Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
This guidance describes the processes and practices applicable to FDA's Bioresearch Monitoring (BIMO) inspections of sites and facilities involved in FDA-regulated research. It covers inspection procedures, communication practices, and records requirements for both domestic and international inspections to assess compliance with FDA regulations and ensure data integrity and subject protection.
This is a draft guidance. Not for implementation.
Recommended Actions
- Review and understand FDA’s BIMO compliance programs applicable to your establishment
- Prepare electronic information systems to provide appropriate FDA access during inspections
- Ensure availability of knowledgeable staff and relevant records during announced inspections
- Establish process for timely response to Form FDA 483 observations (within 15 business days)
- Implement proper documentation practices for corrective and preventive actions
- Maintain contact information for FDA OBIMO division and center points of contact
- Develop procedures for managing both announced and unannounced inspections
- Train staff on inspection procedures and communication practices with FDA personnel
- Establish process for translating documents if conducting studies internationally
- Review and maintain compliance with applicable FDA regulations and statutory requirements
Key Considerations
Non-clinical testing
- Inspections conducted to determine compliance with Good Laboratory Practice (GLP) requirements
- Inspections of nonclinical laboratories conducting Animal Rule-specific studies
- EPA data audit inspections may be conducted
Software
- Establishments using electronic information systems must provide access to FDA personnel
- FDA can view electronic records via read-only access
- Establishments should be prepared to provide electronic copies or paper copies of requested records
Safety
- Program designed to assess protection of rights, safety and welfare of human trial participants and animal subjects
- Inspections conducted to evaluate potential noncompliance or safety issues raised in complaints
Other considerations
- Pre-announcement practices depend on inspection type and are explained in compliance programs
- Inspection duration varies based on operation complexity, staff availability, observations nature
- Written responses to Form FDA 483 observations encouraged within 15 business days
- International inspections follow same processes as domestic ones with few exceptions
- FDA collaborates with international regulatory partners for joint inspections
Relevant Guidances
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
- Clinical Investigator Disqualification Procedures and Administrative Actions
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
Related references and norms
- 21 CFR 10.115: Good Guidance Practices
- 21 CFR 310.305: Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications
- 21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences
- 21 CFR 329.100: Reporting Requirements for Over-the-Counter Human Drug Products
- 21 CFR 600.80: Postmarketing Reporting of Adverse Experiences
- 21 CFR 803: Medical Device Reporting
- 21 CFR 806: Medical Devices; Reports of Corrections and Removals
Original guidance
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations
- HTML / PDF
- Issue date: 2024-06-05
- Last changed date: 2024-10-01
- Status: DRAFT
- Official FDA topics: International, Biopharmaceutics, Investigation & Enforcement, Animal & Veterinary, IVDs (In Vitro Diagnostic Devices), Bioequivalence, HUD/HDE, Generic Drugs, Radiation-Emitting Products, Clinical Trials, Inspection, Dietary Supplements, Investigational New Animal Drug (INAD), Drugs, Compliance, Premarket, Biologics, Investigational Device Exemption (IDE), Tobacco, Biosimilars, Medical Devices, Food & Beverages, Vaccines, Investigational New Drug Application (INDA), Postmarket, Premarket Approval (PMA), New Animal Drug Application (NADA), Food & Color Additives, Administrative / Procedural
- ReguVirta summary file ID: 81db3d49639ed8bf9e5a67c43f447fe0
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