Advisory Committee for Pharmaceutical Science
Draft
PAT Guidance – Update
CDER Guidance for Industry. PAT – A Framework for
Innovative Pharmaceutical Manufacturing and Quality Assurance. Draft
Guidance. August 2003.
Parametric
Tolerance Interval Test for Dose Content Uniformity
1. The Parametric Tolerance Interval Test
(PTIT). Wallace Adams.
2. IPAC-RS. A Parametric Tolerance Interval Test for Improved Control of
Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products.
3. IPAC-RS Summary pages
- Pharmaceutical product quality
assurance through CMC drug development
process. Darlene Rosario.
-
Summary of IPAC-RS proposal for improved control of delivered dose uniformity (DDU) of orally inhaled
and nasal drug products (OINDP). Michael
Golden.
-
Zero tolerance criteria do not assure product quality. John R. Murphy.
Risk-based
CMC Review Proposals
1. FDA Advisory
Committee for Pharmaceutical Science Manufacturing Subcommittee Meeting
· Woodcock,
Janet. Defining quality of a pharmaceutical product. Slides presented
· Hussain, Ajaz.
Quality by design: Next steps to realize opportunities? Slides presented
2. DIA Annual
Conference.
· Chiu,
Yuan-Yuan. FDA GMP initiatives: Impact on CMC reviews/reviewers. Slides
presented
· Sayeed, Vilayat.
Risk-assessment drug product quality attributes. Slides presented
3. FDA Advisory
Committee for Pharmaceutical Science Manufacturing Subcommittee Meeting
· Bensley, Dennis. Changes without prior
approval: An FDA perspective. Slides presented
·
4. FDA/PQRI
Public Workshop – A Drug Quality System for the 21st Century held
5. FDA Advisory
Committee for Pharmaceutical Science transcript from
· Sayeed, Vilayat.
Update on risk-based CMC review. Slides
presented at FDA Advisory Committee for Pharmaceutical Science
· Chiu,
Yuan-Yuan. Risk based CMC review: An update. Slides. presented
at FDA Advisory Committee for Pharmaceutical Science.
Nomenclature
1. Summary of
topic and questions for committee. Moheb Nasr.
2. FDA Advisory
Committee for Pharmaceutical Science transcript from
Research for Generics - Bioequivalence of Topical Products
Summary of topic and questions for the committee.