FDA updated compliance program guidance por inspections

Guidance, Documents, Resources
1

The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP) surveillance inspections.

DRUG QUALITY ASSURANCE - Drug Manufacturing Inspection

Quality risk management program:

  • Documented and implemented to ensure hazards (e.g., cross-contamination, adulteration, hazardous impurities such as nitrosamines, nitrosating agents, nitrites, nitrates, and azides) are identified, evaluated, addressed, communicated (to the establishment’s management and FDA), and continuously reviewed as needed throughout a product’s lifecycle
  • Hazardous impurity risk is assessed and control strategies are implemented to mitigate the risk (e.g., actions to address sources of variability, release testing, reduction or elimination of impurities, cleaning validation); control strategies are reviewed following changes and throughout a product’s lifecycle

7356.002_DrugMfgInspections.pdf (535.2 KB)

Conformance to Application - New Drug Application

Verify that the establishment has implemented a risk management system that ensures hazards (e.g., cross-contamination; adulteration; hazardous impurities such as nitrosamines, nitrosating agents, nitrites, nitrates, and azides) are identified, evaluated, addressed, communicated to the establishment’s management and FDA, and continuously reviewed as needed throughout a product’s lifecycle. Consultation with the IQA team regarding potential hazards or hazardous risk may be useful before the inspection. If impurity risks are identified, consult the IQA team as appropriate, and include coverage of one or more of the following, as needed:

  • Verify that the establishment has conducted a risk assessment for hazardous impurities and has implemented strategies and a corresponding risk management system (e.g., actions to address sources of variability, release testing, reduction or elimination of impurities, cleaning validation) to control and mitigate the risk. Ensure that this includes impurity risks identified in the application.
  • Verify that unacceptable levels of hazardous impurities are documented and risks are mitigated. * Verify that the establishment has a control strategy for operations identified as at risk of forming hazardous impurities.
  • Confirm that acceptable specification limits have been established for hazardous impurities if identified in components, the finished product, or as a degradant throughout the product’s lifecycle.
  • Determine whether changes that may impact the type or level of impurities are appropriately evaluated within the establishment’s change management system throughout the product’s lifecycle.

48754314_PAI_0.pdf (699.8 KB)

3 Likes
2

Bringing to all our community members attention FDA’s recent update on the Compliance Program Manual: Drug Manufacturing Inspection

Drug Manufacturing Inspections
REVISION: Revised to add elements of International Council for Harmonisation (ICH) guidances for industry Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; control of nitrosamine impurities; and alternative tools for evaluating facilities

Quality risk management program:

  • Documented and implemented to ensure hazards (e.g., cross-contamination,
    adulteration, hazardous impurities such as nitrosamines, nitrosating agents, nitrites,
    nitrates, and azides) are identified, evaluated, addressed, communicated (to the
    establishment’s management and FDA), and continuously reviewed as needed
    throughout a product’s lifecycle
  • Hazardous impurity risk is assessed and control strategies are implemented to
    mitigate the risk (e.g., actions to address sources of variability, release testing,
    reduction or elimination of impurities, cleaning validation); control strategies are
    reviewed following changes and throughout a product’s lifecycle

Compliance Program Manual: Drug Manufacturing Inspections (683.9 KB)

@trust_user_a @trust_user_b @trust_user_c

6 Likes