APQR R Atorvastatin 20 MG IP New1

VIDHYASHA PHARMACEUTICALS
PLOT NO.-28,IND. AREA, TRILOKPUR ROAD,KALA AMB, DISTT-

SIRMOUR (HP), 173030
REPORT No. VP/APQR/TB/ATR/005
Referance SOP No. VP/SOP/QAD/043
ANNUAL PRODUCT QUALITY REVIEW
Year 2023 REPORT
PAGE No. 1 OF 14
ANNUAL PRODUCT QUALITY

REVIEW REPORT
GENERIC NAME
Atorvastatin Tablets IP
(20 mg)
Year 2023 REPORT
PAGE No. 2 OF 14
Index
Sr. No Table of Contents Page No.
1. OBJECTIVE 4
2. PRODUCT DETAILS 4
3. REVIEW OF RAW & PACKING MATERIAL QUALITY FINDINGS 5
4. REVIEW OF CRITICAL PROCESS 5
5. % YIELD OF FINISHED PRODUCT 6
6. PHYSICAL & ANYLITICAL PARAMETER OF TABLET 8
7. REVIEW OF FINISHED PRODUCTS QUALITY FINDINGS 10
8. REVIEW OF ENVIRONMENT MONITORING FINDINGS 10
9. REVIEW OF DEVIATION 10
10. REVIEW OF CHANGE CONTROL PROPOSAL 10
11. REVIEW OF OOS (OUT OF SPECIFICATION) 10
12. REVIEW OF MARKET COMPLAINTS, PRODUCT RECALL 11
13. REVIEW OF CONTROL SAMPLES 11
14. REVIEW OF QUALIFICATION STATUS OF EQUIPMENTS & UTILITIES 11
15. CONCLUSION 12
16. ABBREVIATION 12
Year 2023 REPORT
PAGE No. 3 OF 14
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

EXECUTIVE
QUALITY ASSURANCE
REVIEWED BY:

HEAD
PRODUCTION
HEAD
QUALITY CONTROL
APPROVED BY:

HEAD
QUALITY ASSURANCE
AUTHORISED BY:
PLANT HEAD
1.0 OBJECTIVE:
Year 2023 REPORT
PAGE No. 4 OF 14
The Annual Product Quality Review in respect of Atorvastatin Tablets IP for the year 2023.The
objective of verifying the consistency of the existing manufacturing process and the appropriateness
of current Specification of both starting material & finished products.
2.0 PRODUCT DETAIL:
A) COMPOSITON:
Each film coated tablet contains:
Atorvastatin Calcium IP
Eq. to Atorvastatin 20 mg
Excipients q.s.
Approved colour to be used.
B) LICENSE No.:
The Product license No. is N-MNB/14/146 & N-MB/14/147
C) PRODUCT SHELF LIFE:

The Product Shelf Life is 24 months.
D) PACK SIZE:
The product pack style is (100x10x10Tablets)
E) STANDARD BATCH SIZE:

The Product Standard Batch Size is 1.0 Lac tablets
F) OVERAGES
Atorvastatin calcium IP 20 mg
3.0 REVIEW OF RAW & PACKING MATERIAL QUALITY FINDINGS:

Year 2023 REPORT
PAGE No. 5 OF 14
All Raw & Packing material for manufacturing and packing should be purchase from
approved vendor and well within established in respect to quality attributes.
Vendor Detail for RM (API)

Sr. No. Name of API Name of Vendor
01 Atorvastatin calcium IP Reine Life Sciences
Vendor Detail for Primary Packing Material

Sr. No. Name of PM Name of Vendor
01 Alu printed Foil Gunina print pack
02 Alu. Base Foil Darbari Enterprises
4.0 REVIEW OF CRITICAL PROCESS-

The Critical process parameters i.e. Dispensing, Manufacturing, Blending, Compression,
Coating & Packing should be comply as per BMR and approved specifications. During
packing leak test should be confirm. In process control carried out during manufacturing
according to specification in respect to quality attributes.
A) Detail of No. of batches

