

400031313 0 20 98 22 73.33 22 73.33 9 90

400031161 0 468 99

400031617 0 12 98
400031614 0 253 98 255 94.4 255 98.1 86 95.5

400031637 0 242 99 244 93.8 244 92.1 0 0


Inner Cartons
Leaf lets Consumed Labels Destroyed Destroyed Outer Cartons Leaflets Destroyed

Nos % Nos % Nos % Nos % Nos %

493 98.6 27 5.2 17 3.4 4 2.4 7 1.4

490 97.34 33 6.48 23 4.6 11 6.48 13 2.66

186 97.89 14 7 4 2 7 10 4 2.11

271 96.78 19 6.56 19 3.22 9 9 19 3.22

226 98.26 14 5.84 4 1.74 4 5 4 0.74

247 98.8 13 5 13 5 7 7.78 3 1.2

479 94.75 21 4.2 11 2.25 9 5.3 1 2.25

343 98 17 4.72 7 2 5 4.17 7 2

131 93.57 9 6.43 9 6.43 5 10 9 6.43

226 98.26 14 5.84 4 1.74 4 5 4 1.74

102 92.7 8 7.3 8 7.3 5 12.5 8 7.3

7 70 3 30 3 30 5 50 3 30

140 100 10 6.67 10 6.67 1 2 0 0

454 98.69 26 5.42 16 3.41 8 5 6 1.31

24 80 5 6.7 5 6.7 1 10 6 20

488 99.6 21 4.1 11 2.2 5 2.9 2 0.4

13 65 6 30 6 30 3 30 7 35

13 65 6 30 6 30 3 30 7 35

465 96.87 24 4.9 14 0 0 2.92 15 3.13

21 70 8 16.64 8 16.64 1 10 9 30
254 97.7 15 5.6 5 1.9 4 4.5 6 2.3

243 97.2 16 6.2 21 7.9 0 0 7 2.8


Total Packed Qty. of
Total Packing Loss the Batch Total Yield

Control
To BSR Sample Others Nos % Nos % Nos % Nos

462 30 0 492 86.92 2 0.35 492 86.92 492

446 30 0 476 84.09 6 1.06 476 84.09 476

161 24 0 185 32.68 0 0 455 80.38 455

264 6 0 270 47.7

204 21 0 225 39.75 0 0 471 83.21 471

231 15 0 246 43.46

448 30 0 478 84.45 0 0 478 84.45 478

319 23 0 342 60.42 1 0.17 473 83.57 473

123 7 0 130 22.96

210 15 0 225 39.75 1 0.18 470 83.05 470

100 1 0 101 17.84

4 1 0 5 0.88

137 1 0 138 24.38

450 2 0 452 79.85 0 0 475 83.9 475

21 2 0 23 4.1

483 4 0 487 86.04 0 0 487 86.04 487

11 1 0 12 2.1

11 1 0 12 2.1

460 2 0 462 81.62 4 0.7 490 86.6 486

19 1 0 20 3.5 0 0 488 86.2 508

465 3 0 468 82.7 0 0

9 1 0 10 1.8 500
465 3 0 468 82.7 0 0 480 84.8
251 2 0 253 44.7 0 0 495 87.5 515

240 2 0 242 42.8 0 0


Total Yield Total Loss

Specific
% Nos % AR NO. pH Gravity Assay AR NO pH

86.92 2 0.35 10125 3.1 1.02 19.9 10325 3.3

84.09 90 15.9 10326 3.34 1.02 20.3 10163 3.34

80.38 111 19.61 11994 3.14 1.06 20.3 12738 3.02

83.21 95 16.76 12691 3 1.01 20.7 13345 3.6

84.45 88 15.54 13413 3.65 1.04 20.3 13595 4.1

83.57 93 16.43 14466 3.48 1.04 20.3 14821 3.45

83.05 101 17.85 15526 3.3 1.05 20.3 16072 3.41

83.9 91 16.1 20343 2.91 1.05 20.9 20611 3.14

86.04 79 13.96 20613 3.14 1.05 20.5 20974 3.15

21127 3.11 1.04 20.8 21617 3.18

85.9 80 14.1

89.7 58 10.3 23152 3.15 1.03 20.8 23280 2.98

88.3 66 11.66 23475 3.05 1.06 20.5 23643 3.06


90.98 51 9.01 23650 3.05 1.06 20.2 23847 3.08
Impurities
77,11-Diethyl-10(4-
Extractabl pipiridinopieridine)carbonyl
e Vol Color >= 10u >=25u Assay camptothecin HCL Any Other Total

