FDA Pharmaceutical Validation Guidance and ICH: What you must know

The FDA Validation Guidance and ICH: What you should know.
Process validation can be defined generally as a series of activities taking place over the Product Lifecycle. The validation exercise establishes scientific evidence that a process is capable of consistently delivering a quality product. After 24 years, the FDA updated its process validation guidance in 2011. The changes were consistent with trends in place within the pharmaceutical industry. The view has changed from validation being a point in time event to being applicable over the product lifecycle. The life-cycle approach to drug product management is laid down in ICH Q10, Pharmaceutical Quality Systems, ICH Q8 Pharmaceutical Design, and ICH Q9 Quality Risk Management.
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