INTAS PHARMACEUTICALS LTD.

(INTAS) (Plasma Fractionation Centre)

Plot No. 496/1/A&B Matoda, Ahmedabad,Gujarat.
Blood Bank Information

Blood Bank Name as per

License
Bloce Centhe of New Koi<a Hagp tu
Location

License Grant Date

al-06-2023
License No. 2091-8
Vendor Code
(To be filled by INTAS)

EPIDEMIOLOGICAL DATA

Year- 2023-24 Year -2022-23 Year- 2021-22 Year-2020 -21

Testing (Apr'23 to Mar'24) (Apr'22 toMar 23) (Apr'21 to Mar'22) (Apr'20 to Mar'21l)

HIV (%)

HBsAg (%) -2

HCV (%) 62%

Note:
Kindly share details as per financial year only.
For the blank column share justification in remarks.
Avoid Use of NA, - (Dash) or Nil

BLOOD BANK INSPECTION DETAILS

Last Inspection Date Inspection Authority

(State /Central / BOTH JOINT)

Sef 2023 Bots Soint

STORAGE FACILITY & TESTING
Storage NAT
If Yes
Blast Mini If Yes
Freezer
Freezing room
(Yes/No) freezer Testing
(Yes/No) pool- or Manufacturer
(Yes/No) ID-NAT
No. of (-80 )°C No. of (-40) °C
No No NO
 INTAS PHARMACEUTICALS LTD.

(INTAS) (Plasma Fractionation Centre)

Plot No.496/1/A&B Matoda, Ahmedabad, Gujarat.
Blood Bank Information

BLOOD BAG DETAILS

Type of Bag : Double/ Triple/ Quadruple
Volume of CE
Brand name of bag Anticoagulant Specification
Manufacturer Marked
solution used (350 ml/ 450 ml) Anticoagulant
Solution (Yes/No)
62 om
yes

Plasma Apheresis (Yes/No): ye

Remarks if any:

Blood Bank Stamp:

(Authorised Signatory)
 INTAS PHARMACEUTICALS LTD. (INTAS)
Reference Format No.: FSOPPS0000LO14

Title of Format: INITLAL BLOOD CENTRE INFORMATION Page No.: I of2

Name of Blood Centre

£lecd Centhe f New kokila Hospto
Address of Blood Centre
fere zen Roay Neaa Shenpuna Rod chaukTagaeg
License No. of Blood
Centre 209 |- B
(Kindly attach License Copy)
License Grant Date 206-2023 License valid up to date 20-6f-2
Name of Blood Centre
In-Charge
Contact Person Name Herngh Kumen 404124 9838
E-mail id & Mobile No.

Details of Blood Centre:

Number of plasma deep freezer in Blood (40) No. of freezer:
Centre (S0)No. of freezer:
Plasma units storage capacity
Blast freezer contact freezer available and its
manufacturer (Not (-80) freezer) NA
Annual blood collection (In Units) Z690 uomit
Percentage componentization
Expected surplus plasma availability for
fractionation in units this year 1So to 200 teni
Blood collection bag details Volume: V50 ml or 450 ml
Brand Name: faed J. Nu
Mfg. by:
Elisa test:YSNo
Plasma testing by ELISA & Method
Method: DAutomated Manual 3Both
(Enzyme-linked immunosorbent assay)
Mfg. by : Trutteelt
Plastna testing by NAT & Method
NAT Test : Yes/No DID NAT OMinipool NAT
|(Nucleic Acid Testing) Method: DAutomated Manual CBoth
Mfg. by:
CLIA test: YesNo
Plasma testing by CLIA
Method: DAutomated Manual Both
(Chemiluminescence Immunoassay)
Mfg. by:
fFP OCryo poor plasma
Components are made from blood
CCryoprecipitate DAII

NACO Supply kit use (If Yes, Give detail) C Yes

 INTAS PHARMACEUTICALS LTD. (INTAS)
Reference Format No.: F/SOP/PS/00001/01-4
Title of Format: INITIAL BLOOD CENTRE INFORMATION Page No.: lof2

Test Kit details for virology testing for blood:

Test & Generation Generation of
Test kit name Manufacturer
Virology Kit
HIV-I& II Trugzeel
HBsAg/ HBV Tnetwet
HCV Truttweu eoere Da
Epidemiology data (1ast 03 years) :
Marker Year- 023-2924 Year Year
HIV %
HBSAg % 6.2
HCV %

Total collection
(In units)
Prior approaching to us have you given plasma to O Yes No
other company for fractionation?
If yes please give the name of company:
Self-declaration: I (We) here by certify that the information filled in this form is accurate and complete
as of the date indicated.

