Description
The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.
Scope & Applicability
Product Classes
3Also known as MDI; inhalation aerosols intended for local or systemic effect.; MDI products consist of a drug formulation and a container closure system.; MDI drug products quality considerations; MDIs drug products quality considerations; Drug product requiring specific quality controls; Information to be Submitted in Support of an Application for an MDI; Instructions for patient use of the MDI; General Relationship Between QTPP Elements and CQAs for MDIs; MDI products used with a spacer or hol
Also known as DPI; inhalation powders intended for local or systemic effect.; DPI products also consist of a drug formulation and a container closure system.; DPI drug products quality considerations; DPIs drug products quality considerations; Drug product requiring specific quality controls; Information to be Submitted in Support of an Application for a DPI; Labeling requirements for oral and nasal DPIs; DPI product should only be used with the device constituent part provided; DPI performance
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Regulatory Context
Attributes
10A functional role of sodium in food
ensure a confidence level of 95 percent
variation in flow rate for chromatography
PIF through the delivery system
Patient factor affecting drug delivery to lungs
Timeframe after opening protective packaging
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Characterization of DPI device constituent part
Attribute tested during stability studies for MDIs
Chemicals that migrate from the container closure system into the formulation
Identified Hazards
Hazards
2prior knowledge from product development, e.g., on leachables
Potential risk factor for product quality
Related CFR Sections (4)
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR369.21§ 369.21 Drugs; warning and caution statements required by regulations.
ACETAMINOPHEN (N-ACETYL- p -AMINOPHENOL) (See § 310.201(a)(1) of this chapter .)Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-08-19
CGMP/QSR/Medical Devices/Adulterated
Les Encres LLC
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Visgeneer, Inc
- 2025-07-29
CGMP/QSR/Medical Devices/Adulterated
Onkos Surgical, Inc.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
See Also (8)
- CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms (Status: Final)
- Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry (Status: Final)
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (Status: Final)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry (Status: Final)
- Changes to an Approved NDA or ANDA: Guidance for Industry (Status: Final)