CERTIFICATE NUMBER:
DE_NW_04_GMP_2024_0040
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1)
, (2)
Part 1
Issued following an inspection in accordance with
The competent authority of Germany confirms the following:
The manufacturer: BSV Bioscience GmbH
Site address:
Max-Planck-Strasse 12, Baesweiler, North Rhine-Westphalia, 52499
OMS Organisation Id. / OMS Location Id.: ORG-100008284 / LOC-100012519
Has been inspected under the national inspection programme in connection with manufacturing authorisation no.
DE_NW_04_MIA_2024_0024
in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).
Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Sect. 64 para 1 and 3 German Medicinal Product Act.
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2023-11-24
, 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 of GMP for active substances referred to in 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:Sect. 64 para 1 and 3 German Medicinal Product Act.
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.
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(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
1 MANUFACTURING OPERATIONS
1.1 Sterile products
1.1.3 Batch certification
1.4 Other products or manufacturing activity
1.4.1 Manufacture of
1.5 Packaging
1.5.1 Primary Packaging
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
2 IMPORTATION OF MEDICINAL PRODUCTS
2.3 Other importation activities
2.3.1 Site of physical importation
2.3.4 Other: Import of concentrated human urine (e.g. after precipitation and vacuum drying) from China as starting material for the production of active pharmaceutical ingredients(en)
Manufacture of active substance. Names of substances subject to inspection:
[00022220-00001]Human Chorionic Gonadotropin (HCG) Human Menopausal Gonadotropin (HMG) Human Follicle Stimulating Hormone (FSH) Urinary Trypsin Inhibitor (Ulinastatin, UTI) Urokinase from human urine (UK)(en)
[00022220-00002]Streptokinase(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
3.2
Extraction of Active Substance from Natural Sources
3.2.3 Extraction of substance from human source
3.2.6 Purification of extracted substance Human
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
3.6.3 Microbiological testing including sterility testing
3.6.4 Biological Testing
3.3
Manufacturing of Active Substance using Biological Processes
3.3.3 Isolation / Purification
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
3.6.3 Microbiological testing including sterility testing
3.6.4 Biological Testing
Clarifying remarks (for public users):
