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:
| Product | CAS No. | Code | EU ASMF | CEP | US DMF |
|---|---|---|---|---|---|
Acetic Acid 80% w/w GMP | 64-19-7 | 384110 |  | ||
Ammonium chloride GMP | 12125-02-9 | 350314 | RO-CEP-2021-326-Rev 00 | ||
Ammonium molybdate 4 hydrate GMP | 12054-85-2 | 386915 | | ||
Antimony potassium tartrate GMP | 28300-74-5 | 388715 | | ||
Calcium acetate anhydrous GMP | 62-54-4 | 382110 | | ||
Calcium hydrogenphosphate anhydrous GMP | 7757-93-9 | 383410 | | ||
Chromium (III) chloride 6-hydrate GMP | 10125-13-0 | 388115 | | ||
Zinc acetate 2-hydrate GMP | 5970-45-6 | 351244 | R0-CEP 2018-117-Rev 01 | ||
Zinc oxide GMP | 1314-13-2 | 304814 | | |
|
Cobalt (II) chloride 6-hydrate GMP | 7791-13-1 | 386010 | | ||
Copper (II) Chloride 2-hydrate GMP | 10125-13-0 | 387843 | | ||
Copper (II) oxide GMP | 1317-38-0 | 352702 | | ||
Copper II sulphate 5-hydrate GMP | 7758-99-8 | 380214 | | ||
Copper(II) hydroxicarbonate(Malaquita) GMP | 12069-69-1 | 353510 | | |
|
Di-sodium hydrogenphosphate 12-hydrate GMP | 10039-32-4 | 351544 | R0-CEP 2017-233-Rev 02 | ||
EDTA, iron (III) sodium salt 3-hydrate | 18154-32-0 | 333310 | | ||
Iron (III) chloride sol. 10-14% GMP | 7705-08-0 | 382337 | | ||
L(+)-Tartaric acid GMP | 87-69-4 | 381414 | | ||
Magnesium acetate 4-hydrate (parenteral) GMP | 16674-78-5 | 353042 | R0-CEP 2017-280-Rev 00 | ||
Magnesium bromide 6-hydrate GMP | 16674-78-5 | 385610 | | ||
Magnesium fluoride GMP | 16674-78-5 | 355510 | | ||
Magnesium hydroxide GMP | 1309-42-8 | 384514 | | ||
Magnesium L-lactate 2-hydrate GMP | 18917-93-6 | 353414 | | ||
Manganese carbonate precipitated GMP | 598-62-9 | 352310 | | |
|
Manganese (II) chloride 4-hydrate GMP | 13446-34-9 | 354115 | | ||
Nickel sulfate 6-hydrate GMP | 10101-97-0 | 387543 | | ||
Phenol GMP | 108-95-2 | 352610 | | ||
Potassium acetate GMP | 127-08-2 | 387144 | R0-CEP 2018-028-Rev 00 | ||
Potassium bromide GMP | 7758-02-3 | 351814 | | ||
Potassium bromide GMP Crystal. | 7758-02-3 | 371414 | | ||
Potassium chlorate GMP | 3811-04-9 | 384610 | | ||
Potassium iodate GMP | 7758-05-6 | 386811 | | ||
Sodium acetate 3-hydrate GMP | 6131-90-4 | 350944 | R0-CEP 2018-100-Rev 00 | ||
Sodium dihydrogen phosphate anhydrous GMP | 7558-80-7 | 382015 | | ||
Sodium dihydrogenphosphate 1-hydrate GMP | 10049-21-5 | 351015 | | ||
Sodium dihydrogenphosphAte 2-hydrate GMP | 10028-24-7 | 351142 | R0-CEP 2017-177-Rev 02 | ||
Sodium fluoride GMP | 7681-49-4 | 353314 | R1-CEP 2016-103-Rev 00 | ||
Sodium molybdate 2-hydrate GMP | 10102-40-6 | 387614 | | ||
Sodium molybdate 2-hydrate GMP | 10102-40-6 | 387610 | | ||
Sodium selenite GMP | 10102-18-8 | 352514 | | |
|
Succinic acid GMP | 110-15-6 | 382216 | | ||
Tri-sodium citrate 2-hydrate GMP | 6132- 04- 3 | 383215 | |
||
Urea GMP | 57-13-6 | 381114 | |
Para los excipientes, materias primas y reactivos ofrecemos los siguientes dossiers:
- Technical Package
- Dossier básico
| CTD Module 3 Index | Description | ASMF | Technical package | Basic Dossier |
|---|---|---|---|---|
| PRODUCT QUALITY SELF- ASSESMENT | NA | | NA | |
| SUPPLY CHAIN INFORMATION | NA | (only if GMP. Condition: CDA) | NA | |
| 3.2.S.1 | GENERAL INFORMATION | |||
| 3.2.S.1.1 | NOMENCLATURE | | | |
| 3.2.S.1.2 | STRUCTURE | | | |
| 3.2.S.1.3 | GENERAL PROPERTIES | | | |
| 3.2.S.2 | MANUFACTURE | |||
| 3.2.S.2.1 | MANUFACTURER | | | |
| 3.2.S.2.2 | DESCRIPTION OF MANUFACTURING PROCESS | | | flow chart simple |
| 3.2.S.2.3 | CONTROL OF MATERIALS | | NA | NA |
| 3.2.S.2.4 | CONTROL OF CRITICAL STEPS | NA | NA | |
| 3.2.S.2.5 | PROCESS VALIDATION AND/OR EVALUATION | | NA | NA |
| 3.2.S.2.6 | MANUFACTURING PROCESS DEVELOPMENT | | NA | NA |
| 3.2.S.3 | CHARACTERISATION | |||
| 3.2.S.3.1 | ELUCIDATION OF STRUCTURE SND OTHER CHARACTERISTICS | | NA | NA |
| 3.2.S.3.2 | IMPURITIES | | ICH Q3D | TSE/BSE+ allergens+ Halal+ kosher+ etc. |
| 3.2.S.4 | CONTROL OF DRUG SUBSTANCE | |||
| 3.2.S.4.1 | SPECIFICATION | | | |
| 3.2.S.4.2 | ANALYTICAL PROCEDURES | | | List of Methods |
| 3.2.S.4.3 | VALIDATION OF ANALYTICAL PROCEDURES | | NA | NA |
| 3.2.S.4.4 | BATCH ANALYSIS | | | |
| 3.2.S.4.5 | JUSTIFICATION OF SPECIFICATION | | | |
| 3.2.S.5 | REFERENCE STANDARDS OF MATERIALS | | | NA |
| 3.2.S.6 | CONTAINER CLOSURE SYSTEM | | | |
| 3.2.S.7 | STABILITY | |||
| 3.2.S.7.1 | STABILITY SUMMARY AND CONCLUSIONS | | If available: extra cost | Retest date justification |
| 3.2.S.7.2 | POST-APPROVAL STABILITY PROTOCOL AND STABILITY COMMITMENT | | NA | NA |
| 3.2.S.7.3 | STABILITY DATA | | NA | NA |
| only for the restricted part | ||||
Certificados GMP
Tenemos disponibles certificados GMP de AEMPS (Spanish Agency of Medicines and Medical Devices) para todos nuestros APIs.
