Recently USP revised General Chapter <1058> [Analytical Instrument Qualification (AIQ) – 1, 2].  Generally it is recognized that instruments described in the pharmacopeias (e.g. USP) are suitable and qualified for their intended purpose so laboratories/industry may use these with confidence as per recommended specifications. In addition, instrument manufacturers provide such instruments meeting or exceeding the recommended pharmacopeial specifications. However, with the revised Chapter <1058> this situation has changed. Continue reading →

Quality has to be defined and measured independently. At present, as definition of the quality of a (pharmaceutical) product, such as tablet/capsule, is not available thus it cannot be measured and/or established (link).

Consider attending the upcoming seminar to learn how quality of a pharmaceutical product can easily be defined and then how it can be measured efficiently and scientifically (link).

Necessary knowledge of physiology, pharmacokinetics, pharmaceutics or modelling/simulation can be acquired or learned with an amazing simplicity. In addition, scientifically valid dissolution results can be obtained with ease which can easily be transferred to plasma drug levels, without involving in vitro-in vivo correlation (IVIVC) step.

Focusing on defining quality and then establishing it by measuring its parameter which will lead to simple, efficient and cost effective product development and manufacturing practices, with significantly reduce regulatory burden.

Recently USP revised the above mentioned chapter (https://tinyurl.com/y9wdfl58) to clarify AIQ terminologies including the definition of Design Qualification [DQ]. There is nothing new in the description that should not have been clearly understood by both – the users and manufacturers of the apparatuses including their service providers. However, confusion exists in the minds of analysts and manufacturers who consider that testing and re-testing of the fixed parameters are the qualification, calibration and/or performance verification steps. The chapter clearly describes that such fixed parameters never need to be retested or re-established. With regards to drug dissolution apparatuses, the so called mechanical calibration and/or meeting of the specifications as described in the USP dissolution chapters <711> and <724> would fall in the fixed parameters category, therefore, would never require testing or re-testing. Continue reading →