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The Certificate has been withdrawn, withdrawn date is : 2024-05-14

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Landesamt Fuer Soziale Dienste Schleswig Holstein

CERTIFICATE NUMBER: DE_SH_01_GMP_2023_0027

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 Germany confirms the following:

The manufacturer: UNA-Synth GmbH

Site address:

Leibnizstrasse 12, Kaltenkirchen, Schleswig-Holstein, 24568, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100014770 / LOC-100023297

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 2023-05-25 , it is considered that it complies with:

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.

__________________________________________________________________________________________________________________________

(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

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

[00020604-00003]Racepinephrinhydrochloride(en)

[00020604-00004]Tetrabromopyrocatecholbismut (Bibrocathol)(en)

[00020604-00005]Paclitaxel (powder, crude)(en)

[00020604-00006]g-Strophanthin Octahydrat (Ouabain Octahydrat)(en)

[00020604-00007]Diphenylpyraline Hydrochloride(en)

[00020604-00008]Butetamate dihydrogencitrate(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Racepinephrinhydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt Formation with HCl, discolouration with active charchoal and crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying in vacuum at less than 100 degree C

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Tetrabromopyrocatecholbismut (Bibrocathol)

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Reaction of Tetrabromopyrocatechol with Bismutnitrate, purification w. Aqua pur.

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying in vacuum under stirring followed by milling in stainless steel mill

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Paclitaxel (powder, crude)

3.2 Extraction of Active Substance from Natural Sources

3.2.1  Extraction of substance from plant source
Special Requirements:
7.Other:
Extraction of cytotoxic crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying in vacuum under stirring

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

Active Substance:g-Strophanthin Octahydrat (Ouabain Octahydrat)

3.2 Extraction of Active Substance from Natural Sources

3.2.1  Extraction of substance from plant source

3.2.6  Purification of extracted substance Plant

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying in vacuum at low temperature

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

Active Substance:Diphenylpyraline Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Purification by recrystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Butetamate dihydrogencitrate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Salt formation and purification by washing

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying, milling

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

The laboratory for physical-chemical testing and offices are located in the building with the number 14.

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_SH_01_GMP_2024_0011

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_SH_01_GMP_2024_0011

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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.