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The Certificate has been invalidated, invalidated date is : 2024-06-04

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Swedish Medical Products Agency

CERTIFICATE NUMBER: SE-HI-GMP-24-047232

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Sweden confirms the following:

The manufacturer: AstraZeneca AB

Site address:	Forskargatan 18, Sodertalje, 151 36, Sweden
Additional details on units inspected:	*Respiratory products and secondary packaging*

OMS Organisation Id. / OMS Location Id.: ORG-100001699 / LOC-100000556

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. SE-HI-MIA-24-047232 in accordance with Art. 61 of Regulation (EU) No 536/2014.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-12-01 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.5  Liquids for external use
           1.2.1.6  Liquids for internal use
           1.2.1.17  Other: multidose powder inhaler(en)
   1.2.2  Batch certification

1.4 Other products or manufacturing activity

1.4.3 Other: See clarifying remarks(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.17  Other non-sterile medicinal products: multidose powder inhaler(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

4. Other Activities - Active Substances:
Physical processing operations (micronisation and conditioning), packaging and quality control testing of active substances to be used for manufacturing of non-sterile human investigational medicinal products in multidose powder inhalers.

Clarifying remarks (for public users):

1.4.3 - Manufacturing covers hormones or substances with hormonal activity. - Manufacturing also includes preparation and spray drying of nonactive substances as porous particles. - Storage of primary and secondary materials is performed at Gärtunavägen, 152 57 Södertälje. 1.5.2 Manufacturing of investigational medicinal products is restricted to open-label packaging only. 1.6 Quality control testing is performed at addresses Forskargatan 18, 151 36 Södertälje and Gärtunavägen, 152 57 Södertälje.

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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.