| The FDA Guidance for Industry, Container Closure Systems
for Packaging Human Drugs and Biologics, addresses the review
and evaluation of packaging requirements. According to this
document, each new drug application (NDA) or abbreviated new
drug application (ANDA) should contain enough information to
demonstrate that a proposed container closure system and its
components are suitable for its intended use.
The type and extent of information required will depend on
the dosage form and route of administration. Qualification and
quality review is applied to packaging materials and to the actual
dosage form. Packaging suitability is based on four attributes:
protection, safety, compatibility and performance (function and/
or drug delivery). For injectable dosage forms, the document
outlines the tests required to show that interaction is not a
problem.
Associated components, such as those used only at the
time a dosage is administered, self-adhesive labels and secondary
packaging materials are also included in the review process.
Inhalation and injection drug products have to meet the highest
requirements. There are product-specific draft guidelines for
metered dose inhalers (MDI), dry powder inhalers (DPI), nasal
sprays and inhalation solutions, suspensions and spray drug
products. The identity and concentration of leachables in
inhalation and nasal drug products must be monitored
throughout the dosage form’s shelf life since the product
consists of the dosage form and container closure system. |