Blood Centre Stamp: Authorized Person Name & Sign:

For use of Intas Pharmaceuticals Ltd. only

For Q.A. Department:

Reviewed By Sign/Date
 INTAS PHARMACEUTICALS LTD (INTAS)
Reference Format No.: F/SOP/PS/00001/02-4

Title of format: BL0OD CENTRE QUALITY ASSESSMENT CHECK LIST Page No.: l of3

Name of Blood Centre

Blord centne a New Kowla Hospitl
Address of Blood Centre
Fenszpun Roat, New Sherpuna Road Chad
Blood Centre License No. & License No: 204l
Validity : Grant on: 2-06
Valid up to: 20- 06- 2028
So23
Blood Centre Authorized Person
Name & Contact details :
Harish
Email ID:
4041? 49 838
Blocbortenerokouilahospito I@mart Com
CONTROL Licensed for
Government Hospital- GH 1. Whole Human Blood IP
2 Packed Red Cells
Private Hospital- PH 3Fresh Frozen Plasma
Voluntary Organisation - V A Single Donor Plasma
3. Platelets Rich Plasma
6. Cryoprecipitate
7. Cryo Poor Plasma

Sr. Observation Remarks

Information
No. (Yes/No) (If Any)
1. Qualification, Health, Clothing and Sanitation of Staff
Yes/No
Qualified, trained and experienced technical
1.1 staff available for carrying out critical
steps?
2. EQUIPMENTS AND DETAILS:
| 2.1 Laboratory Equipment's
Refrigerator for kits & reagent storage Aes/No
2.1.1
Aes/No
Whether digital dial thermometer provided
Nes/No
2.1.2| Centrifuge
2.1.3 Water bath Xés/No

2.1.4 Incubator with thermostatic control Xes/No

2.2 Equipment for Component Preparation &Storage
2.2.1 LAF Bench Aes No
2.2.2| Refrigerated Centrifuge Aes No
INTAS PHARMACEUTICALS LTD (INTAS)
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Title of format: BLOOD CENTRE QUALITY ASSESSMENT CHECK LIST Page No.: 2 of 3
Sr. Observation Remarks
Information
No. (Yes/No) (If Any)
2.2.3| Plasma Expresser Yes /No
2.2,4 Clipper and Clips and / or dielectric sealer Yes No

2.2.5 Weighing device Yes No

Refrigerator Yes /No

2.2.6 Whether Thermograph provided Yes No

Whether Alarm device provided Aes No

Deep freezer (-40°C) & (-80°C) Yes /No
2.2.7 Whether Thermograph provided Yes No

Whether Alarm device provided Yes INo

2.2.8 Blood bags used for component separation Double/Triple/
Quadruple
3. Testing of sample:
3.1
ELISA :Antibody to HIV 1&2 Aes No
Kit detail: Trcestevel
3.2
ELISA :Antibody to HCv Aes /No
Kit detail: Taceeel
ELISA :HBS-Ag Aes No
3.3
Kit detail: Trestee
3.4 Syphilis (Rapid plasma reagin test) Kes No
Kit detail: Trufeee
Malaria Parasite
3.5 Aes No
Kit detail: Tauffre
RT-PCR/ NAT for viral markers
3.6 Yes /No
Detail:

4.GOOD MANUFACTURING PRACTICES (GMPS), STANDARD OPERATING

PROCEDURE'S (SOPS) AND DOCUMENTATION
4.1 SOP & STP are available for key process. Yes/No
Donor Records and related tests reports are
4.2 maintained / archived as per license Xes/No
requirement.
4.3 Storage temp and methods of controlling. Aes/No
4.4 Expiry date of all final products. Yes/No
 INTAS PHARMACEUTICALS LTD (INTAS)
Reference Format No.: F/SOP/PS/00001/02-4

Title of format: BLOOD CENTRE QUALITY ASSESSMENT CHECK LIST Page No.: 3 of3|

Sr. Observation Remarks

Information
No. (Yes/No) (If Any)
Quality control procedure for vendors of
4.5 their supplies, reagents (Kit, Blood Bags, Yes/No
Reagents etc.) and Storage Conditions
verification

4.6 Schedules and procedures for equipment Yes/No

maintenance and calibration.
4.7 Labeling procedures. Yes/No
4.8 Decontamination procedure in case of
spillage YesNo
4.9 Procedures for preparing plasma or FFP Xes/No
5. COLLECTION& PROCESSING:
5.1 Donor identification, screening and selection:
5.1.1 Appropriate donor identification, screening AesNo
and selection procedures in place
5.1.2 Donor records and traceability Yes/No
6. INVESTIGATION:

6.1 Any Investigation is carried out in case of Yes/No

positive result for received blood sample?
7. Do you have permission to collect Source Plasma? Yes/No
Self-declaration: I (We) here by certify that the information filled in this form is accurate and
Complete as of the date indicated, we are collecting plasma from non-professional and non-paid donors
only.
Authorized Person Sign & Stamp:

For use of Intas Pharmaceuticals Ltd. Only

Comments by Q.A. Department:

Reviewed By Sign/Date