An NSF International Company Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking ...
Read moreValidation has been a GMP requirement for all pharmaceutical companies for around 25 years now but, unfortunately, as an industry we have become focused on the bureaucracy of the validation process itself rather than the added value it can bring through assurance of product quality. Process vali...
Read moreWe are all probably aware of some non-robust processes in the pharmaceutical industry. We also know that our industry rarely operates at a Six Sigma level – a standard many other industries achieve. Why is this? Are we too focused on compliance? Ha...
Read moreWith Warning Letters and other regulatory action hitting an all time high let’s take time to reflect and ask “What can we learn from the mistakes of others?”
In preparation for this article I canvassed the opinion of some learned friends and colleagues within NSF-DBA and, importantly, some sen...
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