5 0.28 1914 505 20.1 20.1 0.08 0.23

5 0.29 1516 403 20.9 0 0.16 0.35

5 0.54 190 5 20.1 0 0.06 0.21

5 0.45 256 8 21.3 0.18 0.09 0.17

5 0.33 308 8 20.2 0 0.05 0.08

5 0.34 820 5 20.7 0.32 0.16 0.3

5 0.37 28 1 19.8 0 0.08 0.08

5 0.56 15 2 20.4 0.19 0.03 0.22

5 0.57 7 1 20 19 0.04 0.11

5 0.57 6 1 20.9 0 0.05 0.12

5 0.42 20 3 20.5 0 0.04 0.09

5 0.43 164 2 19.9 0 0.2 0.02


5 0.42 94 5 20.1 0 0.03 0.04
Filtration Yield
95
90
85
80
75
70
65
60
55
% Yield

50
Column AE
45
40
35
30
25
20
15
10
5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn AE
Filling Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AM
45
40
35
30
25
20
15
10
5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn AM
Sealing Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AS
45
40
35
30
25
20
15
10
5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn AS
Filled Volume
0.6
0.58
0.55
0.53
0.5
0.48
0.45
0.43
0.4
0.38
0.35
0.33
Volume

0.3 Column BJ
0.28 Column BK
0.25
0.23
0.2
0.18
0.15
0.13
0.1
0.08
0.05
0.03
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn BJ
lumn BK
Filled Weight
0.65

0.6

0.55

0.5

0.45

0.4

0.35
Weight

Column BL
0.3 Column BM

0.25

0.2

0.15

0.1

0.05

0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn BL
lumn BM
Visual Inspection Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column BO
45
40
35
30
25
20
15
10
5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn BO
Packing Yield
100
95
90
85
80
75
70
65
60
55
%Yield

50 Column CW
45
40
35
30
25
20
15
10
5
0
Row 6 Row 12 Row 17 Row 18 Row 20 Row 23
Batch No.
umn CW
Inprocess pH
4.5
4.25
4
3.75
3.5
3.25
3
2.75
2.5
pH

2.25 Column DB
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn DB
Specific gravity
1.1
1.05
1
0.95
0.9
0.85
0.8
0.75
0.7
Specific Gravity

0.65
0.6
0.55 Column DC
0.5
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1
0.05
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn DC
Total Impurities
0.43
0.4
0.38
0.35
0.33
0.3
0.28
0.25
Impurities

0.23
Column DF
0.2
0.18
0.15
0.13
0.1
0.08
0.05
0.03
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
batch No.
lumn DF
Inprocess assay
42.5
40
37.5
35
32.5
30
27.5
25
22.5
assay

Column DG
20
17.5
15
12.5
10
7.5
5
2.5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn DG
Finished pH
4.5
4.25
4
3.75
3.5
3.25
3
2.75
2.5
pH

2.25 Column DI
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
olumn DI
Extractable Volume
0.75

0.7

0.65

0.6

0.55

0.5

0.45
Volume

0.4
Column DJ
0.35

0.3

0.25

0.2

0.15

0.1

0.05

0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
olumn DJ
Absorbance
0.38

0.35

0.33

0.3

0.28

0.25

0.23

0.2
ABS.

Column DK
0.18

0.15

0.13

0.1

0.08

0.05

0.03

0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn DK
Particulate Matter >=10u
1000
950
900
850
800
750
700
650
600
550
Particles

500 Column DL
450
400
350
300
250
200
150
100
50
0
Row 4 Row 8 Row 13 Row 18 Row 19 Row 21
Batch No.
olumn DL
Particulate Matter >=25u
325

300

275

250

225

200
Particles

175
Column DM
150

125

100

75

50

25

0
Row 4 Row 8 Row 13 Row 18 Row 19 Row 21
Batch No.
lumn DM
Water Content
2.3
2.2
2.1
2
1.9
1.8
1.7
1.6
1.5
1.4
Water content

1.3
1.2
1.1 Column DN
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
Batch No.
lumn DN
Total Impurities
0.75

0.7

0.65

0.6

0.55

0.5

0.45
Impurities

0.4
Column DQ
0.35

0.3

0.25

0.2

0.15

0.1

0.05

0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
batch No.
lumn DQ
Finished assay
42.5
40
37.5
35
32.5
30
27.5
25
22.5
Assay

Column DR
20
17.5
15
12.5
10
7.5
5
2.5
0
A5188,89 A5072,73 A5335,36 A5257,58 A5372 A5402,03
batch No.
lumn DR
Product Code Work Order Number Batch Size
Sl.N
Batch No MFD EXP
o.
Bulk Finished Bulk Finished Liters Nos

