In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance. Q. Since FDA published their ...

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 ...

Whether you're making cookies or computers, your product should provide consistent high quality to your customers. The term "quality assurance" describes all the processes and procedures involved in ...

Poly(3-hydroxyalkanoates) (PHA) are biodegradable polyesters produced by various bacteria, including Cupriavidus necator. The composition of PHA depends on the type of microorganism, cultivation ...