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Health And Youth Care Inspectorate

CERTIFICATE NUMBER: NL/API 24/2052818

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 Netherlands confirms the following:

The manufacturer: Prothya Biosolutions Netherlands B.V.

Site address:

Plesmanlaan 125, Amsterdam, 1066 CX, Netherlands

OMS Organisation Id. / OMS Location Id.: ORG-100001120 / LOC-100000350

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Art. 100 of the Medicines Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-06-27 , 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 transposed in the following national legislation:Art. 100 of the Medicines Act.

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:

ALBUMIN(en)

APOTRANSFERRIN(en)

[6657A]HUMAN PROTHROMBIN COMPLEX(en)

FACTOR VIII INHIBITOR BYPASSING FRACTION(en)

HUMAN NORMAL IMMUNOGLOBULIN(en)

HUMAN HEPATITIS B IMMUNOGLOBULIN (IV)(en)

C1 ESTERASE INHIBITOR (HUMAN)(en)

HUMAN TETANUS IMMUNOGLOBULIN(en)

HUMAN VARICELLA IMMUNOGLOBULIN(en)

HUMAN ANTI-D IMMUNOGLOBULIN(en)

FACTOR IX CONCENTRATE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:ALBUMIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:APOTRANSFERRIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN PROTHROMBIN COMPLEX

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:FACTOR VIII INHIBITOR BYPASSING FRACTION

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN NORMAL IMMUNOGLOBULIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN HEPATITIS B IMMUNOGLOBULIN (IV)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:C1 ESTERASE INHIBITOR (HUMAN)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN TETANUS IMMUNOGLOBULIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN VARICELLA IMMUNOGLOBULIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:HUMAN ANTI-D IMMUNOGLOBULIN

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:FACTOR IX CONCENTRATE

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.5 General Finishing Steps

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

4. Other Activities - Active Substances:
API registration # 6657. This certificate replaces GMP certificate NL/ H 22/2031976B with regards to GMP for Active Substance.

Withdrawal comments in English: This certificate is replaced by certificate number NL/API 25/2057982.

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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.