References
- Development Pharmaceutics and Process Validation, Guideline of the E. G. Committee for Proprietary Medicinal Products, published in “The Rules governing Medicinal Products in the European Community: Volume III, Guidelines” Commission of the European Communities, January 1989
- , Council Directive of 20th May 1975 (75/318/EEC). Official Journal of the European Communities, No t 147 of 9/6/1975
- Guideline on General Principles of Process Validation. United States Food and Drug Administration. May, 1987
- , Rules governing medicinal products in the European Community, Volume II “Notice to Applicants for marketing authorisations for proprietary medicinal products for human use in the member states of the Europe Communities” January 1989
- , Rules governing Medicinal Products in the European Community, Volume IV “Guide to Good Manufacturing Practice for Medicinal Products” January 1989
- Basic Standards of Good Manufacturing Practice for Pharmaceutical Products. EFTA Secretariat, Geneva March, 1983, Convention for the Mutual Recognition of Inspections in respect of the manufacture of pharmaceutical products
- Guide to Good Pharmaceutical Manufacturing Practice. H. M. S. O., London 1983