Provide adequate controlled facilities for the storage of samples from approximately 30 to 40 lots of clinical drugs peryear under freezer storage refrigeration, controlled room temparature, and elevated temperature (50 C) conditions. Further performance of this project will require in-house, up-to-date analytical and pharmaceutical testing equipment and facilities to adequately evaluate the shelf life of each of the clinical products. The testing requirements and protocols will be determined by NCI in accordance with FDA's Current Good Manufacturing Practices. Testing intervals will normally be 0, 3, 6, 9, 12, 18, 24, 36, 48, and 60 months of storage at one or more of the storage conditions for each of the lots of clinical drugs evaluation. However, fewer or more tests may be assigned by NCI should the drug warrant such schedule modification.
