This draft guidance, entitled "Processes and Practices Applicable to Bioresearch Monitoring Inspections", is going to be of interest to anyone subject to FDA inspections. The types of inspection programs covered are detailed in the guidance, as are the best practices related to inspections (before, during and after).
From the background section:
"From the FDA is authorized at reasonable times to access, inspect, and copy records and other information as described in section 704(a) of the FD&C Act (21 U.S.C. 374(a))…. Specifically, in clarifying the Agency's BIMO inspection authority, section 704(a)(5) includes, among other things, the following:
• the establishments subject to BIMO inspection, e.g., those used by sponsors in connection with developing an application or other submission to FDA for marketing authorization, or those conducting a study related to such an application or submission; and
• the records and other information that may be inspected, e.g., information related to the conduct, results, and analyses of studies, including those involving human trial participants or animal subjects.
It also underscores that those subject to BIMO inspection must provide FDA with access to the information to be inspected (including access to all paper and electronic records and access to electronic information systems used to hold, analyze, process, or transfer that information), and permit FDA to inspect relevant facilities and equipment used in generating that information. At the same time, section 704(a)(5) makes clear that existing safeguards against disclosure of confidential commercial information and trade secrets continue to apply, and that BIMO inspections – like inspections generally – are to be conducted at reasonable times, within reasonable limits, and in a reasonable manner.
#fda #DraftGuidance #BIMO #inspection
https://www.fda.gov/media/179027/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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