Key regulations, guidances, and compendia relating to inhalation product development. 

General

21 CFR Parts 210 and 211 – Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals

FDA Guidance for Industry – Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products  – Chemistry, Manufacturing, and Controls Documentation (1998)

FDA Guidance for Industry – Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation (2002)

EMEA – Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (2006)

European Pharmacopoeia – Preparations for Inhalation (General Chapter) and 2.9.18 Preparations for Inhalation:  Aerodynamic Assessment of Fine Particles

United States Pharmacopeia (USP) chapter <601> – Aerosols, Nasal Sprays, Metered Dose Inhalers, and Dry Powder Inhalers

FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993)

Metered Dose Inhalers (MDIs)

GUIDELINE ON THE REQUIREMENTS FOR CLINICAL DOCUMENTATION FOR
ORALLY INHALED PRODUCTS (OIP) (2009)

Canadian Standard Z264.1-02 – Spacers and Holding Chambers for Use with Metered-Dose Inhalers (2008)

FDA Guidance – Integration of Dose-Counting Mechanisms into MDI Drug Products (2003)

Nebulizers

United States Pharmacopeia (USP) chapter <1601> – Products for Nebulization

British Standard EN13544-1:2007 – Respiratory Therapy Equipment, Part 1: Nebulizing Systems and Their Components (2007)

PharmEuropa, Vol 18, No. 2  – 2.9.44 Preparations for Nebulization:  Characterization (2006)

ISO 27427 – Anaesthetic and Respiratory Equipment:  Nebulizing Systems and Components (2009)