Las industrias farmacéuticas y la biofarmacéutica exigen una gran transparencia a lo largo de la cadena de suministro. Por ello, existe una creciente demanda de disponer de documentación completa sobre las materias primas suministradas a este sector.

Nuestro equipo de calidad ofrece soporte reglamentario específico para todos nuestros productos, tanto GMP como no GMP.

Con toda esta documentación, ofrecemos:

  • Registro rápido.
  • Cumplimiento de normas regulatorias internacionales.
  • Apoyo regulatorio para nuestros clientes.
  • Información transparente de la cadena de suministro.

Para los APIs, ofrecemos:

  • CEP (Certificate of Suitability of the European Pharmacopeia).
  • ASMF (Active Substance Master Files).

Todos estos documentos pueden ser proporcionados en formato e-CTD.

CEP & ASMF disponibles:

ProductCAS No.CodeEU ASMFCEPUS DMF
Acetic Acid 80% w/w GMP64-19-7384110
Ammonium chloride GMP12125-02-9350314R0-CEP 2021-326
Ammonium molybdate 4 hydrate GMP12054-85-2

386915
Calcium hydrogenphosphate anhydrous GMP7757-93-9383410
Chromium (III) chloride 6-hydrate GMP USP10125-13-0388115
Cinc acetate 2-hydrate (parenteral) GMP5970-45-6351244R0-CEP 2018-117-Rev 00
Cinc oxide GMP1314-13-2304814
Cobalt (II) chloride 6-hydrate GMP QP7791-13-1386010
Copper (II) oxide GMP1317-38-0352702
Copper II sulphate 5-hydrate GMP7758-99-8380214
Copper(II) hydroxicarbonate(Malaquita) GMP12069-69-1353510
Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP10039-32-4351544R0-CEP 2017-233-Rev 01
L(+)-Tartaric acid GMP87-69-4381414
Magnesium acetate 4-hydrate (parenteral) GMP16674-78-5353042R0-CEP 2017-280-Rev 00
Magnesium bromide 6-hydrate GMP QP16674-78-5385610
Magnesium fluoride GMP QP16674-78-5355510
Magnesium hydroxide GMP1309-42-8384514
Magnesium L-lactate 2-hydrate GMP18917-93-6353414
Manganese carbonate precipitated GMP598-62-9352310
Phenol GMP108-95-2352610
Potassium acetate (parenteral) GMP127-08-2387144R0-CEP 2018-028-Rev 00
Potassium bromide GMP7758-02-3351814
Potassium bromide GMP Crystal.7758-02-3371414
Potassium chlorate GMP3811-04-9384610
Potassium iodate GMP7758-05-6386811
Sodium acetate 3-hydrate (parenteral) GMP6131-90-4350944R0-CEP 2018-100-Rev 00
Sodium dihydrogen phosphate anhydrous GMP USP7558-80-7382015
Sodium dihydrogenphosphate 1-hydrate GMP10049-21-5351015
Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP10028-24-7351142R0-CEP 2017-177-Rev 01
Sodium fluoride GMP PH7681-49-4353314R1-CEP 2016-103-Rev 00
Sodium molybdate 2-hydrate GMP PH10102-40-6387614
Sodium molybdate 2-hydrate GMP QP10102-40-6387610
Sodium selenite GMP PH10102-18-8352514
Succinic acid110-15-6382216
Tri-sodium citrate 2-hydrate GMP6132- 04- 3383243
Urea GMP57-13-6381114

Para los excipientes, materias primas y reactivos ofrecemos los siguientes dossiers:

  • Technical Package
  • Dossier básico
CTD
Module
3 Index		DescripciónASMF
Technical
package
Basic
free of
charge
PRODUCT
QUALITY
SELF-
ASSESMENT		NANA
SUPPLY
CHAIN
INFORMATION		NA
(only if GMP. Condition: CDA)		NA
3.2.S.1GENERAL
INFORMATION
3.2.S.1.1NOMENCLATURE
3.2.S.1.2STRUCTURE
3.2.S.1.3GENERAL
PROPERTIES
3.2.S.2MANUFACTURE
3.2.S.2.1MANUFACTURER
3.2.S.2.2DESCRIPTION
OF
MANUFACTURING
PROCESS		flow chart simple
3.2.S.2.3CONTROL
OF
MATERIALS		NANA
3.2.S.2.4CONTROL
OF
CRITICAL
STEPS		NANA
3.2.S.2.5PROCESS
VALIDATION
AND/OR
EVALUATION		NANA
3.2.S.2.6MANUFACTURING
PROCESS DEVELOPMENT		NANA
3.2.S.3CHARACTERISATION
3.2.S.3.1ELUCIDATION
OF
STRUCTURE
SND OTHER
CHARACTERISTICS		NANA
3.2.S.3.2IMPURITIESICH Q3DTSE/BSE+ allergens+ Halal+ kosher+ etc.
3.2.S.4CONTROL
OF DRUG
SUBSTANCE
3.2.S.4.1SPECIFICATION
3.2.S.4.2ANALYTICAL
PROCEDURES
List of methods
3.2.S.4.3VALIDATION
OF
ANALYTICAL
PROCEDURES		NANA
3.2.S.4.4BATCH
ANALYSIS
3.2.S.4.5JUSTIFICATION
OF
SPECIFICATION
3.2.S.5REFERENCE
STANDARDS OF
MATERIALS		NA
3.2.S.6CONTAINER
CLOSURE
SYSTEM
3.2.S.7STABILITY
3.2.S.7.1STABILITY
SUMMARY AND
CONCLUSIONS		If available: extra costRetest date justification
3.2.S.7.2POST-APPROVAL
STABILITY PROTOCOL
AND STABILITY
COMMITMENT		NANA
3.2.S.7.3STABILITY
DATA		NANA
only for the restricted part

Certificados GMP

Tenemos disponibles certificados GMP de AEMPS (Spanish Agency of Medicines and Medical Devices) para todos nuestros APIs.