1 A5188,89 May.2005 apr.2007 200690 200802 400027306 400027307 3.1 1750

2 A5072,73 Mar.2005 Feb.2007 200690 200802 400025675 400025676 3.1 750

3 A5335,36 Sep.2005 aug.2007 200690 200802 400029500 400029501 3.1 777

4 A5257,58 Jul.2005 Jun.2007 200690 200802 400028151 400028152 3.1 536

5 A5372 Oct.2005 Sep.2007 200690 200802 400029938 400029939 3.1 783

6 A5402,03 Nov.2005 Oct.2007 200690 200802 400030440 400030441 3.1 1050


Batch Size Final pH
pH of pH after Total Qty. of after qty. of
Theoretica Expected Mixing
Polysorbat addition of quantity of Citric acid addition of Docetaxel
l Yield Yield time
Weight e Citric acid Citric acid destroyed anhydrous (gms)
citric acid

3.19 3.1 4.85 4.85 5.25 0.75 4.5 132.89 1:40

3.19 3.1 95 5 5 1 4.5 132.34 1:35

0 3.1 95 4.7 5 1 4.4 133 1:45

0 3.1 95 4.5 4.7 5 1 4.4 132.68 1:40

0 3.1 95 4.5 4.71 5.5 0.5 4.48 133.15 1:20

0 3.1 95 4.72 5 1 4.38 132.84 1:15


Qty. taken for Qty. of Filtrate
Qty.of Bulk Sol. Bubble Point Test
Filtration Filtration Obtained
Temp. during MFG.
time
Weight Liters Pre Post Weight % Weight
min. Max.
21 22 3.33 3.1 1.3 3297 2.95 88.64 2.75

21 22 3.3 3.1 2.25 3278 3.3 98.3 3.06

23 23 3.33 3.1 2.25 4 3.27 2.83

23 24 3.33 3.14 2.2 3285 3.29 98.79 3.11

23 23 3.11 3 3244 3.32 100 3.05

23 23 3.33 3.1 3.05 3348 3.32 99.8 2.97


Qty. of Filtrate Qty. of Bulk Sol. Calibration Loss
Filtration Loss Total Filled Qty. Loss during Filling
Obtained Filled during Filling
% Wt. % Wt. % Wt. % Wt. % Wt.

83 0.2 6.06 0.92 27.5 0 0.12 2.11 63.48 0.26

91.15 0.24 7.14 0.46 0.01 1.36 0.02 0.21

85.11 0.37 11.21 1.93 58.42 0.02 0.6 2.82 85.46 0.01

93.4 0.18 5.32 0.2 5.98 0.02 0.6 2.91 97 0.2

92.42 0.27 6.3 0.45 13.51 0 0.06 2.9 87.93 0.15

89.3 0.25 7.5 0.37 11 2.97 89.3


Loss during Filling Filled Qty. Obtained Sealed Qty. Obtained Loss at Sealing Qty. taken for VI Rejections Obtai

% Nos % Nos % Nos % Nos % Fibers

7.77 1439 82.22 1439 82.22 0 0 1439 82.22 0

731 97.46 731 97.46 0 0 731 97.46 0

0.42 777 100 777 100 0 0 777 100 0

6.07 313 53.4 313 53.4 0 0 313 53.4 0

4.78 701 89.5 701 89.5 0 0 701 89.5 0

580 55.2 580 55.2 0 0 580 55.2 0


Rejections Obtained in Visual Inspection Sampled Qty. Fill Volume Fill Weight

Particles Vol.Def. Seal Def. Total Nos % Min. Max Min.

0 2 0 2 129.25 50 2.85 0.58 0.6 0.63

0 0 0 0 140.8 50 6.66 0.58 0.6 0.63

0 0 0 0 131.75 33 4.25 0.58 0.6 0.62

0 0 0 0 99.07 50 9.33 0.58 0.6 0.63

0 0 0 0 118.3 33 4.2 0.58 0.6 0.63

0 6 0 6 84.5 33 3.14 0.58 0.6 0.62


Fill Weight Filled Volume Filled Weight Qty. Sent for Packing
Pack
Market
Code
Max Min. Max Min. Max Nos %

0.67 0.59 0.59 0.64 0.64 1387 79.25 300503 Domestic

300503 Domestic

301026 NCIS

300503 Domestic

0.65 0.58 0.6 0.63 0.65 681 90.8 300503 Domestic

301026 NCIS

300503 Domestic

301026 NCIS

301026 NCIS

0.65 0.59 0.59 0.63 0.64 744 98.75 300503 Domestic


NCIs(Peru
3002721
)
300503 Domestic

300503 Domestic

301026 NCIS

0.65 0.59 0.59 0.64 0.64 263 49.07 300503 Domestic

0.65 0.59 0.59 0.64 0.64 668 85.3 300503 Domestic

300503 Domestic

0.61 0.59 0.59 0.63 0.63 541 51.5 301026 NCIS

300503 Domestic

301026 NCIS
Inner Cartons Outer Cartons
Labels Consumed
Work Order Theoretica Expected Consumed Consumed
B.Size
Number l Yield Yield
Nos % Nos % Nos

