CAPACITY ASSESSMENT INSPECTION REPORT OF M/S GT PHARMA (Pvt.) Ltd.

General Information

Name of manufacturer M/s. GT Pharma (Pvt.) Ltd

Physical Address
DML No.
Date of inspection
Purpose of inspection
Sundar Industrial estate raiwind road la
000829
Assessment and confirmation of manufacturing capacity with
reference to DRAP, Islamabad letter No.

Dosage Form/Sections i. General Injection

Included ii. General Sachet
iii. General Capsule
iv. General Suspension
Name of inspector (s) i.

Name of Firm’s
Representative (s)
accompanying during
inspection

Manufacturing and testing record/data was evaluated from January 2022 to December 2022
for the said purpose. The details of capacity calculations are as under:

NUMBER OF PRODUCTS MANUFACTURED BY THE FIRM

Category No of products registered No of products registered for Total

for self-manufacturing contract manufacturing
General Injection/Vial 24 No 24
General Capsule 20 No 20
General sachet 8 No 8
General Dry powder 12 No 12
Suspension
Total products 68 68

SECTION WISE MANUFACTURING CAPACITY

1. (A)CAPACITY OF GENERAL INJECTION (VIAL) SECTION

Step wise capacity of Vial manufacturing Maximum production Capacity (vials)

Per day Per month
(8 hour working shift) (22 working days)
Vial Washing -
4000Vial (100ml) 88000
Per single shift of 8 working hours (Load per Day)
Depyrogenation Capacity-
3000 Vial 66000
Per Single shift of 8 working hours (Load per Day)
Filling and Sealing Capacity –
6000 Vial 132000
Per single shift of 8 working hours (Load per Day)
Packing Capacity –
6000 Vial 132000
Per single shift of 8 working hours (Load per Day)
Note: Limiting step in this process is Depyrogenation for calculating Utilized Capacity.

Quarter Wise capacity utilized in Vial manufacturing Section

Actual
Capacity Capacity
Quarter Production
(Vials) utilized in (%)
(Vials)
I (1st January – 31st March 2022) 0 264000 0
II (1st April – 30th June 2022) 42000 264000 15.90%

III (1st July – 30th September 2022) 18000 264000 6.81%

IV (1st October – 31st December 2022) 26000 264000 9.84%

Average Capacity Utilized for January – December 2022 in % 8.13%

Manufacturing Capacity Utilized (average): 8.13%

Manufacturing Capacity Available (average): 91.86%

(B)CAPACITY OF INJECTION SECTION

Step wise capacity of Injection manufacturing Maximum production Capacity (vials)

Per day Per month
(8 hour working shift) (22 working days)
Ampoule Washing -
60,000 Ampoules 1320000
Per single shift of 8 working hours (Load per Day)
Depyrogenation Capacity-
60,000 Ampoules 1320000
Per Single shift of 8 working hours (Load per Day)
Filling and Sealing Capacity –
60,000 Ampoules 1320000
Per single shift of 8 working hours (Load per Day)
Packing Capacity –
50,000 Ampoules 1100000
Per single shift of 8 working hours (Load per Day)

Note: Limiting step in this process is d Packing for calculating Utilized Capacity.

Quarter Wise capacity utilized in Injection Section

Actual
Capacity Capacity
Quarter Production
(Ampoules) utilized in (%)
(Ampoules)
I (1st January – 31st March 2022) 1900000 3960000 47.97%
II (1st April – 30th June 2022) 1000000 3960000 25.25%

III (1st July – 30th September 2022) 1000000 3960000 25.25%

IV (1st October – 31st December 2022) 1300000 3960000 32.82%
Average Capacity Utilized for January – December 2022 in % 32.82%

Manufacturing Capacity Utilized (average): 32.82%

Manufacturing Capacity Available (average): 67.17%
2. CAPACITY OF DRY POWDER FOR SUSPENSION SECTION

Step wise capacity of Dry Powder Suspension Maximum production Capacity (Bottles)
manufacturing Per day Per month
(8 hour working shift) (22 working days)
Manufacturing capacity (Large Cone Mixer)-
400 KG 4400 KG
Per single shift of 8 working hours (Load per Day)
Decartoning and Bottle Blowing Capacity-
5500 121000
Per Single shift of 8 working hours (Load per Day)
Filling and Sealing Capacity –
5500 121000
Per single shift of 8 working hours (Load per Day)
Printing Capacity for U/C
48000 U/C 1056000 U/C
Per single shift of 8 working hours (Load per Day)
Printing Capacity for labels
64000 1408000
Per single shift of 8 working hours (Load per Day)
Labeling Capacity
15000 330000
Per single shift of 8 working hours (Load per Day)
Packing Capacity –
Per single shift of 8 working hours (Load per Day) 15000 Packs 330000 Packs
with 7 workers

Note: Limiting step in this process is filling and sealing for calculating Utilized Capacity.

