| BMG | Betriebsverordnung für die Herstellung von Wirkstoffen für Arzneimittel (WirkstoffBetr.V) German draft (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 for Active Ingredients Manufacturers (Aug. 1996) |
| DEFIC/FECC | European Single Assessment Document for Chemical Distributors (ESAD), Published by DEFIC and FECC (Jan. 1999) |
| EU GL | 75/319 (Feb. 1999) |
| FDA | Code of Federal Regulation title 21 part 210 and 211 (Sept. 2001) |
| FDA | Code of Federal Regulation title 21 part 11 Electronic Records, Electronic Signatur, Final rule (March 1997) |
| FDA | Guideline on General Principles of Process Validation (Feb. 1993) |
| FDA/DHSS | Draft Guidance for Industry on Manufacturing, Processing or Holding APIs (March 1998) |
| FECC/VCH/VDC | GMP Guide for APIs, Distributors and Traders (Oct. 1998) |
| ICH | Guideline on GMP for APIs (Q7A, July 2001) |
| ICH | Test procedures and acceptance criteria for new drug substances and new drug products (Oct. 1999) |
| ICH | Impurities in new drug substances (Oct. 1999) |
| ICH | Note for Guidance on GMP for API (Nov. 2000) |
| IPEC | Audit Guide for Distributors of Bulk Pharmaceutical Excipients (April 2000, currently under revision) |
| IPEC | GMP Guide for Bulk Pharmaceutical Excipients (Dec. 2001) |
| ISO 9001 | Quality Management System, Requirements (Dec. 2000) |
| ISPE | Baseline Pharm. Engineer. Guides, Bulk Ph. Chem. (June 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. Draft, Apr. 1997) |
| WHO | GMP for Pharmaceutical Products of the World Health Organization, WHOTechnical Report Series, No. 823, 32nd Report, Geneva (1992) |
| WHO, FDA, CDC | The Diethylene Glycol Contamination Prevention Workshop (Feb. 20-21, 1997), Washington, D.C. |
| WHO | GMP Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients; WHO Technical Report Series, No. 885 (1999) |