400027818 0 375 98 159 93.52 159 93.52 21

400028793 0 501 98 28 93.33 28 93.33 0

400028429 0 63 98 447 95.1 447 97.17 58

400029177 0 448 98 26 86.66 26 86.66 0

400026261 0 158 98 26 876.6 26 86.6 0

400026589 0 27 98 376 96.4 376 96.4 48

400027817 0 446 98 502 94.72 502 96.54 64

400026588 0 25 98 64 91.4 64 91.4 0

400026884 0 25 98 449 95.53 449 97.61 57

400030130 0 301 98 303 94.69 303 94.69 40

400029969 0 27 98 29 96.67 28 93.33 0

400030251 0 108 98 110 91.7 110 91.7 16

400029795 0 303 98 305 95.31 305 95.38 40

400029963 0 5 98 7 70 7 70 0

400029489 0 263 98 265 94.6 265 98.1 34

400030361 0 252 98 254 94.1 254 97.7 34

400030806 0 141 98 143 95.33 143 95.33 20

400030864 0 38 98

400030843 0 401 98 403 95.95 403 95.29 52

400030864 0 38 98 40 100 40 100 0


Outer Cartons Inner Cartons
Leaf lets Consumed Labels Destroyed Outer Cartons Leaflets Destroyed
Consumed Destroyed
% Nos % Nos % Nos % Nos % Nos

70 159 99.37 11 6.48 11 6.48 9 30 1

0 28 93.33 2 6.67 2 6.67 0 0 2

96.66 447 99.33 23 4.9 13 2.83 2 3.34 3

0 26 86.66 4 13.34 4 13.34 0 0 4

0 26 86.6 4 13.4 4 13.4 0 0 4

96 376 98.9 14 3.6 14 3.6 2 4 4

91.43 502 98.43 28 5.28 18 3.46 6 8.57 8

0 64 91.4 6 8.6 6 8.6 0 0 6

95 449 99.78 21 4.47 11 2.39 3 5 1

100 303 94.69 17 5.31 17 5.31 0 0 17

0 29 96.67 1 3.33 2 6.67 0 0 1

80 109 90.8 10 8.3 10 8.3 4 20 11

100 305 98.38 15 4.69 5 1.62 0 0 5

0 6 40 3 30 3 30 0 0 4

85 264 97.7 15 5.4 5 1.9 6 15 6

85 253 97.3 16 5.9 6 2.3 6 15 7

100 142 94.66 7 4.67 7 4.67 0 0 8

86.66 402 98.04 17 4.05 7 1.71 8 13.34 8

0 39 97.5 0 0 0 0 0 0 1
Total Packed Qty. of
Leaflets Destroyed Total Packing Loss
Control the Batch
To BSR Others
Sample
% Nos % Nos % Nos %

0.63 158 0 158 21.06 0 0

6.67 26 1 27 3.69 0 0

0.37 429 17 446 59.47 0 0 681 90.8

13.34 24 1 25 3.33 0 0 25 3.33

13.4 24 1 25 3.33 0 0

1.1 371 4 375 21.42 0 0

1.57 500 1 501 28.63 0 0

8.6 62 1 63 3.6 0 0

0.22 445 3 448 25.6 0 0 1387 79.26

5.31 300 1 301 38.73 0 0

3.33 26 1 27 3.5 0 0

9.2 101 7 108 13.89 0 0

1.62 300 3 303 38.99 0 0

40 4 1 5 0.6 0 0 744 95.75

2.3 250 13 263 46.71 0 0 263 46.71

2.7 0 0

5.34 140 1 141 18 0 0 668 85.31

0 0

1.96 400 1 401 38.19 0 0

2.5 37 1 0 38 3.6 0 0
Total Yield Total Loss Related Substances
Specific
AR NO. pH
Gravity 2-epi 7-epi
Nos % Nos %
docetaxel docetaxel

15460 4.48 1.08 0 0

681 90.8 69 9.2

11831 4.22 1.08 0 0.01

1387 79.26 363 20.74

20252 4.29 1.08 0.06 0.15

744 95.75

263 46.71 273 48.47 17250 4.28 1.08 0.05 0

21248 4.33 1.08 0 0

668 85.31 125 14.69

22371 4.33 1.07 0.09 0.12


ated Substances Related Substanc
Extractabl
Assay AR NO pH Color >= 10u >=25u water
Total e Vol 2-epi
impurities docetaxel

