This extensive 31-page guideline offers a variety of stability points to evaluate by QA personnel. This guideline is a must if you have any involvement with stability programs in a pharmaceutical environment. Sections include:
· Definitions
· Why test for stability?
· Various guidelines available
· Stress Testing
· Photostability
· Selection of Batches
· Sample collection and ID
· Bracketing
· Matrixing
· Test Attributes
· When to test
· Storage conditions
· Evaluation of data
· Expiration dating
· Protocols
· Sending samples to an outside lab
· Implementing an effective program
· Handling a stability failure
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