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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/284/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: Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.

Site address: Via Fossignano 2, Aprilia, 04011, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100001469 / LOC-100005026


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  2023-09-19 , 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:
    [00000000002155]POTASSIUM CLAVULANATE STERILE(en)
    [0000000000370]AMOXICILLIN SODIUM STERILE(en)
    [00000000004401]SULBACTAM SODIUM STERILE(en)
    [00000000001798]FLUCLOXACILLIN SODIUM STERILE(en)
    [00000000003117]PIPERACILLIN SODIUM STERILE(en)
    [0000000000379]AMPICILLIN SODIUM STERILE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:POTASSIUM CLAVULANATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Salt formation, crystallisation
    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:
    Drying
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:AMOXICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Salt formation, crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    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:
    Drying, sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:SULBACTAM SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    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:
    Drying, sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:FLUCLOXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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:
    drying,sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:PIPERACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Salt formation/Salt formation, crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    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:
    Lyophilization/Drying, sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:AMPICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Salt formation, crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    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:
    Drying, sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.3  Microbiological testing including sterility testing
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: FLUCLOXACILLIN SODIUM (confidential), FLUCLOXACILLIN SODIUM STERILE, PIPERACILLIN (confidential), SULBACTAM (confidential), TERT-BUTYL AMINO CLAVULANATE (confidential)

    Clarifying remarks (for public users):
    According to Italian legislation, sterile active substances are authorized according to art. 40 of Dir. 2001/83/EC and the aseptic processing is performed in accordance with the EU-GMP, including its Annex 1, as laid down in Dir. 2003/94/EC. Imported active substances (AS) marked as confidential are used for manufacturing AS and medicinal products within the importing site and/or a contractor. Importation of AS used for manufacturing medicinal products falls under the responsibility of the QP/QPs listed in the MIA. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 24 months from the latest general GMP inspection conducted on 2023/09/19 except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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