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 | Kilolab | API | EU ASMF | CEP | US ASMF |
|---|---|---|---|---|---|---|---|
| L(+)-Tartaric acid GMP | 87-69-4 | 381414 | NO | yes | X | ||
| Calcium hydrogenphosphate anhydrous GMP | 7757-93-9 | 383410 | NO | yes | X | ||
| Cinc acetate 2-hydrate (parenteral) GMP | 5970-45-6 | 351244 | NO | yes | R0-CEP 2018-117-Rev 00 | ||
| Cinc oxide GMP | 1314-13-2 | 304814 | NO | yes | X | X | |
| Copper (II) oxide GMP | 1317-38-0 | 352702 | NO | yes | X | ||
| Copper (II) sulfate anhydrous GMP | 7758-98-7 | 382914 | NO | yes | X | ||
| Copper II sulphate 5-hydrate GMP | 7758-99-8 | 380214 | NO | yes | X | ||
| Copper(II) hydroxicarbonate(Malaquita) GMP | 12069-69-1 | 353510 | NO | yes | X | X | |
| Di-sodium hydrogenphosphate 12-hydrate (parenteral) GMP | 10039-32-4 | 351544 | NO | yes | R0-CEP 2017-233-Rev 00 | ||
| Magnesium acetate 4-hydrate (parenteral) GMP | 16674-78-5 | 353042 | NO | yes | R0-CEP 2017-280-Rev 00 | ||
| Magnesium bromide 6-hydrate GMP QP | 16674-78-5 | 385610 | NO | yes | X | ||
| Magnesium fluoride GMP QP | 16674-78-5 | 385710 | YES | yes | X | ||
| Magnesium hydroxide GMP | 1309-42-8 | 384514 | NO | yes | X | ||
| Magnesium L-lactate 2-hydrate GMP | 18917-93-6 | 353414 | NO | yes | X | ||
| Manganese carbonate precipitated GMP | 598-62-9 | 352310 | NO | yes | X | X | |
| Phenol GMP | 108-95-2 | 352610 | NO | yes | X | ||
| Potassium acetate (parenteral) GMP | 127-08-2 | 387144 | NO | yes | R0-CEP 2018-028-Rev 00 | ||
| Potassium bromide GMP | 7758-02-3 | 351814 | NO | yes | X | ||
| Potassium chlorate GMP | 3811-04-9 | 384610 | NO | yes | X | ||
| Sodium acetate 3-hydrate (parenteral) GMP | 6131-90-4 | 350944 | NO | yes | R0-CEP 2018-100-Rev 00 | ||
| Sodium dihydrogen phosphate anhydrous GMP USP | 7558-80-7 | 382015 | NO | yes | X | ||
| Sodium dihydrogenphosphate 1-hydrate GMP | 10049-21-5 | 351015 | NO | yes | X | ||
| Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP | 10028-24-7 | 351142 | yes | R0-CEP 2017-177-Rev 00 | |||
| Sodium fluoride GMP PH | 7681-49-4 | 353314 | yes | R0-CEP 2016-103-Rev 01 | |||
| Sodium molybdate 2-hydrate GMP | 10102-40-6 | 354010 | yes | X | X | ||
| Sodium selenite GMP PH | 10102-18-8 | 352514 | yes | X | X | X | |
| Succinic acid | 110-15-6 | 382216 | yes | X | X | ||
| Tri-sodium citrate 2-hydrate GMP | 6132- 04- 3 | 383243 | yes | X | X | ||
| Urea GMP | 57-13-6 | 381114 | yes | X | X | X | |
| Calcium acetate anhydrous (parenteral ) GMP | 62-54-4 | 3821 | yes | X | |||
| Chromium (III) chloride 6-hydrate GMP USP | 10060-12-5 | 354315 | yes | X | X | ||
| Cobalt (II) chloride 6-hydrate GMP QP | 7791-13-1 | 3860 | yes | X | X | ||
| Potassium iodate GMP FCC | 7758- 05- 6 | 386811 | yes | X | X | ||
Para los excipientes, materias primas y reactivos ofrecemos los siguientes dossiers:
- Technical Package: precio 500€
- Dossier básico: gratuito
| CTD Module 3 Index | Descripción | ASMF 12.000€ | Technical package 500€ | Basic free of charge |
|---|---|---|---|---|
| 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: 1000€ 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.
También tenemos certificados GMP para nuestras fábricas emitidos por empresas externas de auditoría como Fórum Auditorías y NQA.
