Read, Learn, Innovate: Top Blog Posts from August 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from August 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Data provides direct evidence that products are safe and effective – telling the story of drug products, long after they have been manufactured and shipped. As part of its mission to ensure the safety, efficacy and quality of products produced by the pharmaceutical industry, the FDA expects that all data submitted to the agency to obtain market approval is both reliable and accurate.
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.
ISPE’s Advancing Pharmaceutical Quality (APQ) team and the University of St.Gallen Operational Excellence (OPEX) team have partnered to develop a comprehensive program for assessing and improving an organization’s Quality Management Maturity. ISPE is developing the Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework, a program comprised of quality maturity assessments, key performance indicators (KPIs), and continual improvement tools focused on advancing organizational capabilities across the four ICH Q10 Pharmaceutical Quality System (PQS) elements:
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or DtP. However, the implementation of Direct-to-Patient may seem insurmountable in a highly regulated industry where specific regulations or guidance is lacking or vague.
There is a real advantage in opening up and confiding in someone. Being vulnerable can be a superpower, but it does not mean that you should trust everyone with everything. It also does not mean that you should always emotionally charged break downs....