EudraGMP Homepage      
 
 
MIA | GMP | API REG | WDA | GDP | Sites Help
Tue 10 Nov 2026 16:53:38 BST
GMP Compliance Menu 
Search
GMP Certificates
Non-Compliance Report
  
The Certificate has been withdrawn, withdrawn date is : 2025-07-24


Print Preview
                   
Print Preview (Short version)
                  
Back To Search

 

National Authority Of Medicines And Health Products

CERTIFICATE NUMBER: F053/S1/SA/001/2024

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

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Portugal confirms the following:

The manufacturer: Genibet Biopharmaceuticals S.A.

Site address: Edificio Da Instalacao Piloto Do Ibet Quinta Do Marques, Avenida Da Republica, Oeiras, 2780-157, Portugal

OMS Organisation Id. / OMS Location Id.: ORG-100017561 / LOC-100026331

 DUNS Number: 50-771-0983

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Art.176.º n.º 1 a) of Decree-Law n.º 176/2006, 30 of August.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2022-06-22 , it is considered that it complies with:

  • The principles of GMP for active substances referred to in 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:Art.176.º n.º 1 a) of Decree-Law n.º 176/2006, 30 of August.
    		•

    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. 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

    1  MANUFACTURING OPERATIONS
    1.6  Quality control testing
       1.6.3  Chemical/Physical

    Manufacture of active substance. Names of substances subject to inspection:
    [13463]POLYSACCHARIDES(en)
    [13464]RECOMBINANT PROTEINS(en)
    [13465]PLASMID DNA(en)
    [F053/S1B]VIRUS AND VIRUS LIKE PARTICLES(en)
    [F053/S1C]CELL BANK(en)
    [F053/S1D]VIRAL BANK(en)
    [F053/S1E]IN VITRO TRANSCRIBED RNA(en)
    [F053/S1F]LIVE MICROBIAL PRODUCTS(en)
    [F053/S1A]VACCINES AND OTHER IMMUNOLOGICAL PRODUCTS(en)
    [F053/S1G]SYNTETIC DNA(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:POLYSACCHARIDES
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    bacterial
    3.3.3  Isolation / Purification
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:RECOMBINANT PROTEINS
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    e.g. mammalian/bacterial
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:PLASMID DNA
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    bacterial
    3.3.3  Isolation / Purification
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:VIRUS AND VIRUS LIKE PARTICLES
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.2  Cell Culture:
    e.g. mammalian
    3.3.3  Isolation / Purification
    3.3.5  Other:
    Viral propagation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:CELL BANK
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    e.g. mammlian/bacterial
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:VIRAL BANK
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.2  Cell Culture:
    e.g. mammalian
    3.3.3  Isolation / Purification
    3.3.5  Other:
    Viral propagation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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)

    Active Substance:IN VITRO TRANSCRIBED RNA
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.5  Other:
    Reverse transcription of plasmid DNA
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:LIVE MICROBIAL PRODUCTS
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.5  Modification of extracted substance Human 
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    bacterial
    3.3.3  Isolation / Purification
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:VACCINES AND OTHER IMMUNOLOGICAL PRODUCTS
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.2  Cell Culture:
    mammalian, bacterial
    3.3.3  Isolation / Purification
    3.3.5  Other:
    viral propagation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    3.Live Cells
    7.Other:
    Batch certification
    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

    Active Substance:SYNTETIC DNA
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.5  Other:
    Invitro ligation
    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):
    - Manufacture of API Syntetic DNA added with the inspection of 23rd and 24th May 2024. This site has two buildings: Genibet 1.0 and Genibet 2.0. The facilities were updated with building Genibet 2.0 with the inspection of 23rd and 24th May 2024.

     

     

    Withdrawal comments in English: Replaced by the GMP certificate no. F053/S1/SA/001/2024 with the Ref Key 177908

    		 
    		 
     
         
     
     
    		 
     
    The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

    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.
    [EMA © 2014. EudraGMDP 6.5.4.8 build 2026/01/16 09:45]