0.05 42 15878 4.24 0.7 0.36 974 303 1.3 0.16

0.29 39.9 12260 4.24 0.6 0.3 855 157 0.9 0.05

0.32 41.1 20931 4.28 0.5 0.36 19 2 1.1 0.06

0.11 39.3 17447 4.26 0.6 0.26 43 5 2.2 0

0.21 40.7 21707 4.33 0.5 0.36 84 3 1.8 0.1

0.41 40.4 22741 4.33 0.5 0.36 130 15 1.3 0.1


Related Substances
Assay
7-epi Total
docetaxel impurities

0.08 0.7 40.55

0 0.15 40.84

0.18 0.52 41.6

0 0 39.82

0.09 0.11 40.75

0 0.59 40.41
Filling Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AQ
45
40
35
30
25
20
15
10
5
0
A5179 A5074 A5259 A5337 A5373 A5399,400
Batch No.
lumn AQ
sealing Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column AS
45
40
35
30
25
20
15
10
5
0
A5179 A5074 A5259 A5337 A5373 A5399,400
batch No.
lumn AS
Filled Volume
2.4
2.3
2.2
2.1
2
1.9
1.8
1.7
1.6
1.5
1.4
1.3
Volume

1.2 Column BJ
1.1 Column BK
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
A5179 A5074 A5259 A5337 A5373 A5399,400
batch No.
lumn BJ
lumn BK
Filled Weight
2.6

2.4

2.2

1.8

1.6

1.4
Weight

Column BL
1.2 Column BM

0.8

0.6

0.4

0.2

0
A5179 A5074 A5259 A5337 A5373 A5399,400
Batch No.
lumn BL
lumn BM
Visual Inspection Yield
100
95
90
85
80
75
70
65
60
55
% Yield

50 Column BO
45
40
35
30
25
20
15
10
5
0
A5179 A5074 A5259 A5337 A5373 A5399,400
batch No.
lumn BO
Packing Yield
95
90
85
80
75
70
65
60
55
% Yield

50
Column CU
45
40
35
30
25
20
15
10
5
0
Row 8 Row 12 Row 13 Row 18 Row 21
Batch No.
lumn CU
Finished pH
4.5
4.25
4
3.75
3.5
3.25
3
2.75
2.5
pH

2.25 Column DI
2
1.75
1.5
1.25
1
0.75
0.5
0.25
0
A5179 A5074 A5259 A5337 A5373 A5399,400
Batch No.
olumn DI
Product Code Work Order Number Batch Size

Sl.No. Batch No MFD EXP Bulk Finished Bulk Finished Liters

1 A5179 May.2005 Apr.2007 200690 200803 400027117 400027118 3.1

2 A5074 Mar.2005 feb.2007 200690 200803 400025677

3 A5259 Jul.2005 jun.2007 200690 200803 400028153

4 A5337 Sep.2005 Aug.2007 200690 200803 400029502

5 A5373 Oct.2005 Sep.2007 200690 200803 400029940

A5399,40
60 Nov.2005 Oct.2007 200690 200803 400030402 400030403 3.1
Final pH
Batch Size after
pH of pH after Total Qty. of addition of qty. of
Theoretica Expected Polysorbat addition of quantity of Citric acid anhydrous Docetaxel
Nos Weight l Yield Yield e Citric acid Citric acid destroyed citric acid (gms)

1200 3.19 3.1 95 5 5 1 5 132.44

1000

446

341

571

930 4.68 4.68 5 1 4.22 132.62


Qty. taken for
Qty.of Bulk Sol. Bubble Point Test Filtration
Filtration
Mixing Temp. during MFG. Weight Liters time Pre Post Weight %
time min. Max.

2.36 21 22 3.3 3.1 1.3 3245 2.92 88.52

2.05 23 23 3.33 3.1 2.4 3244 3.32 100


Qty. of Filtrate Qty. of Bulk Sol. Calibration Loss
Obtained Filtration Loss Filled during Filling Total Filled Qty.

Weight % Wt. % Wt. % Wt. % Wt. %

2.72 82.42 0.2 6.09 2.2 66.64 0.03 0.76 2.22 67.39

0.02 0.44

0.02 0.66

0.01

0 0

2.97 89.4 0.35 10.6 2.32 69.9 0.02 2.94


Loss during Filling Filled Qty. Obtained Sealed Qty. Obtained Loss at Sealing Qty. taken for VI

Wt. % Nos % Nos % Nos % Nos %

0.5 13.03 865 72.08 865 72.08 0 0 865 72.08

0.21 6.25 927 92.7 927 92.7 0 0 927 92.7

0.2 6.07 445 99.78 445 99.78 0 0 445 99.78

0 0 142 41.64 142 41.64 0 0 142 41.64

0.15 4.48 500 87.56 500 87.56 0 0 500 87.56

0.03 922 99.14 922 99.14 0 0 922 99.14


Rejections Obtained in Visual Inspection Sampled Qty. Fill Volume

Fibers Particles Vol.Def. Seal Def. Total Nos % Min. Max

0 0 0 0 0 72.08 35 2.92 2.3 2.4

1 1 0 0 2 92.5 35 3.5 2.3 2.4

0 0 0 0 0 99.22 25 5.1 2.3 2.4

0 0 0 0 0 41.06 22 5.87 2.3 2.4

0 0 0 0 0 100 32 6.4 2.3 2.4

0 0 0 0 0 99.1 32 3.4 2.3 2.4


Fill Weight Filled Volume Filled Weight Qty. Sent for Packing
Pack
Min. Max Min. Max Min. Max Nos % Code

