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ISO to Contact Lens Manufacturers: Perform Risk-Based Shelf Life Tests

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Contact lens manufacturers should tie risk assessments to the shelf life of their products to ensure they don’t deteriorate during storage and are safe and effective when used, a revised International Organization for Standardization (ISO) standard advises. The standard requires contact lens makers to perform a risk assessment and then a test to determine the shelf life of their products. Under the old standard, shelf life was included in a broader contact lens risk management protocol.
The GMP Letter