CERTIFICATE NUMBER:
482350-102463478
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: Pichem Forschungs-Und Entwicklungs GmbH
Site address:
Parkring 3, Grambach, Raaba-Grambach, Styria, 8074, Austria
OMS Organisation Id. / OMS Location Id.: ORG-100012356 / LOC-100023120
Other(Human) API-A123(6)-R2019/6/EU,API-A111(1)-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
2024-05-08
, 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. 111(5) of Directive 2001/83/EC, Art. 15 of Directive 2001/20/EC and Art. 80(5) of Directive 2001/82/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
1.1.3 Batch certification
1.2 Non-sterile products
1.2.2 Batch certification
1.3 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
1.6 Quality control testing
1.6.3 Chemical/Physical
2 IMPORTATION OF MEDICINAL PRODUCTS
2.2 Batch certification of imported medicinal products
2.2.1 Sterile products
2.2.2 Non-sterile products
2.2.3 Biological medicinal products
Manufacture of active substance. Names of substances subject to inspection:
[900000005554]Chemisch modifizierte Peptid-Proteinkonjugate / chemically modified peptide- protein-conjugates(en)
[900000005429]peptide-keyhole limpet hemocyanin (KLH)- conjugates and peptide-protein-conjugates(en)
[900000005556]Synthetische Peptide, chemisch modifizierte Peptide bzw. Peptidkonjugate / Synthetic peptides, chemically modified peptides and peptide conjugates(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.1 Manufacture of active substance intermediates
3.1.2 Manufacture of crude active substance
3.1.3 Salt formation / Purification steps:Saltformation
3.1.4 Other:chemische Modifizierung bzw. Kupplung / Chemical modification resp. coupling
3.5
General Finishing Steps
3.5.1 Physical processing steps:Filtration, Lyophilisation, Aliquotierung / Filtration, lyophilisation, aliquotation
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.1 Manufacture of active substance intermediates
3.1.2 Manufacture of crude active substance
3.1.3 Salt formation / Purification steps:Saltformation
3.1.4 Other:chemische Modifizierung bzw. Kupplung / Chemical modification resp. coupling
3.5
General Finishing Steps
3.5.1 Physical processing steps:Filtration, Lyophilisation, Aliquotierung / Filtration, lyophilisation, aliquotation
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.1 Manufacture of active substance intermediates
3.1.2 Manufacture of crude active substance
3.1.3 Salt formation / Purification steps:-
3.1.4 Other:Chemical modification resp. coupling
3.5
General Finishing Steps
3.5.1 Physical processing steps:Filtration, Lyophilisation, Aliquotierung / Filtration, lyophilisation, aliquotation
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)
3.6
Quality Control Testing
3.6.1 Physical / Chemical testing
Clarifying remarks (for public users):
