• Publication Date: 10/01/2012
  • Author(s):
    Dohmeier, Daniel M. Nagao, Lee Norwood, Daniel L. Reckzuegel, Gaby Stults, Cheryl L. M.
  • Organization(s):
    International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
  • Article Type: Technical Articles
  • Subjects: Device Design, Product Development/Formulation
Establishing controls and managing changes in materials are key aspects of elastomer quality. This is the second of a two-part series of articles on elastomers to be published by Inhalation.

Establishing appropriate controls and managing changes in elastomeric materials used in orally inhaled and nasal drug products (OINDPs) are key parts of managing the overall quality of OINDP elastomers. By implementing routine controls throughout the supply chain and a systematic approach to change control, many of the risks associated with minor or major changes can be minimized.

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