16. Selection of Final Product Containers

  1. Manmohan Singh and
  2. Indresh K. Srivastava
  1. Luis Baez and
  2. Adrian Distler

Published Online: 6 JUN 2011

DOI: 10.1002/9781118023648.ch16

Development of Vaccines: From Discovery to Clinical Testing

Development of Vaccines: From Discovery to Clinical Testing

How to Cite

Baez, L. and Distler, A. (2011) Selection of Final Product Containers, in Development of Vaccines: From Discovery to Clinical Testing (eds M. Singh and I. K. Srivastava), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118023648.ch16

Editor Information

  1. Novartis Vaccines, Cambridge, Massachusetts, USA

Author Information

  1. Amgen, Thousand Oaks, California, USA

Publication History

  1. Published Online: 6 JUN 2011
  2. Published Print: 18 JUL 2011

ISBN Information

Print ISBN: 9780470256374

Online ISBN: 9781118023648

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Keywords:

  • clinical, manufacturing issues, container selection - regulatory landscape, cGMP compliance;
  • container design and selection - closure system, integrating active pharmaceutical ingredient (API);
  • container closure integrity, and container qualification - identity, strength, quality

Summary

This chapter contains sections titled:

  • Introduction

  • Container Systems

  • Guidance and Recommendations from Industry and Regulatory Agencies

  • Container Design and Selection

  • Critical to Quality Attributes of the Product

  • Prescreening or Developmental Studies

  • Quality Throughout the Process

  • Container System Components, Suppliers, and the Raw Material Network

  • Container Development and Integrity Evaluation

  • References