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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 482350-103490553

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

Part 1

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

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.

__________________________________________________________________________________________________________________________

(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

1.1.3 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)
           1.3.2.5  Biotechnology products
           1.3.2.6  Human or animal extracted products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Synthetische Peptide, Peptid-Zwischenprodukte und deren Vorstufen / Synthetic peptides, peptide intermediates and their precursors; Chemisch modifizierte Peptid-Proteinkonjugate / chemically modified peptide-protein conjugates(en)

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
           2.2.1.1  Aseptically prepared
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products
           2.2.3.6  Human or animal extracted 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)

Vipivotide tetraxetan(en)

[900000005556]Synthetische Peptide, chemisch modifizierte Peptide bzw. Peptidkonjugate / Synthetic peptides, chemically modified peptides and peptide conjugates(en)

[900000005686]Zadavotide guraxetan (Product code: CA0)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Chemisch modifizierte Peptid-Proteinkonjugate / chemically modified peptide- protein-conjugates

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

Active Substance:peptide-keyhole limpet hemocyanin (KLH)- conjugates and peptide-protein-conjugates

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

Active Substance:Vipivotide tetraxetan

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

Active Substance:Synthetische Peptide, chemisch modifizierte Peptide bzw. Peptidkonjugate / Synthetic peptides, chemically modified peptides and peptide conjugates

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

Active Substance:Zadavotide guraxetan (Product code: CA0)

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):

Lagerung von Wirkstoffen / Storage of Active Pharmaceutical Ingredients Eine Liste der Wirkstoffe, welche hergestellt werden, liegt dem BASG vor / A current list of Active Pharmaceutical Ingredients manufactured is available to the BASG; rstellung und Freigabe folgender Wirkstoffe (synthetische Peptide): / Manufacture and release of the following APIs (Synthetic peptides): DOTA-TOC (Edotreotide, Product code: 540)´, DOTA-TATE (Oxodotreotide, Product code: 984), PSMA-11 (Gozetotide, Product code: AJ0), PSMA-617 (Vipivotide tetraxetan, Product code: CV1), PSMA I&T (Zadavotide guraxetan, Product code: CA0)

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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.