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The Certificate has been withdrawn, withdrawn date is : 2024-01-17

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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/187/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: Takeda Manufacturing Italia S.p.A.

Site address:

Via Della Chimica 5, Cittaducale, 02015, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100005255 / LOC-100001689

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 2023-04-26 , 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:

[0000000000100486]FACTOR IX ELUATE (INTERMEDIATE FOR FACTOR IX BULK)(en)

[0000000000100488]FEIBA ELUATE (INTERMEDIATE FOR FEIBA BULK POWDER)(en)

[0000000000100485]DEAE ELUATE (INTERMEDIATE FOR C1 INHIBITOR)(en)

[0000000000100466]PRECIPITATE G(en)

[0000000000100439]CRYO PASTE(en)

[0000000000100433]FRAZIONE II (INTERMEDIATE FOR INTRAVENOUS IMMUNOGLOBULIN)(en)

[0000000000100484]AMMONIUM SULFATE PRECIPITATE ANTITHROMBIN III (INTERMEDIATE FOR ANTITHROMBIN III NF BULK)(en)

[0000000000100487]FACTOR VII ELUATE (INTERMEDIATE FOR FACTOR VII BULK)(en)

[0000000000100427]HUMAN ALBUMIN BULK(en)

[0000000000100442]FRACTION V(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:FACTOR IX ELUATE (INTERMEDIATE FOR FACTOR IX BULK)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:FEIBA ELUATE (INTERMEDIATE FOR FEIBA BULK POWDER)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:DEAE  ELUATE (INTERMEDIATE FOR C1 INHIBITOR)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:PRECIPITATE G

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:CRYO PASTE

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:FRAZIONE II (INTERMEDIATE FOR INTRAVENOUS IMMUNOGLOBULIN)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:AMMONIUM SULFATE PRECIPITATE ANTITHROMBIN III (INTERMEDIATE FOR ANTITHROMBIN III NF BULK)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:FACTOR VII ELUATE (INTERMEDIATE FOR FACTOR VII BULK)

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:HUMAN ALBUMIN BULK

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:FRACTION V

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Human

3.2.3  Extraction of substance from human 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)

3.6 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: FRACTION V

Clarifying remarks (for public users):

Imported active substances (AS) marked as confidential are used for manufacturing AS and medicinal products within the importing site, contractor and/or sister companies. Importation of AS used for manufacturing medicinal products falls under the responsibility of the QP/QPs listed in the MIA. According to Italian legislation, all the biological active substances and/or active substances deriving from human and animal tissues, organs, fluids are authorized according to art. 40 of Dir. 2001/83/EC. The site imports Human Plasma according to the PMF Certificate n. EMEA/H/PMF/000003/2004. 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 2024/04/26, 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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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.