2.49 2.6 2.31 2.31 2.5 2.5 830 69.16 301027

300505

300505

3002722

2.49 2.59 2.24 2.4 2.22 2.6 890 89 300505

301027

301027

300505

2.48 2.59 2.34 2.35 2.53 2.54 420 94.12 300505

2.45 2.58 2.25 2.35 2.24 2.54 120 35.19 301027

3002722

300505

2.48 2.59 2.36 2.37 2.22 2.56 468 93.6 300505

301027

300505

2.47 2.57 2.35 2.37 2.52 2.54 890 95.7 3002722

300505

301027
Inner Cartons
Labels Consumed Consumed
Work Order Theoretica Expected
Market Number B.Size l Yield Yield Nos % Nos %

NCIS 400028430 0 38 98 39 97.5 39 97.5

Domestic 400027820 0 330 98 331 94.5 331 97.3

Domestic 400028776 0 401 98 402 95.71 402 98.05


NCIS(Per
u) 400028716 0 21

Domestic 400027819 0 342 98 343 95.2 343 98

NCIS. 400026590 0 28 92 29 96.66 29 96.68

NCIS. 400026885 0 19 92 20 100 20 100

Domestic 400026069 0 501 98 502 94.71 502 96.53

Domestic 400029490 0 420 98 422 95 422 98

NCIs 400029964 0 5 92 7 70 7 70
NCIs(Peru
) 400029970 0 5 7 70 6 60

Domestic 400030131 0 110 98 112 93.33 112 93.33

Domestic 400030250 0 306 98 308 96.3 308 96.3

NCIS 400030471 0 20 92 22 73.3 22 73.3

Domestic 400030807 0 142 98 144 96 144 96


NCIS(Per
u) 400030895 0 25 27 90 27 90

Domestic 400030896 0 502 98 504 95.09 504 96.92

Ncis 400030865 0 38 92
Outer Cartons Inner Cartons
Consumed Leaf lets Consumed Labels Destroyed Destroyed Outer Cartons

Nos % Nos % Nos % Nos % Nos %

0 0 39 97.5 1 2.5 1 2.5 0 0

0 0 331 97.3 19 5.5 9 2.7 0 0

0 0 402 98.05 18 4.29 8 1.95 0 0

0 0 0 0

0 0 343 98 17 4.8 7 2 0 0

0 0 29 96.66 1 3.34 1 3.34 0 0

0 0 20 100 0 0 0 0 0 0

0 0 8 98.43 28 5.29 18 3.47 0 0

0 0 421 98 18 5 8 2 0 0

0 0 6 60 3 30 3 30 0 0

0 0 6 60 3 30 4 40 0 0

0 0 112 93.33 8 6.67 8 6.67 0 0

0 0 307 99 12 3.7 12 3.7 0 0

0 0 21 70 8 26.7 8 26.7 0 0

0 0 143 95.3 6 4 6 4 0 0

0 0 26 86.7 3 10 3 10 0 0

0 0 503 98.62 26 4.91 16 3.08 0 0


Total Packed Qty. of
Leaflets Destroyed Total Packing Loss the Batch
Control
Nos % To BSR Sample Others Nos % Nos % Nos

1 2.5 37 1 38 3.17

9 2.7 325 5 330 27.5

8 1.95 400 1 401 33.41

7 2 325 17 342 342 34.2 890

1 3.34 27 1 28 2.8

0 0 18 1 19 1.9

8 1.57 335 1 165 501 50.1

9 2 408 12 420 94.17 420

4 40 4 1 5 1.5 120

4 40 4 1 5 1.5

8 6.67 100 10 110 32.36

3 1 300 6 306 53.6

9 30 19 1 20 3.5

7 4.6 137 5 142 24.86 468

4 13.3 24 1 25 2.6

7 1.38 500 2 502 53.9


Total Packed Qty. of
the Batch Total Yield Total Loss Related Substanc
Specific 2-epi
% Nos % Nos % AR NO. pH Gravity docetaxel

15223 4.42 1.08 0

89 890 89 110 11

94.17 420 94.17 26 5.83

35.19 142 41.64 199 58.36

81.96 468 81.96 103 18.03

22240 4.36 1.07 0


Related Substances
7-epi Total Extractabl
docetaxel impurities Assay AR NO pH e Vol Color >= 10u >=25u water

