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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 482464-102410732

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

Part 1

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

The competent authority of Austria confirms the following:

The manufacturer: Pfizer Manufacturing Austria GmbH

Site address:

Uferstrasse 15, Orth An Der Donau, Niederoesterreich, 2304, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100015723 / LOC-100024457

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 482464 in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-09-14 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

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

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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. 80(5) of Directive 2001/82/EC and Art. 111(5) of Directive 2001/83/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
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.3 Biological medicinal products (list of product types)

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

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Zellbanken / cellbanks pDNA Starting Material/ pDNA starting material(en)

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

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

[900000005432]FSME-Virus, inactivated(en)

[900000005433]Neisseria meningitidis (Extract), Neis Vac C(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:FSME-Virus, inactivated

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
aviäre Zellen (Hühner Embryonen)/ avian cells (chicken embryo)

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
ad 4. Inaktivierung/ Inactivation

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

3.6.3  Microbiological testing including sterility testing

3.6.4  Biological Testing

Active Substance:Neisseria meningitidis (Extract), Neis Vac C

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
ad 1. Neisseria meningitidis; ad 4. Konjugation/ Conjugation

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

Pfizer Manufacturing Austria GmbH; Betreffend Herstellung eingeschränkt auf FSME und NeisVac-C Impfstoffe sowie pDNA starting materials in den Gebäuden 05 und 21 / Regarding manufacturing restricted to TBE and NeisVac-C vaccines and pDNA starting materials in buildings 05 and 21; Betreffend Verfahren INS-482464-101551683, INS-482464-101555362 und INS-482464-102138416 Probebetrieb bis: / regarding inspection case INS-482464-101551683, INS-482464-101555362 and INS-482464-102138416 valid until: 31.12.2024

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.