Fill & Finish of the Future
The technology has barely changed over the last 30 years – surely, it’s time for some long overdue innovation.
Susan Dexter |
When it comes to the final stage of packaging before a product is injected into the patient, it’s understandable that the regulators expect perfection, both in process and the related documentation. This is the last line of defense. Over the past five years, there have been a significant number of quality and compliance issues identified by the FDA, particularly in documentation and quality control. The ‘checks and balances’ that prove sterility are fallible. Indeed, every vial can’t be checked for sterility, so it’s vital to have several layers of accumulated data to be confident that the product is safe. If there are chinks in the armor of quality systems – even if the sterility testing identified no issues – the FDA will not feel confident in the product.
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