Important Documents for the Manufacture and Distribution of OPTIM Glycerine 99.7 USP/EP in Europe
Global Organizations
WHO
| 1. |
Press Release: Starting Materials for Manufacturing of Pharmaceuticals Must Comply with International Standards (WHO/44, 19 May 1998) |
| 2. |
Report: Starting Materials for Pharmaceutical Products: Control and Safe Trade (Geneva, 25-27 May 1998) |
| 3. |
Technical Report Series, No. 885, 1999: Annex 5 – GMP: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients |
European Union Directives
| 1. |
Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (1999 revision in progress) |
| 2. |
Council Directive 78/663/EEC of 25 Jul 1978 laying down specific criteria for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (Glycerol E422) |
| 3. |
Council Directive 89/107/EEC of 21 Dec 1988 on the approximation of laws of the member states concerning food additives authorized for use in foodstuffs intended for human consumption |
| 4. |
Council Directive 93/43/EEC of 14 Jun 1993 on the hygiene of foodstuffs |
| 5. |
Commission Directive 98/86/EC of 11 Nov 1998 laying down specific criteria on food additives other than colours and sweeteners (Glycerol E422) |
Industry Association Guidelines
Dow manufacturers OPTIM™ Glycerine 99.7% USP/EP following IPEC (International Pharmaceutical Excipients Council) Good Manufacturing Guidelines
| 1. |
GMP Audit Guideline for Bulk Pharmaceutical Excipients (11/98) |
| 2. |
GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients (2000) |
| 3. |
IPEC Americas Significant Change Guide for Bulk Pharmaceutical Excipients (2000) |
| 4. |
Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients (current version) |
CEFIC (European Chemical Industry Council)
| 1. |
European Single Assessment Document (ESAD) for Chemical Distributors (Appendix B – Food, Cosmetic and Pharma grade products) |
| 2. |
Guidelines for the handling and distribution of Propylene Glycol USP/EP (1999) |
European Pharmacopoeia
European Pharmacopoeia (Ph. Eur.), current issue
Dow Documents
Cross reference to:
Propylene Glycol USP/EP – Global Good Manufacturing Practice Compliance Manual
NOTE:
This list does not refer to all available documents on regulatory status and guidelines available in the European Union.
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