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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/184/H/2023

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 Italy confirms the following:

The manufacturer: Biofer S.p.A.

Site address: Via Canina 2, Medolla, MO, 41036, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100007069 / LOC-100011468


Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2022-09-30 , 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.
    		•

    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

    Manufacture of active substance. Names of substances subject to inspection:
    [00000000003632]SULODEXIDE(en)
    [00000000001502]HEPARAN SULFATE(en)
    [00000000001752]IRON PROTEIN ACETYL ASPARTYLATE(en)
    [00000000005836]IRON SUCROSE(en)
    [10000000004796]ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)
    [00000000002151]HYDROCORTISONE HYDROGEN SUCCINATE(en)
    [00000000002639]METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [00000000005899]THIOPENTAL SODIUM AND SODIUM CARBONATE STERILE(en)
    [000000000097]CALCIUM FOLINATE(en)
    [00000000005837]SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE(en)
    [00000000002635]METHYLPREDNISOLONE HYDROGEN SUCCINATE(en)
    [00000000005834]FERRIC SODIUM GLUCONATE(en)
    [00000000002158]HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [00000000005833]FERRIC HYDROXIDE POLYMALTOSE COMPLEX(en)
    [00000000001503]HEPARIN CALCIUM(en)
    [00000000001504]HEPARIN SODIUM(en)
    [00000000005835]IRON DEXTRAN(en)
    [10000000004971]ACTIVE SUBSTANCES (NON STERILE AND/OR NON BIOLOGICAL, NON FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)
    [00000000005838]PROTEOLYTIC ENZYME(en)
    [00000000001751]FERRIC ACETYL TRASFERRIN(en)
    [00000000002593]MESOGLYCAN(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:SULODEXIDE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:HEPARAN SULFATE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.2.5  Modification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophilisation
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:IRON PROTEIN ACETYL ASPARTYLATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    filtration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:IRON SUCROSE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    ultrafiltration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)
    3.5 General Finishing Steps
     
    3.5.4  Other:
    storage

    Active Substance:HYDROCORTISONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:THIOPENTAL SODIUM AND SODIUM CARBONATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CALCIUM FOLINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    ultrafiltration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:FERRIC SODIUM GLUCONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    ultrafiltration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:FERRIC HYDROXIDE POLYMALTOSE COMPLEX
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    ultrafiltration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:HEPARIN CALCIUM
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.2.7  Other:
    salt formation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:HEPARIN SODIUM
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:IRON DEXTRAN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    ultrafiltration
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ACTIVE SUBSTANCES (NON STERILE AND/OR NON BIOLOGICAL, NON FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)
    3.5 General Finishing Steps
     
    3.5.4  Other:
    storage

    Active Substance:PROTEOLYTIC ENZYME
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.2.2  Extraction of substance from animal source
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    lyophilisation, granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:FERRIC ACETYL TRASFERRIN
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.2.5  Modification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:MESOGLYCAN
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    spray drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: FOLIC ACID (confidential), HEPARIN SODIUM CRUDE (confidential), HEPARINOID CRUDE (confidential), HYDROCORTISONE (confidential), METHYLPREDNISOLONE (confidential), PREDNISOLONE (confidential), SULFO-MUCOPOLYSACCHARIDE CRUDE (confidential), THIOPENTAL (confidential)

    Clarifying remarks (for public users):
    According to Italian legislation, sterile active substances are authorized according toart. 40 of Dir. 2001/83/EC and the aseptic processing is performed in accordance with theEU-GMP, including its Annex 1, as laid down in Dir. 2003/94/EC. Imported AS marked asconfidential undergo further processing within the importing site. Hydrocortisone sodiumsuccinate sterile buffered, Methylprednisolone sodium succinate sterile buffered: viasterile filtration (outsourced). On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 36 months from the latest general GMP inspection conducted on 2022/09/30, except for AIFA's re-evaluation of the risk profile.

     

     

    Withdrawal comments in English: withdraw certificate
    Withdrawal comments in National Language: certificato withdraw

    		 
    		 
     
         
     
     
    		 
     
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