Total 12 batches taken during review period.
B) Packing Style of the product

C) The packing style of the product is 10 tablets packed in Alu. base Foil / printed
aluminum. foil and 10 ALU/ALU packed in a printed unit carton and such 100 cartons
packed in 7 ply corrugated box.
Year 2023 REPORT
PAGE No. 6 OF 14
D) The Detail of batches as Batch No., Mfg. Date, Exp. Date, Batch Size & packing Style to
be given table and graph representation.
These following batches of Atorvastatin Tablets IP taken for the year 2023.
S. No. Product Name Batch No. Mfg Date Exp. Date Batch Size
1. ATR-20 Tablet VDT-23033 JAN.-2023 DEC-2025 4,00,000 Tablets
2. ATR-20 Tablet VDT-23194 FEB.-2023 JAN-2025 2,00,000 Tablets
3. ATR-20 Tablet VDT-23245 MAR.-2023 FEB-2025 1,00,000 Tablets
4. ATR-20 Tablet VDT-23253 MAR.-2023 FEB-2025 4,00,000 Tablets
5. ATR-20 Tablet VDT-23402 MAY.-2023 APR-2025 3,00,000 Tablets
6. ATR-20 Tablet VDT-23490 JUN.-2023 MAY-2025 2,00,000 Tablets
Atorvatin-20
7. VDT-23597 JUL-2023 JUN-2025 3,00,000 Tablets
Tablet
8. ATR-20 Tablet VDT-23681 AUG-2023 JUL-2025 2,00,000 Tablets
9. ATR-20 Tablet VDT-23870 SEP-2023 AUG-2025 4,00,000 Tablets
10. ATR-20 Tablet VDT-231057 NOV-2023 OCT-2025 2,00,000 Tablets
11. ATR-20 Tablet VDT-231161 NOV-2023 OCT-2025 3,82,000 Tablets
12. ATR-20 Tablet VDT-231199 DEC.-2023 NOV-2025 2,00,000 Tablets
5.0 % YIELD:
The yield status is given below for Atorvastatin Tablets IP.
S. No. Product Name Batch No. % Yield (NLT 97.0 %)

1. ATR-20 Tablet VDT-23033 98.5
2. ATR-20 Tablet VDT-23194 98.3
3. ATR-20 Tablet VDT-23245 97.9
4. ATR-20 Tablet VDT-23253 98.3
5. ATR-20 Tablet VDT-23402 98.6
6. ATR-20 Tablet VDT-23490 98.1
Year 2023 REPORT
PAGE No. 7 OF 14
7. Atorvatin-20 Tablet VDT-23597 97.9

8. ATR-20 Tablet VDT-23681 98.2
9. ATR-20 Tablet VDT-23870 98.4
10. ATR-20 Tablet VDT-231057 98.5
11. ATR-20 Tablet VDT-231161 98.3
12. ATR-20 Tablet VDT-231199 97.9
Min 97.9
Max 98.6
Average 98.24
STD 0.246644143
% Yield (NLT 97.0 %)

100
99.5
Observed Yield
99
98.5
98
97.5
97
33 94 45 53 02 90 97 81 70 57 61 99
30 231 232 232 234 234 235 236 238 310 311 311
%
2
T- T- T- T- T- T- T- T- T- -2 -2 -2
VD VD VD VD VD VD VD VD VD VDT VDT VDT
Batch Number
PROCESS CAPABILITY STUDIES (Cp & Cpk) FOR BATCH YIELD -
USL for Batch Yield 100.00

LSL for Batch Yield 97.00
Year 2023 REPORT
PAGE No. 8 OF 14
Mean for Batch Yield 98.24

Sd of Batch Yield 0.246644143
i. Cp- Cp is used to evaluate the variation of process. The Cp value for the batch yield
is as follows:-
Process Capability (Cp)=
Cp = USL –LSL/6Sd
Cp = 100.00-97.00/6*0.246644143
Cp = 2.027
ii. Cpk- Cpk is used to evaluate the centering the process. The Max. Cpk value & the Min.
Cpk values for the batch yield are as follows:-
Process Capability Cpk (Max.) = USL-Mean/3Sd
Cpk (Max) = 100.00-98.24/3*0.246644143
Cpk (Max) = 2.378
Process Capability Cpk (Min.) = Mean – LSL/3Sd

Cpk (Min.) = 98.24-97.00/3*0.246644143
Cpk(Min.) = 1.675
iii. Acceptance Criteria- If Process Capability > (greater than) 1.33 process is Highly Capable
process, If process is = (equal)1.00 to 1.33 process is Normal Capable process, and if process
capability is < (Smaller than) 1.00 Process is incapable process.
6.0 PHYSICAL & ANYLITICAL PARAMETER OF TABLET:

Fill the parameters for finished products in given table and draw the results in graph.
Description of tablet
(White coloured
Average Wt. Assay
S. Round shaped Dissolution
Batch No. (195 mg/tab ± (19 mg to 21
No. biconvex Film coated NLT 75 %
5.0%) mg)
tablet having Plain on
both side)
1. VDT-23033 Complies 197.9 99.8 20.16
Year 2023 REPORT
PAGE No. 9 OF 14
2. VDT-23194 Complies 191.0 95.3 19.60

