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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 482464-104232451

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. 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

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

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 2024-05-23 , 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. 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
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

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

3.5 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

Clarifying remarks (for public users):

Hersteller Arzneimittel: Pfizer Manufacturing Austria GmbH; Für folgende Verfahren Probebetrieb bis zum: / Regarding following inspection cases valid until: 31.12.2026 INS-482464-103430198 INS-482464-103513352 INS-482464-104087153 Für das Verfahren INS-482464-103485753 Probeb…; Hersteller klinischer Prüfpräparate: Pfizer Manufacturing Austria GmbH; Für folgende Verfahren Probebetrieb bis zum: / Regarding following inspection cases valid until: 31.12.2026 INS-482464-103430198 INS-482464-103513352 INS-482464-104087153 Für das Verfahren INS-482464-103485753 Probeb…; Hersteller Wirkstoffe: Pfizer Manufacturing Austria GmbH; Für folgende Verfahren Probebetrieb bis zum: / Regarding following inspection cases valid until: 31.12.2026 INS-482464-103430198 INS-482464-103513352 INS-482464-104087153 Für das Verfahren INS-482464-103485753 Probeb…;

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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.