Sterile Drug Process Inspections FDA Anita R. Michael Pharmaceutical Investigator.
FDA Inspections: Real Experiences & Lessons Learned...FDA Inspections: Real Experiences & Lessons...
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Joan E. Adamo, PhD Study Coordinators Organization for Research and Education (SCORE) 13 Oct 2016 FDA Inspections: Real Experiences & Lessons Learned
Transcript of FDA Inspections: Real Experiences & Lessons Learned...FDA Inspections: Real Experiences & Lessons...
Joan E. Adamo, PhDStudy Coordinators Organization for Research and
Education (SCORE)
13 Oct 2016
FDA Inspections: Real Experiences & Lessons Learned
The Mission of the FDA . . .
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
. . . is two-fold
The Mission of the FDA . . .
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
. . . is two-fold
What is the purpose of an FDA Audit?
Checking practice against procedure(do what you say)
Checking records against procedure(your documentation must prove it)
Checking to see if practice meets GCP / GLP / GMP (QSR) requirements
Pharmaceuticals Medical Devices / IVDs
Chemical / Biological Multiple mechanical and electronic components
Short lifespan Durable equipment / implanted
Toxicology Biocompatibility
Drug interactions Device malfunction
Systemic effects Local effects
Dosing error User error
Drugs and Devices including In Vitro Diagnostics (IVDs)
Pharmaceuticals Medical Devices / IVDs
21 CFR part 312 21 CFR part 812Covers research on all drugs, biologics and vaccines
Only applies to significant risk devices
Investigational New Drug (IND) Application
Investigational DeviceExemption (IDE)
Dosage form / appropriatedosing
Validated software, appropriate configurationCurrent version of device must be equivalent to proposed commercial product
Drug and Device Clinical Trial Considerations
Pharmaceuticals Medical Devices / IVDs
New Drug Application (NDA) for a New Chemical Entity 21 CFR § 314
510(k) Class I and Class II based on equivalence to a predicate device 21 CFR § 807
Long market life Rapid product lifecyclesGood Manufacturing Practices (GMP)
Quality System Regulations(QSRs) and ISO 13485
Biologics License Application(BLA) 21 CFR § 660-680
PreMarket Approval (PMA) for Class III devices 21 CFR § 814
Drug and Device Marketing Requirements
Drug and Device Inspection Highpoints
Pharmaceuticals Medical Devices / IVDsDrug accountability logs Location of unused devices
Expiration dates on products
Expiration / Calibration dates on products
Complaint Handling Implant databasesAdverse Event Logs Medical Device ReportingPatient non-compliance Product failures
Device-specific trainingSterile handling Sterile packaging
FDA conducts several types of inspections to help protect consumers from unsafe products:
• pre-approval inspection after a company submits an application to FDA to market a new product
• “for-cause” inspection to investigate a specific problem that has come to the attention of the FDA
• routine inspection of a regulated facility
When does the FDA inspect?
Observations on an FDA 483 may result from an inspection
Office of Regulatory Support
Dr. Joan E. AdamoDirector, Regulatory Support Services
University of Rochester Clinical and Translational Science Institute
265 Crittenden Blvd, Office 1.216(585) 275-0742
Do we need a quality system?
FDA Inspections
Training
Communicating with the FDA
IND & IDE Submissions
