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The Certificate has been withdrawn, withdrawn date is : 2025-01-28

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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPE-CH-1005932

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Mutual Recognition Agreement between the European Union and Switzerland .

The competent authority of Switzerland confirms the following:

The manufacturer: Novartis Pharma AG

Site address:	Lichtstrasse 35, Basel Town, 4056, Switzerland
Additional details on units inspected:	*This GMP-Certificate is valid for the site registered with Swissmedic: Novartis Pharma AG Biotechnology Drug Substance Klybeck (NCA Reference Key 1101807)*

OMS Organisation Id. / OMS Location Id.: ORG-100003908 / LOC-100000364

Other

(Human) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

(Veterinary) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

(Investigational product) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-29 , it is considered that it complies with: The Good Manufacturing Practice requirements referred to in the Agreement of Mutual Recognition between the European Union and Switzerland

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. 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.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

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
   1.3.2  Batch Certification (list of product types)
           1.3.2.5  Biotechnology products

1.6 Quality control testing

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

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

[52]SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
mammalian cells

3.3.3  Isolation / Purification

3.3.4  Modification

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

3.6.4  Biological Testing

4. Other Activities - Active Substances:
Active substances used for the manufacture of investigational medicinal products, Crizanlizumab, Spartalizumab

Withdrawal comments in English: replaced by updated GMP-certificate (new inspection date) ersetzt durch ein aktualisiertes GMP-Zertifikat (neues Inspektionsdatum)

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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.