Pharmaceutical Dosage Forms: Parenteral Medications, Vol. 3: Regulations, Validation and the Future

Description

Volume 3 provides:

• An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables.
• Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing.
• Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems.
• New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Contents

1. cGMP Regulations of Parenteral Drugs - Terry E. Munson
2. Risk Assessment and Mitigation in Aseptic Processing - James Agalloco and James Akers
3. Validation of Drug Product Manufacturing Processes: NCEs and NBEs - Karoline Bechtold-Peters
4. Visual Inspection - Maria Toler and Sandeep Nema
5. Advances in Parenteral Injection Devices and Aids - Donna L. French and James J. Collins, Jr.
6. SiRNA Targeting Using Injectable Nano-based Delivery Systems - Lan Feng and Russell J. Mumper
7. Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls - Sandeep Nema
8. Techniques to Evaluate Damage and Pain on Injection - Gayle A. Brazeau, Jessica Klapa and Pramod Gupta
9. Parenteral Product Specifications and Stability - Michael Bergren
10. Extractables and Leachables - Edward Smith and Dianne M Paskiet
11. Process Analytical Technology and Rapid Microbial Methods - Geert Verdonk and Tony Cundell
12. Quality Assurance - Michael Gorman
13. Application of Quality by Design in CMC Development - Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh
14. Future of Parenteral Manufacturing - James Agalloco, James Akers, and Russell Madsen

Reviews

". . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production."---Pharmaceutical Technology (Review of 2nd edn – vol 3)

Author Information

Sandeep is Executive Director, Pharmaceutical R&D, Global Biologics in St. Louis where he is responsible for Formulation Development of biotherapeutics with a focus on vaccines and oligonucleotides. In this role he manages projects from discovery support, formulation development, scale-up, and validation through regulatory filings.

Sandeep is a Certified Regulatory Affairs Professional. He is active in AAPS and PDA where he has served as Chairman, Arden House Conference on “Parenteral Products: Integrating Science, Innovation and Patient Needs” (2002); Co-Chair, AAPS/FDA/USP workshop on ‘Future Direction in Aseptic Processing’, (2003); and past Chair of Sterile Product Focus group. He is also an adjunct faculty at University of Tennessee. Sandeep was a Steering Committee Member for the Handbook of Pharmaceutical Excipients.

Sandeep received his PhD in 1992 and since then has been involved with the development of small molecule and protein drugs via Parenteral delivery first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia). He has been lead formulator for four launched products.

John began his career with Burroughs Wellcome Co. in 1989 as a pharmaceutical formulator and worked on a variety of dosage forms including liquid and lyophilized parenterals, topical creams and ointments, and oral liquids. He joined Searle, Inc. in Skokie, IL in 1995 responsible for parenteral product formulation and process development, clinical manufacturing, technology transfer/validation, and the R&D microbiology function. In 2001 he transferred to Chesterfield, MO as Site Leader for the Bioprocess and Formulation Technology organization (Pharmacia, Inc.). Following the Pfizer acquisition in 2003, John led the combined Pharmaceutical and Analytical R&D line for Pfizer Global Biologics and from 2007-2009 the Analytical R&D organization. He currently leads the Business Strategy, Operations, and Clinical Supply Planning function, and serves as Site Director for Pfizer St. Louis Laboratories.

John is active in the American Association of Pharmaceutical Scientists and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to developing three professional training courses and serves regularly as a course instructor for PDA.

John's research interests include parenteral container/closure integrity evaluation and protein stabilization and processing.

Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis. He lives in Wildwood, MO with his wife Sue and their three children.