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The COVID-19 pandemic has caused unprecedented disruption to the FDA's inspection program
On July 22, 2022, the FDA released a new draft guidance, Questions and Answers for Conducting Remote Regulatory Assessments (RRA Guidance), which describes FDA's plans to continue using these alternative inspection measures in the wake of the COVID-19 pandemic
The FDA formally adopted the RRA as an oversight tool, which allowed the FDA to prioritize targeted on-site inspection methods in a risk-based manner and prepare on-site inspections with records obtained by the RRA
The FDA's RRA guidance, by way of a question-and-answer document, broadly defines remote regulatory assessments to include "examinations of FDA-regulated establishments and their records, conducted entirely remotely, to assess compliance with applicable FDA requirements
According to this guidance, FDA intends to require an RRA when it "helps fulfill FDA's regulatory responsibilities, protect human and animal health .
This guide describes two types of RRAs:
1.
Refusal to participate in a voluntary RRA will not result in FDA taking any enforcement action, but may delay FDA's assessment or cause FDA to consider other actions (eg, inspections) to exercise FDA's oversight responsibilities
2.
According to the guidelines, withdrawing from participation or refusing to provide records may be considered a refusal to participate in a mandatory RRA
FDA can use observations collected during an RRA in conjunction with any observations made in follow-up inspections
This guide also details the potential benefits of having an RRA prior to the exam
What to do next?
The RRA guidance confirms what we have always suspected: Even if FDA resumes normal on-site inspections, the FDA will continue to use its record request authority and remote interactive assessment tools to carry out its regulatory responsibilities
Manufacturers also need to weigh the benefits of participating in a "voluntary RRA" against the burden of responding to multiple rounds of requests for information, and the potential for an RRA to lead to FDA action
