Science and quality management

Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of new medicines. An excellent illustration of this process of adaptation is recent work by Center for Drug Evaluation and Research (CDER) statisticians who developed innovative and more efficient ways to evaluate a class of products that deliver drugs via the skin. The improved statistical analysis methods greatly enhance the power of drug development studies to provide conclusive results and have led to revised recommendations in CDER guidances. These revisions enhance the ability to develop high-quality generics of these products. “Traditional” Evaluation of Delivery System Adhesion to Skin Transdermal and topical delivery systems (collectively called TDS) are preparations of drugs that are typically dissolved or suspended in a mixture of components, including adhesives, for application to intact skin. These systems may be d

Calibration : Calibration is a process thati demonstrates a particular instrument or device produces results within specified limits, as compared to those produced by a traceable standard over an appropriate range of measurements. Calibration activities must be performed with qualified instruments by an accredited laboratory. Validation:  Validation is a systematic approach to collecting and analysing sufficient data toi give reasonable assurance and documented evidence that a process or an analytical method will, when operated within specified parameters, consistently produce results within predetermined specifications.i Qualification:  The action of proving and documenting that any premises, systems and equipment are properly installed, and/or work correctly and lead to the expected results. Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation. Qualification is a part of validation.

ICH Guidelines International council for harmonization