Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

Applying DOE and Risk-Assessment Methods Early Eases Process Validation However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...