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The Certificate has been withdrawn, withdrawn date is : 2024-07-05

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Ministry Of Health

CERTIFICATE NUMBER: NBF/5/2023/V

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Italy confirms the following:

The manufacturer: Acs Dobfar S.p.A.

Site address:

Via Rossini 7/9/11, Tribiano, 20067, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100011589 / LOC-100021275

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 2/2023/V in accordance with Art. 88 of Regulation (EU) 2019/6.

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/60.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2018-07-27 , 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

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.6  Other: powders in bulk(en)
                  Special Requirements:
                   1  B-lactam Antibiotics

Manufacture of active substance. Names of substances subject to inspection:

[13956]AMOXCILLIN TRIHYDRATE STERILE(en)

[11326]AMPICILLIN TRIHYDRATE STERILE(en)

[11330]CLOXACILLIN BENZATHINE STERILE(en)

[15416]NAFCILLIN(en)

CLOXACILLIN SODIUM STERILE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:AMOXCILLIN TRIHYDRATE 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

3.5.1  Physical processing steps:
drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

Active Substance:AMPICILLIN TRIHYDRATE 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

3.5.1  Physical processing steps:
drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

Active Substance:CLOXACILLIN BENZATHINE 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

3.5.1  Physical processing steps:
drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

Active Substance:NAFCILLIN

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

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

3.5.1  Physical processing steps:
drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

Active Substance:CLOXACILLIN 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

3.5.1  Physical processing steps:
drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

Withdrawal comments in English: Gmp certificate withdrawn due to further inspection against the site generating an updated entry

Withdrawal comments in National Language: Certificato GMP ritarato a seguito di una ispezione del sito che ha generato un nuovo inserimento

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