Guidances (Drugs) > Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)

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Guidances (Drugs) > Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)

Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)

  

 Guidance for Industry

 

Q8, Q9, & Q10

Questions and Answers

__________

 

Appendix

Q&As from Training Sessions

 

Additional copies are available from:

 

Office of Communications

Division of Drug Information, WO51, Room 2201

Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Ave., Silver Spring, MD 20993-0002

Phone: 301-796-3400; Fax: 301-847-8714

druginfo@fda.hhs.gov

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

 

and/or

 

 Office of Communication, Outreach and

Development, HFM-40

Center for Biologics Evaluation and Research

 Food and Drug Administration

1401 Rockville Pike, Rockville, MD 20852-1448

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 

(Tel) 800-835-4709 or 301-827-1800

 

 

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

 

July 2012

ICH

 

Table of Contents

 

I.    INTRODUCTION

II.  WHAT ARE THE POINTS TO CONSIDER FOR CRITICALITY OF QUALITY ATTRIBUTES AND PROCESS PARAMETERS

A.  Considerations for Establishing CQAs and CPPs

B.  Relationship of Criticality to Control Strategy

III. WHAT ARE THE POINTS TO CONSIDER FOR CONTROL STRATEGY 

A.  Lifecycle of the Control Strategy 

B.  Suitability of Control Strategy at Different Scales 

C.  Specifications and Certificate of Analysis (CoA) for Real-Time Release Testing (RTRT) 

D.  Process for a Batch Release Decision 

IV.  WHAT ARE THE POINTS TO CONSIDER FOR LEVEL OF DOCUMENTATION IN ENHANCED (QBD) REGULATORY SUBMISSIONS 

A.  Risk Management Methodologies 

B.  Design of Experiments 

C.  Manufacturing Process Description 

V.   WHAT ARE THE POINTS TO CONSIDER FOR ROLE OF MODELS IN QUALITY BY DESIGN (QBD) 

A.  Categorization of Models

B.  Developing and Implementing Models 

C.  Model Validation and Model Verification During the Lifecycle 

D.  Documentation of Model-related Information

 VI.  WHAT ARE THE POINTS TO CONSIDER FOR DESIGN SPACE 

A.  Development of Design Space 

B.  Verification and Scale-up of Design Space 

C.  Documentation of Design Space 

D.  Lifecycle Management of a Design Space 

VII.  WHAT ARE THE POINTS TO CONSIDER FOR PROCESS VALIDATION/CONTINUOUS PROCESS VERIFICATION 

A.  General Considerations 

B.  Continuous Process Verification (CPV) 

C.  Pharmaceutical Quality System

 

Guidance for Industry [1]

 

Points to Consider for

Q8, Q9, and Q10