On Wednesday, August 19, the FDA issued an immediately effective FAQ guidance detailing its inspections and manufacturing and supply chain changes during the COVID-19 pandemic.
We've summarized a few of the key takeaways below.
View the full guidance document via fda.gov here and contact us today for assistance preparing for inspections or navigating the quickly-changing regulatory environment.
1. The FDA began working to resume prioritized domestic inspections in July.
As explained in an earlier statement, the FDA plans to continue using its COVID-19 Advisory Rating system to determine which regulatory activities could take place in a given geographic region.
Based on its determination, the agency says it's either continuing to conduct “mission-critical” inspections on a case-by-case basis, or, "where possible to do so safely," resume prioritized domestic inspections, "which generally include pre-approval and surveillance inspections."
- Pre-Approval Inspections: The FDA intends to continue using "other tools and approaches" where possible for conducting pre-approval inspections. These include:
- Requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements
- Requesting information from applicants
- Requesting records and other information directly from facilities and other inspected entities
- Resumption of Normal Operations: The agency is using the gating criteria presented in the National Guidelines for Opening Up America Again to determine when it will proceed with its phased resumption of operations.
- Pre-Announcement of Inspections: For the foreseeable future, prioritized domestic inspections will likely be pre-announced to FDA-regulated businesses.
2. "Mission-critical" can mean a few key things when it comes to inspections.
Among the factors the the agency considers when determining whether an inspection (either foreign or domestic) is "mission-critical" are whether a product has a breakthrough therapy designation or regenerative medicine advanced therapy (RMAT) designation, or is used to diagnose, treat or prevent a serious disease without an appropriate therapeutic alternative.
Regulators also noted that both for-cause and pre-approval inspections can be deemed mission-critical.
3. Imported products may be subject to assessment through "other tools and approaches" for ensuring quality.
Some of the alternative quality assessment tools and approaches used to evaluate imported products may include:
- Physical examinations of products arriving at U.S. borders or product sampling and testing before release into commerce
- Reviewing the compliance histories of facilities, using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements
- Requesting records directly from facilities “in advance of or in lieu of” certain drug inspections
4. The agency is using its "PREDICT" screening tool to assign and adjust risk scores for imported products.
Along with record requests, the FDA says it "continues to work with U.S. Customs and Border Protection to target products intended for importation into the United States that violate applicable legal requirements for FDA-regulated products."
The agency plans to continue using its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool "to focus its examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce."
The agency also says it's been using the PREDICT tool to adjust risk scores for imported products as necessary throughout the pandemic.
5. For application assessments, the agency is using "additional tools" to determine the need for an inspection.
During the public health crisis, the FDA is using "additional tools, where available, to determine the need for an inspection and to support the application assessment."
These tools may include:
- Reviewing a firm’s previous compliance history
- Using information sharing from trusted foreign regulatory partners through mutual recognition and confidentiality agreements
- Requesting records “in advance of or in lieu of” facility inspections or voluntarily from facilities and sites
Other important takeaways regarding application assessments:
- The FDA will continue conducting quality assessments of all applications "per normal assessment operations" where "all manufacturing facilities will be evaluated using a risk-based approach consistent with existing guidelines."
- With regard to BIMO inspections, the agency stated it will continue to take a risk-based approach to determining the need for and selection of site for inspection "considering application and site-specific factors."
6. If travel restrictions prevent a pre-approval inspection, it's not an automatic complete response letter.
In situations where travel restrictions prevent FDA from conducting pre-approval inspections, the agency says it will not automatically issue a complete response letter for the application. Decisions related to an application will be based on the "totality of information available" to the agency.
The guidance document offers additional detail into what would likely happen if it's determined that an inspection is needed before approval of the application. See page 5 of the guidance document.
7. The agency has addressed issues related to manufacturing and supply chain changes for already approved products.
Pharmaceutical manufacturers considering adding or changing a facility in an application due to supply chain disruptions caused by COVID-19 should refer to FDA’s established guidance. For drugs and biologics used to treat or prevent COVID-19 and products currently in shortage, submissions should state “Priority Review Requested” and contain supporting information.
Pharmaceutical manufacturers looking to make manufacturing process or facility changes in response to COVID-19 should refer to existing scale up and post-approval change guidance.
Companies should contact the CDER’s Office of Pharmaceutical Quality or the responsible office within the CBER if "circumstances resulting from the COVID-19 pandemic warrant atypical or
flexible submission strategies."
Access the full guidance document from fda.gov here.
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