CERTIFICATE NUMBER:
482009-101919969
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: Polymun Scientific Immunbiologische Forschung GmbH
Site address:
Donaustrasse 99, Klosterneuburg, Lower Austria, 3400, Austria
OMS Organisation Id. / OMS Location Id.: ORG-100009761 / LOC-100018022
Other(Human) API-A80(1)-D2001/82/EC,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC
(Veterinary) NIP-A44-D2001/82/EC
(Investigational product) NIP-A13-D2001/20/EC
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2021-05-27
, 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.
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(1) The certificate referred to in paragraph Art. 15 of Directive 2001/20/EC, 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
Human Investigational Medicinal Products
Veterinary Medicinal Products
1 MANUFACTURING OPERATIONS
1.1 Sterile products
1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.3 Batch certification
1.2 Non-sterile products
1.2.1 Non-sterile products (processing operations for the following dosage forms)
1.2.2 Batch certification
1.3 Biological medicinal products (list of product types)
1.3.1 Biological medicinal products (list of product types)
1.3.2 Batch Certification (list of product types)
1.4 Other products or manufacturing activity
1.4.1 Manufacture of
1.5 Packaging
1.5.1 Primary Packaging
1.5.2 Secondary packaging
1.6 Quality control testing
1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical
1.6.4 Biological
2 IMPORTATION OF MEDICINAL PRODUCTS
2.1 Quality control testing of imported medicinal products
2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical
2.1.4 Biological
Manufacture of active substance. Names of substances subject to inspection:
[900000005420]recombinant proteins and enzymes(en)
[900000005419]monoclonal antibodies(en)
[900000005417]recombinant human erythropoietin (C4C2)(en)
[900000005418]recombinante human follicle-stimulating hormone (rhFSH)(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
3.3
Manufacturing of Active Substance using Biological Processes
3.3.1 Fermentation
3.3.2 Cell Culture:mammalian
3.3.3 Isolation / Purification
3.3.4 Modification
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.6.2 Microbiological testing excluding sterility testing
3.6.4 Biological Testing
3.3
Manufacturing of Active Substance using Biological Processes
3.3.1 Fermentation
3.3.2 Cell Culture:mammalian
3.3.3 Isolation / Purification
3.3.4 Modification
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.6.2 Microbiological testing excluding sterility testing
3.6.4 Biological Testing
3.3
Manufacturing of Active Substance using Biological Processes
3.3.1 Fermentation
3.3.2 Cell Culture:mammalian
3.3.3 Isolation / Purification
3.3.5 Other:Zelltyp / cell type CHO
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.6.2 Microbiological testing excluding sterility testing
3.6.4 Biological Testing
3.3
Manufacturing of Active Substance using Biological Processes
3.3.1 Fermentation
3.3.2 Cell Culture:mammalian
3.3.3 Isolation / Purification
3.3.5 Other:Zelltyp / cell type CHO
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)
3.6
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):
