Richtlinien für "Extractables & Leachables"-Studien an Arzneimittelverpackungen

Richtlinien für „Extractables & Leachables“-Studien an Arzneimittelverpackungen

EU Pharmacopeia Chapter 3, incl. Supplement 5.1, 5.2 & 5.3

USP e.g. <381> for elastomers, <661> for polymer characterisation

>FDA Guidance for Industry: Container Closure Systems for Packing Human Drugs and Biologics

>FDA Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products

>FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products

>EMEA CPMP/QWP/4359/03, Guideline on Immediate Packing Materials

>EMEA CPMP/QWP/2845/00, Note for Guidance for Metered Dose Inhalation Products Packing Materials

>EMEA CPMP/QWP/158/96, Note for Guidance on Dry Powder Inhaler