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Pharmaceutical Services Ministry Of Health

CERTIFICATE NUMBER: QILUANTIBIOTICS/2023/001

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

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Cyprus confirms the following:

The manufacturer: Qilu Antibiotics Pharmaceutical Co. Ltd.

Site address:

No. 849 Dongjia Town, Licheng District, Jinan, 250105, China

OMS Organisation Id. / OMS Location Id.: ORG-100033695 / LOC-100052910

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:PART IV, Chapters A and B of the Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law No 70(I) of 2001, as amended..

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-06-29 , it is considered that it complies with:

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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6 Other: Manufacturing of sterile APIs(en)

1.4 Other products or manufacturing activity

1.4.2 Sterilisation of active substance/ excipients/ finished product
1.4.2.1 Filtration

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

The inspection covered only the aseptic manufacturing of: 1. Workshop 330 – Unit 331: sterile Ceftizoxime sodium 2. Workshop 330 – Unit 332: sterile Sulbactam sodium, sterile Cefoperazone sodium and Cefoperazone Sodium and Sulbactam Sodium sterile (mixture) 3. Workshop 300/1000 - Unit 300: sterile Cefoperazone Sodium 4. Workshop 500: sterile Cefoperazone Sodium

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.