CERTIFICATE NUMBER:
078/2024/RO
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1)
, (2)
Part 1
Issued following an inspection in accordance with
The competent authority of Romania confirms the following:
The manufacturer: Purolite S.R.L.
Site address:
Aleea Uzinei Nr 11, Victoria, 505700, Romania
Additional details on units inspected:
PUROLITE SRL, complete address: Aleea Uzinei, nr.11, Oraş Victoria, Loc. Victoria, Judet Braşov, cod poștal 505700, România
OMS Organisation Id. / OMS Location Id.: ORG-100019184 / LOC-100027945
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:art. 857(1) of Law no. 95/2006 regarding the reform in the field of health republished, Title XVIII, Medicinal product.
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2023-10-17
, 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:art. 857(1) of Law no. 95/2006 regarding the reform in the field of health republished, Title XVIII, Medicinal product.
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:
[POLISTIREN SULFONAT DE SODIU]SODIUM POLYSTYRENE SULFONATE(en)
[POLISTIREN SULFONAT DE CALCIU]CALCIUM POLYSTYRENE SULFONATE(en)
[COLESTIRAMINA]COLESTYRAMINE(en)
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
3.1
Manufacture of Active Substance by Chemical Synthesis
3.1.3 Salt formation / Purification steps:salt formation, purification, crystallization
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:purification,crystallization
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:salt formation, purification, crystallization
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
Clarifying remarks (for public users):
Withdrawal comments in English: expired / replaced
Withdrawal comments in National Language: expirat / inlocuit
