• Publication Date: 12/01/2008
  • Organization(s):
    International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Testing, Validation, and Regulatory Compliance
Addressing the complex international regulatory environment governing Chemistry, Manufacturing, and Controls (CMC) for Orally Inhaled and Nasal Drug Products (OINDPs).

A recent survey by IPAC-RS identified over 100 international Chemistry, Manufacturing, and Controls (CMC) regulations and guidelines currently applicable to Orally Inhaled Nasal and Drug Products (OINDPs) and revealed, surprisingly, that no common definition now exists for this group of products. Such a large body of regulations seems disproportionate to the number of products manufactured and sold in this specialized segments of the pharmaceutical industry, even considering the fact that OINDPs contain elements of both pharmaceutical products and medical devices, which makes it reasonable to expect that the regulatory burden should be somewhat higher than for separate drug and device products.

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