S.M.A.R.T Pharmaceuticals 2021-2030
Dr Ajaz Hussain, PhD and independent adviser, explains how to make common sense a SMART factory as the political and regulatory push for Industry 4.0 intensifies and take steps to understand options to align natural (i.e., within) and emerging artificial SMARTs - Self-Monitoring,Analysis and Reporting Technology in how we manage systems with Specific, Measurable, Achievable, Relevant, and Timely (or Time-bound) objectives
At the end of 2021, experiencing the surging uncertainty of Omicron as possibly a fifth coronavirus wave threatening a “Dark Winter” in the US and other countries, and anticipating advancing SMART factories making medicines called S.M.A.R.T Pharmaceuticals, this report spirals above the efforts on the ground supercharging the Industry 4.0 revolution to begin a professional journey to 2030.
Like some migratory birds navigate in the darkness using an internal “magnetic compass,” this migration to the next stage of development utilises feelings (experience) to guide progress in uncertainty and complements vision 2020, naturally corrected SMARTly.
To prepare for this journey, let us recall some lessons in process understanding as defined in the “PAT Guidance” (2004) to make sense of anticipated chaos and pandemonium in this decade of the 21st century and know what it will take to be a “good practitioner.” To be objective and evidence-based in our journey, let us select a predicated point of reference, the letter and spirit of the US Food, Drug, and Cosmetic Act of 1938, as amended in 1962.
Acknowledging that nothing is perfect, errors can occur but not repeat as mistakes. When necessary, course-correcting should be based on good and non-theory laden observations. Efforts to improve continually, based on continuing “scientific training and experience” is needed to “fairly and responsibly” deliver “substantial evidence of effectiveness.” Let us begin to explore how to make common sense of SMART as Industry 4.0 advances and take steps to understand options to align our natural and emerging artificial SMART – Self-Monitoring Analysis and Reporting Technology in how we manage systems with Specific, Measurable, Achievable, Relevant, and Timely (or Timebound) objectives.