Quarter Wise capacity utilized in Dry Powder for Suspension Section

Actual
Capacity Capacity
Quarter Production
(Bottles) utilized in (%)
(Bottles)
I (1st January – 31st March 2022) 57300 363000 15.78%
II (1st April – 30th June 2022) 21700 363000 5.9%

III (1st July – 30th September 2022) 140240 363000 38.63%

IV (1st October – 31st December 2022) 238302 363000 65.64%

Average Capacity Utilized for January – December 2022 in % 31.48%

Manufacturing Capacity Utilized (average): 31.48%

Manufacturing Capacity Available (average): 68.51%
3. CAPACITY OF CAPSULE SECTION

Step wise capacity of Capsule manufacturing Maximum production Capacity

Per day Per month
(8 hour working shift) (22 working days)
Mixing Capacity -
100kg 2200Kg
Per single shift of 8 working hours (Load per Day)
Filling Capacity –
70,000 capsules 1540000 capsules
Per single shift of 8 working hours (Load per Day)
Blistering Capacity –
120000 capsules 2640000 capsules
Per single shift of 8 working hours
Packing Capacity –
120000 capsules 2640000 capsules
Per single shift of 8 working hours

Note: Limiting step in this process is filling for calculating Utilized Capacity.
Quarter Wise capacity utilized in Capsule Section
Actual
Capacity Capacity
Quarter Production
(Capsules) utilized in (%)
(Capsules)
I (1st January – 31st March 2022) 803318 7920000 10.14%
II (1 April – 30 June 2022)
st th
758318 7920000 9.5%
III (1st July – 30th September 2022) 476159 7920000 6.012%
IV (1st October – 31st December 2022) 1039559 7920000 13.12%
Average Capacity Utilized for January – December 2022 in % 9.69%

Manufacturing Capacity Utilized (average): 9.69%

Manufacturing Capacity Available (average): 90.31%

4. CAPACITY OF SACHET SECTION

Step wise capacity of Sachet Manufacturing Maximum production Capacity (vials)

Area Per day Per month
(8 hour working shift) (22 working days)
Manufacturing Capacity -
400 KG 8800 Kg
Per single shift of 8 working hours (Load per Day)
Ribbon Mixer Capacity ---
200 Kg 4400 Kg
Per single shift of 8 working hours (Load per Day)
Tray Dryer Drying Capacity-
130 Kg 2860 Kg
Per Single shift of 8 working hours (Load per Day)
Filling and Sealing Capacity –
400000 Sachet 880000 Sachet
Per single shift of 8 working hours (Load per Day)
Sorting Capacity ----
35000 Sachet 770000 Sachet
Per single shift of 8 working hours (Load per Day)
Packing Capacity –
100000 Sachet 220000 Sachet
Per single shift of 8 working hours (Load per Day)
Note: Limiting step in this process is packing for calculating Utilized Capacity.
Quarter Wise capacity utilized in SACHET Section
Actual
Capacity Capacity
Quarter Production
(Sachets)) utilized in (%)
(Sachets)
I (1st January – 31st March 2022) 656790 2640000 24.87%
II (1st April – 30th June 2022) 1116517 2640000 42.29%

III (1st July – 30th September 2022) 1176992 2640000 44.58%

IV (1st October – 31st December 2022) 1041438 2640000 39.44%

Average Capacity Utilized for January – December 2022 in % 37.79%
Manufacturing Capacity Utilized (average): 37.79%
Manufacturing Capacity Available (average): 62.20%

CAPACITY OF QUALITY CONTROL DEPARTMENT

Quality Control Equipment Detail

Sr. No Equipment Qty. Capacity per day
(tests)
1. HPLC 3 02x3=6
2. UV Spectrophotometer 1 15
3. pH Meter 1 50
4. Conductivity meter 1 50
5. Polarimeter 1 15
6. Dissolution Apparatus 1 06
7. Balance 2 80x2=160
8. Moisture Analyzer 1 20
9. Melting Point Apparatus 1 25
10. Karl Fischer 1 15
11. FTIR 1 50
12. Refractometer 1 50
13. Leakage test 1 15
14. Cold Incubator 1 300L
15. Hot Incubator 1 300L
16. Filtration Assembly 3 06x3=18
17. Stability Chamber 1 1000L
(Accelerated)
18. Stability Chamber 1 1500L
(Accelerated)
19. Stability Chamber (Real time) 1 400L
20. Stability Chamber (Real time) 1 1000L
The details of the total registered products of the firm with respect to the method of testing is
provided below:
 Total No of No of Products No of Products No of product No of products
registered with official with currently on to be shifted to
Products Monograph In-house/Innovat HPLC HPLC
(USP/BP/JP) or specs
67 26USP 30 36/ 67 currently NA
01 JP
05 BP
05 Ph.I

