CERTIFICATE NUMBER:
483976-103731876
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1)
, (2)
Part 1
Issued following an inspection in accordance with
The competent authority of Austria confirms the following:
The manufacturer: Baxalta US Inc.
Site address:
505 Shire Parkway, Social Circle, GA, 30025-4723, United States
OMS Organisation Id. / OMS Location Id.: ORG-100011981 / LOC-100072658
Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 94(4) of Regulation (EU) 2019/6 and Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).
Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2025-02-27
, it is considered that it complies with:
The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)
The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)
The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).
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. 80(5) of Directive 2001/82/EC and Art. 111(5) of Directive 2001/83/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
Veterinary Medicinal Products
Manufacture of active substance. Names of substances subject to inspection:
[900000005242]Fraction V (Intermediate for Human Albumin)(en)
[900000005243]Human Albumin Bulk (Intermediate for Human Albumin)(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
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 Fraction V Paste intermediate for further processing at the Social Circle Facility a…
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
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 Human Albumin bulk (heat-treated) for further processing at another Takeda facility …
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.6.2 Microbiological testing excluding sterility testing
3.6.4 Biological Testing
Clarifying remarks (for public users):
