Stelios C. Tsinontides, Ph.D., FAIChE Office Director Derek Smith, Ph.D. Acting Associate Director for Regulatory Affairs Office of Pharmaceutical Manufacturing Assessment Office of Pharmaceutical Quality, CDER US Food and Drug Administration PDA Webinar; Monday, June 29, 2020; 10-11:30 AM EST Pre - Approval Inspections during the COVID - 19 Pandemic
17
Embed
Pre-Approval Inspections during the COVID-19 Pandemic · Pre-Approval Inspections during the COVID-19 Pandemic. 2 ... •Ensure timely responses to Agency’s Requests •Treat the
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Stelios C. Tsinontides, Ph.D., FAIChE
Office Director
Derek Smith, Ph.D.
Acting Associate Director for Regulatory Affairs
Office of Pharmaceutical Manufacturing Assessment
Office of Pharmaceutical Quality, CDERUS Food and Drug Administration
PDA Webinar; Monday, June 29, 2020; 10-11:30 AM EST
Pre-Approval Inspections during the COVID-19 Pandemic
2
A quality product of any kind consistently meets the expectations of the user.
Pharmaceutical Quality
www.fda.gov
3
A quality product of any kind consistently meets the expectations of the user.
Pharmaceutical Quality
Drugs are no different.
www.fda.gov
4
Patients expect safe and
effective medicine with every
dose they take.
www.fda.gov
5
Pharmaceutical quality is
assuring every dose is safe and
effective, free of contamination
and defects.
www.fda.gov
6
It is what gives patients
confidence in their next dose
of medicine.
www.fda.gov
7
Across the lifecycle…Across the globe…
Office of Pharmaceutical Quality
7
new drugs
biologics
generics biosimilars
over-the-counter drugs
compounded drugs
Development Premarket Postmarket
DomesticManufacturing
InternationalManufacturing
OPQ
Across product classes…
Policy
Assessment
InspectionSurveillance
Research
8
Office of Pharmaceutical Assessment - OPMA
Mission: Ensure that Quality is built into commercial manufacturing processes and facilities over the product
lifecycle
Office of Pharmaceutical Quality (OPQ) State of Quality Report (Jun 2020):https://www.fda.gov/media/125001/download
9
Team-based Integrated Quality Assessment (IQA)
9
Science- and Risk-Based approach that is patient-focused