Paul L. Pluta

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

An ordered process describing calculations activities for compounded dosage forms is described.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

A fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.