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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/111/H/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 Italy confirms the following:

The manufacturer: Acs Dobfar S.p.A.

Site address: Viale Addetta 2a, Tribiano, 20067

OMS Organisation Id. / OMS Location Id.: ORG-100011589 / LOC-100053612


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  2024-03-15 , 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:
    [00000000007968]AVIBACTAM SODIUM STERILE(en)
    [0000000000847]CEFALOTIN SODIUM(en)
    [00000000004186]CEFOTAXIME SODIUM STERILE(en)
    [0000000000914]CEFUROXIME(en)
    [00000000005470]CILASTATIN SODIUM STERILE(en)
    [00000000005458]IMIPENEM MONOHYDRATE STERILE(en)
    [00000000004411]TAZOBACTAM SODIUM STERILE(en)
    [0000000000858]CEFAPIRIN SODIUM STERILE(en)
    [0000000000864]CEFAZOLIN SODIUM STERILE(en)
    [0000000000911]CEFTRIAXONE SODIUM STERILE(en)
    [00000000005441]MEROPENEM TRIHYDRATE STERILE(en)
    [0000000000887]CEFOTAXIME(en)
    [0000000000889]CEFOXITIN(en)
    [00000000005878]CEFTRIAXONE SODIUM(en)
    [0000000000915]CEFUROXIME SODIUM STERILE(en)
    [00000000007767]VABORBACTAM STERILE(en)
    [0000000000868]CEFEPIME HYDROCHLORIDE STERILE(en)
    [00000000006141]CEFOTETAN DISODIUM STERILE(en)
    [0000000000863]CEFAZOLIN ACID(en)
    [00000000005761]CEFEPIME HYDROCHLORIDE(en)
    [0000000000891]CEFOXITIN SODIUM STERILE(en)
    [00000000005438]CEFTAROLINE FOSAMIL STERILE(en)
    [00000000003777]CEFTAZIDIME PENTAHYDRATE STERILE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:AVIBACTAM 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,milling
    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:CEFALOTIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFOTAXIME SODIUM STERILE
    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
    Special Requirements:
    1.B-lactam antibiotics
    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,milling
    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:CEFUROXIME
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CILASTATIN SODIUM 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,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:IMIPENEM MONOHYDRATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: B-lactam antibiotics: Penems, Carbacephems, Monobactams
    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,milling
    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:TAZOBACTAM SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation
    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:
    lyophilisation,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:CEFAPIRIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    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,milling
    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:CEFAZOLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    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:
    lyophilisation,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:CEFTRIAXONE SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    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,milling
    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:MEROPENEM TRIHYDRATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: B-lactam antibiotics: Penems, Carbacephems, Monobactams
    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,milling
    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:CEFOTAXIME
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFOXITIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFTRIAXONE SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFUROXIME SODIUM STERILE
    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
    Special Requirements:
    1.B-lactam antibiotics
    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,milling
    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:VABORBACTAM 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,milling
    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:CEFEPIME HYDROCHLORIDE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    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,milling
    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:CEFOTETAN DISODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation
    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:
    lyophilisation,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:CEFAZOLIN ACID
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFEPIME HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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
    3.6.1  Physical / Chemical testing

    Active Substance:CEFOXITIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    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,milling
    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:CEFTAROLINE FOSAMIL STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    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,milling
    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:CEFTAZIDIME PENTAHYDRATE 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,milling
    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: CEFTRIAXONE SODIUM, ERTAPENEM SODIUM (confidential), IMIPENEM CRUDE (confidential), IMIPENEM MONOHYDRATE STERILE, MEROPENEM CRUDE (confidential), TAZOBACTAM (confidential)

    Clarifying remarks (for public users):
    Imported active substances (AS),marked as confidential undergo further processing at the importing site.Imported sodium ceftriaxone is also released to other AS manuf.site for further processing.Imipenem monohydrate sterile is used for manufacturing medicinal products at the importing site.Importation of AS used for manufacturing medicinal products falls under the responsibility of the QP/QPs listed in the MIA. According to Italian legislation, sterile AS are authorized according to art.40 of Dir.2001/83/EC and the aseptic processing is performed in accordance with the EU-GMP,including Annex 1,as laid down in Dir.2003/94/EC.The validity of the GMP certificate for this manufacturing site is not more than 36 months from the latest general GMP inspection conducted on 2023/11/21), except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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