manufacturing biological or biotechnology pharmaceuticals manufacturing veterinary pharmaceuticals manufacturing complementary medicines including herbals and medicinal preparing or liquid dose sterile or non-sterile operations API manufacture finished dose manufacture quality Control warehousing inspection, labelling and packing including repacking Australian and other National Medicines Policy applicable regulatory Therapeutic Goods Act might include: frameworks Therapeutic Regulations Manufacturing Principles Therapeutic Goods Orders Pharmacopeias Code of cGMP other TGA guidelines relevant to product and market legislation relating to environmental manufacturing, Occupational Health & Safety US Food, Drug & Cosmetic Act and associated Codes of Federal Regulations and guidance European Directives and legislation of EU member states applicable to pharmaceutical manufacturing Global harmonization PIC/S background and guidance might include: ICH background and guidance Current Good conformance to site-wide manufacturing quality systems for ensuring Manufacturing Practice that products are consistently produced and controlled according to (cGMP) compliance quality standards includes: cGMP requirements might adherence to specific Quality, Quality Assurance, Quality Control, include: Quality Risk Management procedures
manufacturing biological or biotechnology pharmaceuticals manufacturing veterinary pharmaceuticals manufacturing complementary medicines including herbals and medicinal preparing or liquid dose sterile or non-sterile operations API manufacture finished dose manufacture quality Control warehousing inspection, labelling and packing including repacking Australian and other applicable regulatory frameworks might include: National Medicines Policy Therapeutic Goods Act Therapeutic Regulations Manufacturing Principles Therapeutic Goods Orders Pharmacopeias Code of cGMP other TGA guidelines relevant to product and market legislation relating to environmental manufacturing, Occupational Health & Safety US Food, Drug & Cosmetic Act and associated Codes of Federal Regulations and guidance European Directives and legislation of EU member states applicable to pharmaceutical manufacturing Global harmonization might include: PIC/S background and guidance ICH background and guidance Current Good Manufacturing Practice (cGMP) compliance includes: conformance to site-wide manufacturing quality systems for ensuring that products are consistently produced and controlled according to quality standards cGMP requirements might include: adherence to specific Quality, Quality Assurance, Quality Control, Quality Risk Management procedures
curr22450VIC%20PHARMANFPRINCIPLES.docx