HPLC Capacity Calculation Quarter Wise

(Average 02 tests/day/HPLC)
TOTAL 03 HPLC
Average testing Capacity
Raw material Product Stability Total
Quarter capacity / utilized
tests tests tests tests
Quarter (%)
I (1st Jan – 31st Mar
2022)
396 6 48 63 117 29.54%
II (1st Apr – 30th June 396
2022)
6 39 72 117 29.54%
III (1st July – 30th Sept 396
2022)
07 70 59 136 34.34%
IV (1st Oct – 31st Dec 396
2022)
15 90 58 163 41.16%
Average capacity
HPLC Testing Capacity Utilized (average): 33.645 %
HPLC Testing Capacity Available (average): 66.355%

UV Spectrophotometer Capacity Calculation Quarter Wise

(Average 15 tests/day)
TOTAL 01 UV
Average testing Capacity
Raw material Product tests Stability Total
Quarter capacity / utilized
tests (Dissolution) tests tests
Quarter (%)
I (1st Jan – 31st Mar
2022)
990 NA 13 22 35 3.53%
II (1st Apr – 30th June
2022)
990 NA 22 33 55 5.55%
III (1st July – 30th
Sept 2022)
990 NA 9 5 14 1.41%
IV (1st Oct – 31st Dec
2022)
990 1 13 21 34 3.43%
Average capacity 3.48%

UV Testing Capacity Utilized (average): 3.48 %

UV Testing Capacity Available (average): 96.52%

Dissolution Capacity Calculation Quarter Wise

(Average 05 tests/day)
TOTAL 01 DISSOLUTION
Quarter Average Raw Product Stability Total Capacity
 capacity / material utilized
tests tests tests
Quarter tests (%)
I (1st Jan – 31st Mar
2022)
330 NA 13 28 41 12.42%
II (1st Apr – 30th June
2022)
330 NA 14 33 47 14.24%
III (1st July – 30th
Sept 2022)
330 NA 11 27 38 11.51%
IV (1st Oct – 31st Dec
2022)
330 NA 37 31 04 20.60%
Average capacity 14.69%

Dissolution Testing Capacity Utilized (average): 14.69 %

Dissolution Testing Capacity Available 85.31 %
(average):

Sterility Testing Capacity Calculation Quarter Wise

(Average 05 tests/day)
Average capacity/ Test Capacity
Quarter
Quarter Performed Utilized %
I (1st Jan – 31st Mar 2022) 330 40 12.12%
II (1 Apr – 30 June 2022)
st th
330 48 11.81%
III (1st July – 30th Sept 2022) 330 56 16.96%
IV (1st Oct – 31st Dec 2022) 330 54 16.36%
Average capacity available: 14.3125%

Sterility Testing Capacity Utilized (average): 14.3125%

Sterility Testing Capacity Available (average): 85.68%

Bacterial Endotoxin Test Capacity Calculation Quarter

Wise (Average 10 tests / day)
Average capacity/ Test Capacity
Quarter
Quarter Performed Utilized %
I (1st Jan – 31st Mar 2020) 660 111 16.81%

II (1st Apr – 30th June 2020) 660 114 17.27%

III (1st July – 30th Sept 660 90 13.63%
2020)
IV (1st Oct – 31st Dec 2020) 660 140 21.21%
Average capacity available: 17.23%

BET Testing Capacity Utilized (average): 17.23 %

BET Testing Capacity Available (average): 82.77 %

Hot and Cold Incubator Testing Capacity

The testing capacity of hot and cold incubators was determined at maximum production load during the
study period i.e., January – December 2022.
 HOT INCUBATOR
Item Media capacity Media used for testing Capacity Capacity
at a time for (Maximum production utilized (%) Available
incubation load) (%)
Test
Media bottles 112 11 9.8 % 90.2 %
Media plates 156 30 19.23 % 80.76 %
Pre-Incubated
Item Maximum Maximum incubated Capacity Capacity
capacity utilized (%) Available
(%)
Media bottles 90 18 20% 80%
Media plates 80 32 40% 60%
COLD INCUBATOR
Item Media capacity Media used for testing Capacity Capacity
at a time for (Maximum production utilized (%) Available
incubation load) (%)
Test
Media bottles 112 11 9.8 % 90.2 %
Media plates 156 30 19.23 % 80.76 %
Pre-Incubated
Item Maximum Maximum incubated Capacity Capacity
capacity utilized (%) Available
(%)
Media bottles 90 18 20% 80%
Media plates 80 16 20% 80%

Observations by the Inspection Panel:

CONCLUSION

ANNEXURES:
Annexure 1  Total number of registered products of the firm,
 Total number registered product for each aforementioned section
 Existing registered products on contract manufactured by the firm in
aforementioned sections
Annexure 2  List of all quality control equipment along with its testing capacity
 Total number of QC, IPQC and stability study tests performed in each quarter
Annexure 3  List of qualified personnel working in production, Quality control and Quality
assurance department
Annexure 4  List of production equipment along with capacity
Annexure 5  List of all production batches of each product manufactured in each quarter from
January to December 2022.
Annexure 6  Calibration certificate of cephalosporin dryer and autoclave
Annexure 7  Invoice, specifications and pictures (taken during inspection) of the newly
purchased hot incubator