3. VDT-23245 Complies 194.0 99.4 20.05
4. VDT-23253 Complies 194.0 97.1 19.97
5. VDT-23402 Complies 188.7 96.1 19.85
6. VDT-23490 Complies 191.9 97.8 19.66
7. VDT-23597 Complies 194.5 97.9 19.63
8. VDT-23681 Complies 189.0 97.4 19.73
9. VDT-23870 Complies 193.7 91.3 19.53
10. VDT-231057 Complies 192.6 90.8 19.65
11. VDT-231161 Complies 196.5 97.5 19.59
12. VDT-231199 Complies 190.8 96.5 19.67
Minimum 188.7 90.80 19.53
Maximum 197.9 99.80 20.16
Average 192.88 96.40 19.75
PROCESS CAPABILITY STUDIES (Cp & CPk) FOR BATCH ASSAY -
USL for Batch Assay 21.00

LSL for Batch Assay 19.00
Mean for Batch Assay 19.75
SD of Batch Assay 0.202624821
i. Cp- Cp is used to evaluate the variation of process. The Cp value for the batch
assay is as follows:-
Process Capability (Cp)=
Cp = USL –LSL/6Sd
Cp = 21-19/6*0.202624821
Cp = 1.645
ii. Cpk- Cpk is used to evaluate the centering the process. The Max. Cpk value & the
Min. Cpk values for the batch assay are as follows:-
Year 2023 REPORT
PAGE No. 10 OF 14
Process Capability Cpk (Max.) = USL-Mean/3Sd

Cpk (Max) = 21-19.75/3*0.202624821
Cpk (Max) = 2.056
Process Capability CPk (Min.) = Mean – LSL/3Sd

Cpk (Min.) = 19.75-19.00/3*0.202624821
Cpk(Min.) = 1.233
iii. Acceptance Criteria- If Process Capability > (greater than) 1.33 process is Highly Capable process,
If process is = (equal)1.00 to 1.33 process is Normal Capable process, and if process capability is <
(Smaller than) 1.00 Process is incapable process.
Avg. weight (195 mg)

198
196
194
192
(Avg. Weight in mg)
190
188
186
184
VDT- VDT- VDT- VDT- VDT- VDT- VDT- VDT- VDT- VDT- VDT- VDT-
23033 23194 23245 23253 23402 23490 23597 23681 23870 231057 231161 231199
Batch
Batch Number
Number
Year 2023 REPORT
PAGE No. 11 OF 14
Dissolution NLT 75 % (D)

100
Observed Dissolution
98
96
94
92
90
88
86
3 4 5 3 2 0 7 1 0 7 1 9
3 03 3 19 3 24 3 25 3 40 3 49 3 59 3 68 3 87 1 05 1 16 1 19
2 2 2 2 2 2 2 2 2 23 23 23
T- T- T- T- T- T- T- T- T- T- T- T-
VD VD VD VD VD VD VD VD VD V D V D V D
Batch Number
Assay (19 mg to 21 mg)
20.2
(Observed As-
20
19.8
19.6
19.4
say)
19.2
03
3
19
4
24
5
25
3
40
2
49
0
59
7
68
1 70 57 61 99
3 3 3 3 3 3 3 3 38 3 10 3 11 3 11
T-2 T-2 T-2 T-2 T-2 T-2 T-2 T-2 T-
2 2 2 2
VD VD VD VD VD VD VD VD VD DT- DT- DT-
V V V
Batch Number
7.0 REVIEW OF FINISHED PRODUCTS QUALITY FINDINGS:

The quality parameters reviewed for finished products were Description, Avg. weight,
Dissolution, Assay and chemical analysis found well with in specification as per FG COA.
Year 2023 REPORT
PAGE No. 12 OF 14
8.0 REVIEW OF ENVIRONMENT MONITORING FINDINGS:

All Environment monitoring parameters like Pressure Differential, Temperature, Relative
Humidity, Non Viable count of Air & Viable count of Air, Surface & Personnel were found
well with in specification.
9.0 REVIEW OF DEVIATION:

There was no deviation found in during review period.
10.0 REVIEW OF CHANGE CONTROL PROPOSAL:

There was no change controls found in the batches during review period.
11.0 REVIEW OF OOS (OUT OF SPECIFICATION):

There was no out of specification observed during review period.
12.0 REVIEW OF MARKET COMPLAINTS, PRODUCT RECALL:

There were no market complaints / product recall received.
13.0 REVIEW OF CONTROL SAMPLES:

All control sample checks & found satisfactory.
14.0 REVIEW OF QUALIFICATION STATUS OF EQUIPMENT & UTILITIES:

Scheduled Re-qualification Status of Critical equipment & utilities are completed & found
satisfactory. All equipments work well and do not have any adverse impact on aseptic
process.
S. No Equipment and Utility Name Qualification Status
1. HVAC Scheduled requalification completed and found satisfactory.