0 0.24 40.01 16289 4.28 2.1 0.35 2380 208 1.3

12261 4.28 2 0.3 49 3 1.1

17444 4.28 2 0.26 35 4 0.3

20932 4.25 2 0.35 109 3 1

21708 4.31 2 0.36 379 21 2.2

0 0.45 39.8 22321 4.33 2 0.37 82 3 2.3


Related Substances
2-epi 7-epi Total
docetaxel docetaxel impurities Assay

0.17 0.1 0.8 40.4

0.05 0 0.13 40.8

0 0 0.46 39.7

0.05 0.16 0.47 40.7

0.1 0 0.46 40.4

0.1 0 0.32 40.4


Product Code Work Order Number Batch Size

Sl.No. Batch No MFD EXP Bulk Finished Bulk Finished Liters

1 A5190 May.2005 Apr.2007 200690 2501215 400027305

2 A5005 Jan.2005 dec.2006 200690 2501215 400024743 400024744 3

3 A5011 Jan.2005 dec.2006 200690 2501215 400024745 400024746 3.1

4 A5260 Jul.2005 Jun.2007 200690 2501215 400028154

5 A5338 Sep.2005 Aug.2007 200690 2501215 400029503

6 A5350 Sep.2005 Aug.2007 200690 2501215 400029565 400029573 3.1

7 A5374 Oct.2005 Sep.2007 200690 2501215 400029941

8 A5401 Nov.2005 Oct.2007 200690 2501215 400030404

9 A5404 Nov.2005 Oct.2007 200690 2501215 400030442


Final pH
Batch Size after
pH of pH after Total Qty. of addition of qty. of
Theoretica Expected Polysorbat addition of quantity of Citric acid anhydrous Docetaxel
Nos Weight l Yield Yield e Citric acid Citric acid destroyed citric acid (gms)

450 450

864 3.19 864 95 4.8 4.8 5.5 0.5 4.42 132.67

846 3.19 846 90 4.25 4.8 5.25 0.75 4.8 132.56

446 446

551 551

846 3.19 846 4.5 4.87 5.25 0.5 4.48 133.4

382 382

230 230

742 742
Qty. taken for
Qty.of Bulk Sol. Bubble Point Test Filtration
Filtration
Mixing Temp. during MFG. Weight Liters time Pre Post Weight %
time min. Max.

1 20 23 3.29 3.1 2.05 3270 3.31 98.24

1 20 23 3.25 3.25 3.1 3233 3.28 97.07

1 23 23 3.33 3.11 2.15

4 3.32 99.8
Qty. of Filtrate Qty. of Bulk Sol. Calibration Loss
Obtained Filtration Loss Filled during Filling Total Filled Qty.

Weight % Wt. % Wt. % Wt. % Wt. %

0.02 0.6

3.09 91.24 0.22 6.53 2.99 88.72 0.05 1.48 3.04 90.2

3.03 89.67 0.25 2.89 85.43 0.06 1.89 2.95 87.33

0.03 0.9

0.01 0.3 3.32 86.91

2.97 89.24 0.35 10.6 2.96 88.9 0.01 0.3 2.97 89.24
Loss during Filling Filled Qty. Obtained Sealed Qty. Obtained Loss at Sealing Qty. taken for VI

Wt. % Nos % Nos % Nos % Nos %

0.26 7.77 335 74.44 335 74.44 0 0 335 74.44

0.05 1.51 846 100 846 100 0 0 846 100

0.08 2.33 815 96.33 815 96.33 0 0 815 96.33

0.2 6.07 431 96.63 431 96.63 0 0 431 96.63

551 100 551 100 0 0 551 100

0.15 4.48 332 86.91 332 86.91 0 0 332 86.91

841 99.4 841 99.4 0 0 841 99.4

175 76.1 175 76.1 0 0 175 76.1

742 100 742 100 0 0 742 100


Rejections Obtained in Visual Inspection Sampled Qty. Fill Volume

Fibers Particles Vol.Def. Seal Def. Total Nos % Min. Max

0 0 2 0 2 73.99 25 5.55 3.2 3.3

0 0 1 0 1 99.88 35 4.14 3.2 3.3

3 3 0 0 6 95.61 35 4.13 3.2 3.3

0 0 0 0 0 145.38 25 54.35 3.2 3.3

0 0 0 0 0 100.09 30 5.54 3.2 3.3

0 1 0 0 1 86.64 20 5.23 3.2 3.3

0 0 0 0 0 99.36 30 3.5 3.2 3.3

1 2 0 0 3 74.73 20 4.3 3.2 3.3

0 0 0 0 0 100 30 4.05 3.2 3.3


0
Fill Weight Filled Volume Filled Weight Qty. Sent for Packing
Pack
Min. Max Min. Max Min. Max Nos % Code

3.45 3.56 3.24 3.29 3.55 3.55 308 68.44 3000441

3.48 3.59 3.27 3.27 3.56 3.56 810 95.74 3000441

3.49 3.6 3.28 3.28 3.57 3.57 774 91.48 3000441

3.45 3.56 3.26 3.27 3.52 3.53 406 91.03 3000441

3000441

3.45 3.55 3.25 3.25 3.5 3.5 521 94.55 3000441

3000441

3.46 3.56 3.25 3.26 3.51 3.52 311 81.41 3000441

3000441

3000441

3.46 3.56 3.24 3.29 3.48 3.55 811 95.86 3000441

3.43 3.54 3.26 3.27 3.5 3.51 152 70.43 3000441

3.42 3.53 3.26 3.27 3.49 3.5 712 95.95


Inner Cartons
Labels Consumed Consumed
Work Order Theoretica Expected
Market Number B.Size l Yield Yield Nos % Nos %

