Regulations

Below are key regulations, guidances, and compendia pertaining to inhalation product development.   Please contact me for any omissions or errors.

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 Inahalation 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

United States Pharmacopeia (USP) chapter <1151> – Aerosols and Inhalations

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

Metered Dose Inhalers (MDIs)

EMEA – Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurized Metered Dose Inhalation  Products (2002)

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

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)