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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 484295-102771143

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Austria confirms the following:

The manufacturer: Novartis Pharmaceutical Manufacturing GmbH

Site address:

Biochemiestrasse 10, Unterlangkampfen, Langkampfen, 6336, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100045162 / LOC-100074523

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 2023-12-14 , 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. 15 of Directive 2001/20/EC, Art. 111(5) of Directive 2001/83/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

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
           1.1.1.5  Solids and implants
   1.1.3  Batch certification

1.2 Non-sterile products

1.2.2 Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.5  Biotechnology products
           1.3.1.8  Other: Monoklonale Antikörper / monoclonal antibodies, Monoklonale Antikörper / monoclonal antibodies(en)
   1.3.2  Batch Certification (list of product types)
           1.3.2.4  Gene therapy products
           1.3.2.5  Biotechnology products
           1.3.2.8  Other: Monoklonale Antikörper, Monoklonale Antikörper(en)

1.4 Other products or manufacturing activity

1.4.3 Other: Lagerung von Analytical- und/oder Master- und/oder Working Cell Banks / storage of analytical cell banks and/or master cell banks and/or working cell banks; Lagerung von Intermediaten / storage of intermediates, Lagerung von Analytical- und/oder Master- und/oder Working Cell Banks / storage of analytical cell banks and/or master cell banks and/or working cell banks; Lagerung von Intermediaten / storage of intermediates(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms: siehe 1.1.1.5 , siehe 1.1.1.5(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
   2.2.3  Biological medicinal products
           2.2.3.4  Gene therapy products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.2  Importation of intermediate which undergoes further processing
   2.3.4  Other: Import von Arzneimitteln und Prüfpräparaten zur klinischen Prüfung // Import of Human Medicinal Products and Human Investigational Medicinal Products, Import von Arzneimitteln und Prüfpräparaten zur klinischen Prüfung // Import of Human Medicinal Products and Human Investigational Medicinal Products(en)

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)

[900000005659]Secukinumab (AIN457)(en)

[900000005646]MBG453 (Sabatolimab)(en)

[900000005647]CFZ533 (Iscalimab)(en)

[900000005618]SEG101 (Crizanlizumab)(en)

[900000005643]JPB898A1 (NIVOLUMAB)(en)

[900000005661]XXB750(en)

[900000005384]Levothyroxin Sodium(en)

[900000005572]The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)(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

3.6.4  Biological 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

3.6.4  Biological 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

3.6.4  Biological Testing

Active Substance:Secukinumab (AIN457)

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

3.6.4  Biological Testing

Active Substance:MBG453 (Sabatolimab)

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

3.6.4  Biological Testing

Active Substance:CFZ533 (Iscalimab)

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

3.6.4  Biological 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

3.6.4  Biological 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

3.6.4  Biological Testing

Active Substance:XXB750

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

3.6.4  Biological Testing

Active Substance:Levothyroxin Sodium

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Andere / Other: Kommissionierung und Verwiegung von Rohstoffen und Intermediaten und Lagerung von c…

Active Substance:The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

Hersteller Arzneimittel: Novartis Pharmaceutical Manufacturing GmbH; FFür SOM230 Pasireotide Pamoate - Signifor erfolgt die Sterilisation im Endbehältnis bei: / SOM230 Pasireotide Pamoate - Signifor is terminally sterilised at: Synergy Health Däniken AG, Hogenweidstrasse 6, C…; Hersteller klinischer Prüfpräparate: Novartis Pharmaceutical Manufacturing GmbH; Probebetrieb betreffend folgende Verfahren gültig bis / Regarding the following inspection cases valid until 12/2026: INS-484295-101533842 INS-484295-102081921 INS-484295-102771143; Hersteller Wirkstoffe: Novartis Pharmaceutical Manufacturing GmbH; Probebetrieb betreffend folgende Verfahren gültig bis / Regarding the following inspection cases valid until 12/2026: INS-484295-101533842 INS-484295-102081921 INS-484295-102771143;

Withdrawal comments in English: Superseded because new certificate was issued following an inspection

Withdrawal comments in National Language: Superseded because new certificate was issued following an inspection

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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.