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BASG - Bundesamt für Sicherheit im Gesundheitswesen

CERTIFICATE NUMBER: 481925-100722458

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: Sandoz GmbH

Site address:

Schaftenau Plant, Biochemiestraße 10, Unterlangkampfen, Langkampfen, Tirol, 6336, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000546 / LOC-100001678

Other

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

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

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-07-07 , 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

1.4 Other products or manufacturing activity

1.4.3 Other: Lagerung von Wirkstoffen für die Herstellung von Arzneimitteln bei Sandoz GmbH - Betriebsstätte / Manufacturing Site Aseptics Drug Product Schaftenau (Aseptics DPS, Lizenznummer: 482451) / Storage of active substances for the manufacture of medicinal products at Sandoz GmbH - Betriebsstätte / Manufacturing Site Aseptics Drug Product Schaftenau (Aseptics DPS, license number: 482451) Lagerung von Analytical- und/oder Master- und/oder Working Cell Banks / storage of analytical cell banks and/or m…, Lagerung von Wirkstoffen für die Herstellung von Arzneimitteln bei Sandoz GmbH - Betriebsstätte / Manufacturing Site Aseptics Drug Product Schaftenau (Aseptics DPS, Lizenznummer: 482451) / Storage of active substances for the manufacture of medicinal products at Sandoz GmbH - Betriebsstätte / Manufacturing Site Aseptics Drug Product Schaftenau (Aseptics DPS, license number: 482451) Lagerung von Analytical- und/oder Master- und/oder Working Cell Banks / storage of analytical cell banks and/or m…(en)

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

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

[900000005407]Etanercept (TNF receptor p75 Fc fusion protein, rDNA)(en)

[900000005408]Rituximab (CD20 Mab, rDNA)(en)

[900000005409]Adalimumab (TNF Mab, rDNA)(en)

Secukinumab(en)

[900000005413]MBG453(en)

[900000005414]CFZ533(en)

[900000005618]SEG101 (Crizanlizumab)(en)

[900000005643]JPB898A1 (NIVOLUMAB)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Etanercept (TNF receptor p75 Fc fusion protein, rDNA)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:Rituximab (CD20 Mab, rDNA)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:Adalimumab (TNF Mab, rDNA)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:Secukinumab

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:MBG453

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:CFZ533

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:SEG101 (Crizanlizumab)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Active Substance:JPB898A1 (NIVOLUMAB)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
Chinese Hamster Ovary Cells (CHO)

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

Clarifying remarks (for public users):

Sandoz GmbH - Betriebsstätte / Manufacturing Site Biotechnology Drug Substance Schaftenau (BT DSS); Probebetrieb betreffend folgender Verfahren gültig bis 06/2024: / Regarding the following inspection cases valid until 06/2024: INS-481925-0077 INS-481925-0092 INS-481925-13063084 INS-481925-100120097 INS-481925-100512520 INS-481925-100207982 INS-481925-100204978 INS-481925-100721922 INS-481925-100378351 INS-481925-100722458

Withdrawal comments in English: The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

Withdrawal comments in National Language: The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

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.