| BMG | Betriebsverordnung für die Herstellung von Wirkstoffen für Arzneimittel (WirkstoffBetr.V) borrador alemán (oct. 1994) |
| CEFIC | Guidelines for Handling and Distribution of Propylene Glycol USP/Ph.Eur., Propylene Oxide/Propylene Glycols Sector Group of CEFIC (1999) |
| CEFIC/EFPIA | GMP para los fabricantes de ingredientes activos (agosto 1996) |
| DEFIC/FECC | European Single Assessment Document for Chemical Distributors (ESAD), publicado por DEFIC y FECC (enero 1999) |
| EU GL | 75/319 (feb. 1999) |
| FDA | Code of Federal Regulation título 21 partes 210 y 211 (sept. 2001) |
| FDA | Code of Federal Regulation título 21 parte 11 Electronic Records, Electronic Signatur, Final rule (marzo 1997) |
| FDA | Guideline on General Principles of Process Validation (feb. 1993) |
| FDA/DHSS | Draft Guidance for Industry on Manufacturing, Processing or Holding APIs (marzo 1998) |
| FECC/VCH/VDC | GMP Guide for APIs, Distributors and Traders (oct. 1998) |
| ICH | Guideline on GMP for APIs (Q7A, julio 2001) |
| ICH | Procedimientos de pruebas y criterios de aceptación para nuevas sustancias de medicamentos y nuevos productos de medicamentos (oct. 1999) |
| ICH | Impurezas en nuevas sustancias para medicamentos (oct. 1999) |
| ICH | Note for Guidance on GMP for API (nov. 2000) |
| IPEC | Audit Guide for Distributors of Bulk Pharmaceutical Excipients (abril 2000, actualmente en revisión) |
| IPEC | GMP Guide for Bulk Pharmaceutical Excipients (dic. 2001) |
| ISO 9001 | Quality Management System, Requirements (dic. 2000) |
| ISPE | Baseline Pharm. Engineer. Guides, Bulk Ph. Chem. (junio 1996) |
| PhRMA | Guide for Production, Packaging, Repackaging or Holding of Medicinal Substances (sept. 1995) |
| PIC/S API | Guide (feb. 1987) |
| PIC/S API | Guide (4. borrador, abril 1997) |
| WHO | GMP for Pharmaceutical Products of the World Health Organization, WHOTechnical Report Series, No. 823, 32nd Report, Ginebra (1992) |
| WHO, FDA, CDC | The Diethylene Glycol Contamination Prevention Workshop (20-21 de febrero de 1997), Washington, D.C. |
| WHO | GMP Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients; WHO Technical Report Series, No. 885 (1999) |
