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Generalitat De Catalunya

CERTIFICATE NUMBER: NCF-II/2505/001/CAT

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 Spain confirms the following:

The manufacturer: Quality Chemicals S.L.

Site address:

Calle Fornal 35, Poligono Industrial Can Comellas, Esparreguera, 08292

OMS Organisation Id. / OMS Location Id.: ORG-100025665 / LOC-100034895

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

Other

(Human) artículo 108, Real Decreto Legislativo 1/2015, de 24 de julio, artículo 64, Real Decreto Legislativo 1/2015, de 24 de julio, Real Decreto 824/2010, de 25 de junio, artículo 47 de la Directiva 2001/83/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-01-31 , 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.

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:

[3782]MAGNESIUM ACETATE TETRAHYDRATE(en)

[3784]POTASSIUM ACETATE(en)

[3785]SODIUM ACETATE TRIHYDRATE(en)

[3779]ACETIC ACID(en)

[5606]AMMONIUM CHLORIDE(en)

[5608]AMMONIUM MOLYBDATE(en)

[8128]CITRATE SODIUM DIHYDRATE(en)

[6035]COBALT CHLORIDE(en)

[7915]COPPER CARBONATE(en)

[7419]COPPER CHLORIDE DIHYDRATE(en)

[1911]CUPRIC OXIDE(en)

[4509]COPPER SULFATE PENTAHYDRATE(en)

[1174]CHROMIC CHLORIDE HEXAHYDRATE(en)

[11541]SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE(en)

[11266]SODIUM DIHYDROGEN PHOSPHATE MONOHYDRATE(en)

[4842]FERRIC SODIUM ETHYLENEDIAMINETETRAACETATE(en)

[404]PHENOL(en)

[9000]ANHYDROUS BICALCIUM PHOSPHATE(en)

[1446]SODIUM PHOSPHATE DIBASIC DODECAHYDRATE(en)

[2896]MAGNESIUM LACTATE(en)

[3631]MAGNESIUM BROMIDE(en)

[3635]MAGNESIUM FLUORIDE(en)

[3637]MAGNESIUM HYDROXID(en)

[3840]MANGANESE CARBONATE(en)

[12055]MANGANESE CHLORIDE TETRAHYDRATE(en)

[3279]NICKEL SULFATE(en)

[446]POTASSIUM BROMIDE(en)

[456]POTASSIUM CHLORATE(en)

[19083]POTASSIUM IODATE(en)

[11110]ANHYDROUS SODIUM SELENITE(en)

[511]SODIUM DIHYDROGEN PHOSPHATE(en)

[510]SODIUM FLUORIDE(en)

[1558]SODIUM MOLYBDATE(en)

[4072]SUCCINIC ACID(en)

[1835]TARTARIC ACID(en)

[1839]ANTIMONY POTASSIUM TARTRATE(en)

[400]UREA(en)

[1849]ZINC OXIDE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:MAGNESIUM ACETATE TETRAHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:POTASSIUM ACETATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM ACETATE TRIHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ACETIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.4  Other:
Purification by distillation and dilution

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Filtration

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:AMMONIUM CHLORIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:AMMONIUM MOLYBDATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control análisis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CITRATE SODIUM DIHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:COBALT CHLORIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:COPPER CARBONATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:COPPER CHLORIDE DIHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control análisis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CUPRIC OXIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:COPPER SULFATE PENTAHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CHROMIC CHLORIDE HEXAHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE MONOHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:FERRIC SODIUM ETHYLENEDIAMINETETRAACETATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control análisis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:PHENOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification by distillation

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)

3.5.3  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:ANHYDROUS BICALCIUM PHOSPHATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM PHOSPHATE DIBASIC DODECAHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MAGNESIUM LACTATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MAGNESIUM BROMIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MAGNESIUM FLUORIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MAGNESIUM HYDROXID

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MANGANESE CARBONATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:MANGANESE CHLORIDE TETRAHYDRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:NICKEL SULFATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:POTASSIUM BROMIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:POTASSIUM CHLORATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:POTASSIUM IODATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ANHYDROUS SODIUM SELENITE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM FLUORIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM MOLYBDATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SUCCINIC ACID

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:TARTARIC ACID

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ANTIMONY POTASSIUM TARTRATE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:UREA

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ZINC OXIDE

3.5 General Finishing Steps

3.5.4  Other:
Third party quality control analysis

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

Following a risk-based review of GMP compliance information conducted on 17/02/2025, the validity period of this certificate is extended to 31/07/2025.

Withdrawal comments in English: The GMP compliance certificate has expired.

Withdrawal comments in National Language: El certificado de cumplimiento de NCF ha caducado.

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.