Continuous Product Quality Reviews and FDA quality metrics
Are annual PQRs an old school way of thinking?
A few years ago I was working on a non-pharma, large scale ERP project for a multi-national. During the blueprinting stage of the project the executive team’s user requirements were consistent and at no point during the project changed, they wanted real time, dashboard reporting showing both trends and immediate feedback of what was happening across the different streams of the organisation so they could be both informed and agile in their decision making.
This morning I read a short blog on periodic quality reviews in the pharmaceutical industry which again highlighted to me the disconnect between the old fast dating concept of periodic product quality reviews and the great innovative cutting edge work one of our sister companies is doing around continuous PQRs.
Whilst the international regulatory encouragement is towards quality metrics which heralds the development of useful, product and site specific metrics and the need for companies to evolve their quality metrics program over time. An annual race to complete PQRs prior to a regulatory audit is simply no longer considered effective quality assurance.
This leap in information management aligns broader pharma manufacturers with other industries which have been embracing standardised, real time reporting as good business practices (not just good manufacturing practice) for well over a decade. Usually these visual performance management tools are at line. The Toyota Way, from which many pharma’s have embraced Kaizen and lean manufacturing principles demands access to information in a timely and accurate manner as part of continuously solving root problems to drive organisational learning.
The FDA released a Draft Guidance for industry: Request for Quality Metrics, in July 2015.
The FDA guidance highlights that quality management programs need to mature and progress to ‘leading’ not ‘lagging’ indicators of quality issues. The FDA is turning this requirement internally as well as outward.
‘The FDA is considering the utilization of quality metrics as an input to its risk based inspection models as well as to predict possible drug shortages, determine inspection schedules for a manufacturer, assess post-market change reporting, and re-structure the format of inspection. To that end, the FDA has invited input from industry on which metrics manufacturers use and find effective to assess processes and their risks.
Six years after the TGA adopted internationally harmonised manufacturing standards, PIC/S Guide to Good Manufacturing Practice – 15 January 2009, PE 009-8, regulating periodic quality reviews, is it time for the conversation around ‘periodic’ reviews to shift? Is it time to start looking at tools that allow companies to pro-actively collect and review quality data to improve product quality (and supply) and not just tick a compliance box annually.
Our founder, Trevor Schoerie is one of many people in PharmOut passionate about innovative, cost effective, practical solutions for industry and will be speaking on this continuous product quality reviews and available at the up coming National GMP and Validation forum in Melbourne on the 11th and 12th July.
If you cannot wait that long and would like to know more, i.e. how to set up Microsoft SharePoint to provide this information, get in contact here.