Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide: Guidance for Industry | Guideline Explorer

Description

This small entity compliance guide is one of a series of guidance documents prepared in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104- 121). The guidances are intended to explain the actions small entities are required to take to comply with rules for which the Agency prepared a final regulatory flexibility analysis.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Pressurized metered-dose inhalers

Excluded from the sterility rule

Nasal spray drug products

Excluded from the sterility rule

Aqueous-Based Drug Products for Oral Inhalation

Subject of the sterility requirement

Stakeholders

2

Manufacturer

Entity responsible for submitting NDINs

Small Entity

Target audience for the compliance guide

Regulatory Context

Regulatory Activities

2

ANDA

Abbreviated New Drug Application

NDA

New Drug Application

Document Types

1

Supplemental new drug application

Required to establish sterility for existing products

Attributes

1

Sterility

Requirement for devices provided sterile or non-sterile

Technical Details

Processes

1

Sterilization

Required for contaminated equipment and media before disposal

Identified Hazards

Hazards

1

Microbiological contamination

Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water

Related CFR Sections (2)

21CFR211.113§ 211.113 Control of microbiological contamination.
(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.Read full regulation →
21CFR200.51§ 200.51 Aqueous-based drug products for oral inhalation.
(a) All aqueous-based drug products for oral inhalation must be manufactured to be sterile.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Insanitary conditions

15

Failure to validate aseptic processes

7

Failure to perform adequate smoke studies

7

Misbranded drug products

6

Failure to establish and follow appropriate written procedures to prevent microbiological contamination

6

Failure to thoroughly investigate any unexplained discrepancy or failure of a batch

5

Failure to prevent microbiological contamination

5

Failure to thoroughly investigate any unexplained discrepancy

5

Failure to prevent microbiological contamination of drug products purporting to be sterile

5

Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination

4

Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide: Guidance for Industry