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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 483037-103862707

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Austria confirms the following:

The manufacturer: Takeda Manufacturing Austria AG

Site address:

Benatzkygasse 2-6, Donaustadt, Vienna, 1221, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000816 / LOC-100006113

Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Investigational product) NIP-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-05-24 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/EC, Art. 80(5) of Directive 2001/82/EC and Art. 15 of Directive 2001/20/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.6 Quality control testing

1.6.4 Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.4 Biological

Manufacture of active substance. Names of substances subject to inspection:

[900000005247]Antithrombin III NF Bulk Solution(en)

[900000005249]A1PI Bulk Solution (for Aralast NP)(en)

[900000005250]Sealer Protein VH S/D Bulk Powder(en)

[900000005251]Thrombin VH S/D Bulk(en)

[900000005252]Factor VII NF Bulk Powder(en)

[900000005253]Feiba (Factor VIII Inhibitor Bypassing Activity) NF Bulk Powder(en)

[900000005254]Immunate S/D Bulk Powder(en)

[900000005255]Immunine (Factor IX) Bulk solution(en)

[900000005256]Factor IX NF Bulk Powder(en)

[900000005257]C1-Inhibitor Frozen (for internal use)(en)

[900000005248]Human Protein C Bulk Drug Substance(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Antithrombin III NF Bulk Solution

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:A1PI Bulk Solution (for Aralast NP)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Sealer Protein VH S/D Bulk Powder

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Thrombin VH S/D Bulk

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Factor VII NF Bulk Powder

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Feiba (Factor VIII Inhibitor Bypassing Activity) NF Bulk Powder

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Immunate S/D Bulk Powder

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Immunine (Factor IX) Bulk solution

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:Factor IX NF Bulk Powder

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Active Substance:C1-Inhibitor Frozen (for internal use)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

Active Substance:Human Protein C Bulk Drug Substance

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.5  Modification of extracted substance Human

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of bulk for further manufacturing in Lange Allee 24, 1221 Wien

Clarifying remarks (for public users):

Hersteller Arzneimittel: Takeda Manufacturing Austria AG; ad Punkte/ points 1.6. und/ and 2.1: Adventitious Virus Testing (AAT) Testung von rekombinanten Produkten durch die Abteilung Global Pathogen Safety (GPS)/ Adventitious Virus Testing (AAT) of recombinante Products) at t…; Hersteller Wirkstoffe: Takeda Manufacturing Austria AG; ad Punkte/ points 1.6. und/ and 2.1: Adventitious Virus Testing (AAT) Testung von rekombinanten Produkten durch die Abteilung Global Pathogen Safety (GPS)/ Adventitious Virus Testing (AAT) of recombinante Products) at t…; Hersteller klinischer Prüfpräparate: Takeda Manufacturing Austria AG; ad Punkte/ points 1.6. und/ and 2.1: Adventitious Virus Testing (AAT) Testung von rekombinanten Produkten durch die Abteilung Global Pathogen Safety (GPS)/ Adventitious Virus Testing (AAT) of recombinante Products) at t…;

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Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.