Saeed Qureshi
PharmacoMechanics, Canada
Title: The scientific basis of defining quality pharmaceutical products and their assessment
Biography
Biography: Saeed Qureshi
Abstract
It is important to note that patients and consumers need drugs or medicines but buy products such as tablet/capsule. In this respect, one must first clearly differentiate between the two – drugs/medicines from products. The capability of releasing or delivery of the drugs from the products as expected then becomes a quality attribute of the products from a patient’s perspective. A formal or regulatory recognition of this critical quality attribute (CQA) is lacking at present, at least in a measurable terms which causes significant hurdles in developing and manufacturing of the pharmaceutical products. This presentation will explain scientific rationale for defining the CQA for pharmaceutical products so that the development process for such products becomes effective, objective and efficient. Unlike the current practices and requirements, which lack scientific basis, the approach or technique for the assessment of quality, thus CQA, must be product independent for an unbiased assessment. Such a product independent evaluation approach is not only a scientific requirement but will hugely simplify product evaluations thus their development and manufacturing. Considering solid oral dosage forms (tablet/capsule) as an example, a new and simple approach based on a universal drug dissolution test will be presented for monitoring CQA. Scientific validity, simplicity and superiority of such an approach in comparison with the current practices will be highlighted.