The Pharmaceutical Industry continues to go through an unprecedented rate of change, driven by socio-economic, fiscal and globalization factors. This level of change is here to stay for the foreseeable future. For many of us these are challenging times, with mergers, acquisitions, plant closures...
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Peter Calcott writes:
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 th...
Validation 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 moreWhatever the future for QbD, it has certainly brought logic and clarity about how our products should be developed and manufactured. It has raised the importance of ensuring development and manufacturing departments work together.
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?”
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