CERTIFICATE NUMBER:
sukls19816/2024
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1)
, (2)
Part 1
Issued following an inspection in accordance with
The competent authority of Czechia confirms the following:
The manufacturer: Macco Organiques s.r.o.
Site address:
Zahradni 46c/1938, Bruntal 1, 792 01, Czechia
OMS Organisation Id. / OMS Location Id.: ORG-100017613 / LOC-100037059
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:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2024-03-12
, 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:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.
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
Manufacture of active substance. Names of substances subject to inspection:
[2389729861863970]SODIUM GLYCEROPHOSPHATE HYDRATED, CAS: ---(en)
[23897298618639702989]SODIUM (S)-LACTATE, 50% SOLUTION IN WATER, CAS: ---(en)
[2389729861863970298923]SODIUM (S)-LACTATE, 60% SOLUTION IN WATER, CAS: ---(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.3 Salt formation / Purification steps:synthesis, purification, filtration, concentration, separation
3.5
General Finishing Steps
3.5.1 Physical processing steps:drying
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
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.3 Salt formation / Purification steps:synthesis, neutralization, content solution dilution
3.5
General Finishing Steps
3.5.1 Physical processing steps:drying
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
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.3 Salt formation / Purification steps:synthesis, neutralization, content solution dilution
3.5
General Finishing Steps
3.5.1 Physical processing steps:drying
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