Domestic 400028246 0 308 98 309 93.6 309 96.5

Domestic 400025150 0 810 98 811 95.41 811 97.71

Domestic 400025151 0 774 98 775 95.6 775 98.1

Domestic 400028778 0 335 98 336 96 336 96

Domestic 400029239 0 71 98 72 90 72 90

Domestic 400029792 0 505 98 507 95.66 507 97.5

Domestic 400030253 0 16 98

Domestic 400030808 0 300 98 302 94.37 302 97.41

Domestic 400030343 0 190 98 192 96 192 96

Domestic 400030353 0 321 98 323 95 323 97.9

Domestic 400030254 0 311 98 313 94.8 312 97.5

Domestic 400030842 0 152 98 154 96.25 154 96.25


Outer Cartons Inner Cartons
Consumed Leaf lets Consumed Labels Destroyed Destroyed Outer Cartons

Nos % Nos % Nos % Nos % Nos %

156 97.5 309 99.6 21 6.4 11 3.5 4 2.5

407 96.9 811 98.9 39 4.59 19 2.29 13 3.1

388 97 775 99.3 35 4.4 15 1.9 12 3

169 93.89 336 98.82 14 4 14 21 11 6.11

37 92.5 72 10 8 10 8 10 3 7.5

255 98.07 507 99.41 23 4.34 13 2.5 5 1.93

153 95.62 301 97.09 18 5.03 8 2.59 7 4.38

97 97 191 97 8 4 8 4 3 3

163 95.9 322 97.3 17 5 7 2.1 7 4.1

158 98.8 312 97.5 17 5.2 8 2.5 2 1.2

78 97.5 153 95.62 6 3.75 6 3.75 2 2.5


Total Packed Qty. of
Leaflets Destroyed Total Packing Loss the Batch
Control
Nos % To BSR Sample Others Nos % Nos % Nos

1 0.4 288 20 308 68.44 0 0 308

9 1.09 790 20 810 95.74 0 0 810

5 0.7 754 20 774 91.43 0 0 774

4 1.18 330 5 335 75.11 0 0

8 10 66 5 71 15.92 0 0 406

3 0.59 500 5 505 91.65 0 0

11 5 16 2.9 0 0 521

9 2.91 293 7 300 35.5 0 0 811

9 4.5 188 2 190 22.5 0 0

8 2.7 320 1 321 37.9 0 0 311

8 2.5 301 10 311 81.4 0 0

7 4.38 142 10 152 66.08 0 0 152


Total Packed Qty. of
the Batch Total Yield Total Loss Related Substanc
Specific 2-epi
% Nos % Nos % AR NO. pH Gravity docetaxel

68.44 308 68.44 142 31.56

95.74 810 95.74 36 4.26

91.48 774 91.48 72 8.51 9581 4.35 1.09

9853 4.12 1.09

91.03 406 91.03 40 8.97

521 94.55 30 5.45

94.55 20404 4.31 1.08

95.9 841 99.4 5 0.6

81.4 311 81.4 71 18.6

66.08 152 66.08 78 33.91


Related Substances
7-epi Total Extractabl Colorof
docetaxel impurities Assay AR NO pH e Vol solution >= 10u >=25u water

15880 4.22 3.1 0.35 130 14 1.4

10017 4.18 3.1 0.28 5042 482 1

41.7 10018 4.11 3.2 0.25 5248 506 0.9

4.15 41.8 17445 4.24 3.1 0.26 133 8 1.5

20933 4.22 3.2 0.36 24 1 1.2

0.14 40

20934 4.32 3.2 0.36 106 4 1.1

21709 4.28 3 0.36 295 5 1

22322 4.32 3 0.36 181 14 1.9


22742 4.36 3.1 0.36 432 37 1.6
Related Substances
2-epi 7-epi Total
docetaxel docetaxel impurities Assay

0.15 0.17 0.62 39.67

0 0 0 40.3

0.07 0 0.15 39.99

0 0 0.4 40.58

0.06 0.11 0.5 40.86

0.05 0.16 0.49 39.67

0.08 0 0.54 40.54

0.1 0 0.33 40.27


0.1 0 0.24 40.25