🏻GUIDANCE DOCUMENTS AND INFORMATION?

• 🏻ICH Guidelines : International council on harmonisation guidelines.
• 🏻WHO Guidelines : World health organization guidelines.
• 🏻IPEC Guidelines: The international pharmaceutical excipients  council europe.
• 🏻PIC/S: The pharmaceutical inspection convention and pharmaceutical inspection co-operation scheme.
• 🏻EMA:  Europe medicines agency European Commission: Medicinal products for human and veterinary use.
• 🏻PAHO: Pan Americal health organization.
• 🏻21 CFR Part 210: Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs (General).
• 🏻21 CFR 211: Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; Current good manufacturing practice for finished pharmaceuticals.
• 🏻21 CFR 58: Good laboratory practice for non-clinical laboratory studies.
• 🏻21 CFR 600 : Biological products in general.
• 🏻21 CFR 601: Licensing.
• 🏻21 CFR 610: General biological products standards.
• 🏻21 CFR 606: CGMP for blood and blood components.
• 🏻FDA: Food and drug administration.
• 🏻TGA: Therapeutic goods administraion,Australia
• 🏻CDSCO: Central drugs standard control orgainzation.
• 🏻MHRA: Medicine and heath care products regulatory agency.
• 🏻PMDA: Pharmaceuticals and medical devices agency, Japan.
• 🏻MEDSAFE: New Zealand medicines