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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 480019-103849161

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
Art. 63 of Regulation (EU) 536/2014 as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Austria confirms the following:

The manufacturer: Fresenius Kabi Austria GmbH

Site address:

Estermannstrasse 17, Linz, Oberoesterreich, 4020

OMS Organisation Id. / OMS Location Id.: ORG-100000614 / LOC-100009118

Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Veterinary) NIP-A88-R2019/6/EU

(Investigational product) NIP-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-07-11 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

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/EC, Art. 15 of Directive 2001/20/EC and Art. 80(5) of Directive 2001/82/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
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.6  Liquids for internal use
           1.2.1.8  Other solid dosage forms: Laktulose kristallin / Lactulose crystalline, Laktulose kristallin / Lactulose crystalline(en)
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms: Laktulose kristallin / Lactulose crystalline, Laktulose kristallin / Lactulose crystalline(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

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

[900000005310]Lactulose (equivalent Lactulose liquid Ph.Eur., Lactulose concentrate USP)(en)

[900000005311]Hydroxyethyl starch (equivalent HES 70000, HES 130/0.4, HES 200/0.5, HES 450/0.7)(en)

HETASTARCH(en)

PENTASTARCH(en)

[900000005312]Viastarch(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Lactulose (equivalent Lactulose liquid Ph.Eur., Lactulose concentrate USP)

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Kristallisation, Zentrifugation, Deionisation / Crystallisation, centrifugation, deionisation

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Hydroxyethyl starch (equivalent HES 70000, HES 130/0.4, HES 200/0.5, HES 450/0.7)

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Filtration, Aktivkohle-Behandlung / Filtration, charcoal treatment

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknung / Drying

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

Active Substance:HETASTARCH

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Filtration, Aktivkohle-Behandlung / Filtration, charcoal treatment

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknung / Drying

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

Active Substance:PENTASTARCH

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Filtration, Aktivkohle-Behandlung / Filtration, charcoal treatment

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknung / Drying

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

Active Substance:Viastarch

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Filtration, Aktivkohle-Behandlung / Filtration, charcoal treatment

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknung / Drying

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

Clarifying remarks (for public users):

Für folgende Verfahren Probebetrieb bis zum: / Regarding following inspection cases restricted authorisation valid until: 30.06.2027; INS-480019-0063, INS-480019-100813154, INS-480019-103849161

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

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.