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The Certificate has been withdrawn, withdrawn date is : 2024-02-08

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2023/059

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of BELGIUM confirms the following:

The manufacturer: Janssen Pharmaceutica

Site address:

Turnhoutseweg 30, Beerse, 2340, Belgium

OMS Organisation Id. / OMS Location Id.: ORG-100000625 / LOC-100005958

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 2 IMP in accordance with Art. 61 of Regulation (EU) No 536/2014.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-03-31 , it is considered that it complies with:

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

Part 2

Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.5  Liquids for external use
           1.2.1.6  Liquids for internal use
           1.2.1.8  Other solid dosage forms: powder and granulates(en)
           1.2.1.13  Tablets
           1.2.1.14  Transdermal patches
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.3  Cell therapy products
           1.3.2.5  Biotechnology products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Challenging agents, limited to packaging and batch certification(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms: Powders and granulates(en)
           1.5.1.13  Tablets
           1.5.1.14  Transdermal patches
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   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

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.2  Immunological products
           2.2.3.3  Cell therapy products
           2.2.3.4  Gene therapy products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

   2.3.2  Importation of intermediate which undergoes further processing
   2.3.3  Biological active substance
   2.3.4  Other: Challenging agents(en)

Clarifying remarks (for public users):

1.1.3: Batch certification of sterile products, including radio-labelled products. 1.3.1.2. Limited to thawing, mixing and filling of externally manufactured bulk solutions 1.3.1.5. Limited to formulation and filling 2.3.2: Partially produced biotechnology products, granulates, powders, non-coated tablets.

Withdrawal comments in English: dubbel

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