Chemistry, Manufacturing and Controls
In the area of chemistry, manufacturing and controls, rules and regulations apply. The approval of the original NDA sets the goal. The generic companies have to work toward the same goal. These companies are going to buy the existing brand product, cut it up, and aim at the same target to lock in the same set of specifications.
Microbiology
FDA needs to assure the sterility of the product through the manufacturing process. This step is especially important with injectable products.
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Topic: page 3 of 6 (Lesson: page 12 of 39)