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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products

Sample text

PACKAGE A. GENERAL CONSIDERATIONS 4. The potential for adverse effect on the identity, strength, quality, purity, or potency of a product as these factors may relate to the safety or effectiveness of the product when making a change to or in the container closure system is generally dependent on the route of administration of the drug product, performance of the container closure system, and likelihood of interaction between the packaging component and the dosage form. In some cases there may be a substantial potential for adverse effect, regardless of direct product testing for conformance with the approved specification.

A change in or addition or deletion of a desiccant 4. D. MINOR CHANGES (ANNUAL REPORT) The following are examples of changes that are considered to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as these factors may relate to the safety or effectiveness of the product. 1. A change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system under a protocol approved in the application or published in an official compendium 2.

Recommended chemistry, manufacturing, and controls tests to support each level of change 3. Recommended in vitro release tests or in vivo bioequivalence tests to support each level of change 4. Documentation to support the change The effect that scale-up and postapproval changes may have on the stability of the drug product should be evaluated. For general guidance on conducting stability studies, see the FDA Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics.

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