Trend of environment condition of area / quality attributes of
air provided by system found well within the acceptable limit.
2. Compressed Air Scheduled requalification completed and found satisfactory.
Trend of quality attributes of air provided by system found
Year 2023 REPORT
PAGE No. 13 OF 14
well within the acceptable limit

3. Water System Scheduled requalification completed and found satisfactory.
Trend of quality attributes of purified water found well within
the acceptable limit.
4. Vibratory sifter Scheduled requalification completed and found satisfactory.
5. Blender Scheduled requalification completed and found satisfactory.
6. Paste kettle Scheduled requalification completed and found satisfactory.
7. RMG Scheduled requalification completed and found satisfactory.
8. Multi mill Scheduled requalification completed and found satisfactory.
9. FBD Scheduled requalification completed and found satisfactory.
10. Compression machine Scheduled requalification completed and found satisfactory.
11. Coating pan Scheduled requalification completed and found satisfactory.
12. Alu-Alu machine Scheduled requalification completed and found satisfactory.
15.0 CONCLUSION:
All the process parameters, in process check and finished product quality attributes were observed
with in the specified limits and showing consistent results. Hence, the product quality and process
Performance found satisfactory.
16.0 ABBREVIATION:
VP: Vidhyasha Pharmaceuticals

APR: Annual Product Review
TB: Tablet
ATR: Atorvastatin
RM: Raw Material
PM: Packing Material
API: Active Pharmaceuticals Ingredient
ML: Milliliter
Year 2023 REPORT
PAGE No. 14 OF 14
M/C: Machine
HVAC: Heating Ventilation Air Condition
QAD: Quality Assurance Department

APQR R Atorvastatin 20 MG IP New1

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VIDHYASHA PHARMACEUTICALS

PLOT NO.-28,IND. AREA, TRILOKPUR ROAD,KALA AMB, DISTT-

ANNUAL PRODUCT QUALITY

Sr. No Table of Contents Page No.

3. REVIEW OF RAW & PACKING MATERIAL QUALITY FINDINGS 5

4. REVIEW OF CRITICAL PROCESS 5

5. % YIELD OF FINISHED PRODUCT 6

6. PHYSICAL & ANYLITICAL PARAMETER OF TABLET 8

7. REVIEW OF FINISHED PRODUCTS QUALITY FINDINGS 10

8. REVIEW OF ENVIRONMENT MONITORING FINDINGS 10

10. REVIEW OF CHANGE CONTROL PROPOSAL 10

11. REVIEW OF OOS (OUT OF SPECIFICATION) 10

12. REVIEW OF MARKET COMPLAINTS, PRODUCT RECALL 11

13. REVIEW OF CONTROL SAMPLES 11

14. REVIEW OF QUALIFICATION STATUS OF EQUIPMENTS & UTILITIES 11

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

2.0 PRODUCT DETAIL:

C) PRODUCT SHELF LIFE:

E) STANDARD BATCH SIZE:

3.0 REVIEW OF RAW & PACKING MATERIAL QUALITY FINDINGS:

Vendor Detail for RM (API)

Vendor Detail for Primary Packing Material

4.0 REVIEW OF CRITICAL PROCESS-

A) Detail of No. of batches

B) Packing Style of the product

S. No. Product Name Batch No. % Yield (NLT 97.0 %)

7. Atorvatin-20 Tablet VDT-23597 97.9

% Yield (NLT 97.0 %)

PROCESS CAPABILITY STUDIES (Cp & Cpk) FOR BATCH YIELD -

USL for Batch Yield 100.00

Mean for Batch Yield 98.24

Cpk (Max) = 2.378

Process Capability Cpk (Min.) = Mean – LSL/3Sd

6.0 PHYSICAL & ANYLITICAL PARAMETER OF TABLET:

2. VDT-23194 Complies 191.0 95.3 19.60

PROCESS CAPABILITY STUDIES (Cp & CPk) FOR BATCH ASSAY -

USL for Batch Assay 21.00

Process Capability Cpk (Max.) = USL-Mean/3Sd

Cpk (Max) = 2.056

Process Capability CPk (Min.) = Mean – LSL/3Sd

Avg. weight (195 mg)

Dissolution NLT 75 % (D)

Assay (19 mg to 21 mg)

7.0 REVIEW OF FINISHED PRODUCTS QUALITY FINDINGS:

8.0 REVIEW OF ENVIRONMENT MONITORING FINDINGS:

9.0 REVIEW OF DEVIATION:

10.0 REVIEW OF CHANGE CONTROL PROPOSAL:

11.0 REVIEW OF OOS (OUT OF SPECIFICATION):

12.0 REVIEW OF MARKET COMPLAINTS, PRODUCT RECALL:

13.0 REVIEW OF CONTROL SAMPLES:

14.0 REVIEW OF QUALIFICATION STATUS OF EQUIPMENT & UTILITIES:

S. No Equipment and Utility Name Qualification Status

1. HVAC Scheduled requalification completed and found satisfactory.

well within the acceptable limit

VP: Vidhyasha Pharmaceuticals

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