Bibliography

  • European Commission Directive 91/356/EEC : Principles and Guidelines of Good Manufacturing Practice for Medicinal Products
  • The Rules governing Medicinal Products in the European Community : Volume IV : Guide to Good Manufacturing Practice in the Pharmaceutical Industry : Annex 15 : 2000
  • Rules and Guidance for Pharmaceutical Manufacturers and Distributors : 1997 : MCA
  • Note for Guidance on Process Validation : 2000 : EMEA
  • Principals of Qualification and Validation in Pharmaceutical Manufacture : PIC : 1996
  • US Code of Federal Regulations : 21 CFR : Parts 210 / 211
  • Guide to Inspections of Validation of Cleaning Processes : 1993 : US FDA
  • Guide to General Principles of Process Validation : 1987 : US FDA
  • Guide to Inspections of Oral Solid Dosage Forms : 1994 : US FDA
  • Commissioning and Qualification Baseline Guide : 2001 : ISPE