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3.7 Auto_ID — Value Creation from Big Data and Serialization 191
Walgreens, at the Auto-ID Labs 2012 Big Data Conference [26Auto-ID Big
Data] organized with GS-1 and VICS: the use of the serialized identifier for
prescription refills. For Walgreens today, the majority of web orders for refills
are now placed by consumers using a smartphone barcode scanning application
that ‘reads’ the 2D barcode on the pill-box label which the system
uses to look up the initial order which is to be refilled. As we can see from
this example, Big Data, when tied to individually identified products and/or
transactions, allows a company to link data captured in the physical world or
somewhere on the web, to Enterprise systems processes.
3.7.1.4 Quality by design
The cornerstone of FDA’s quality initiative, Pharmaceutical CGMPs for the
21st Century — A Risked Based Regulatory Approach — takes a Process
Analytic Technology (PAT) and Quality be Design (QbD) holistic approach to
identifying sources of variability (in raw materials, in-process materials and
process factors), to managing variability through process understanding and
risk-mitigating control strategies to improve productivity and product quality
throughout the product lifecycle. Underlying this approach is the notion that
quality should be built-in (i.e., by design).
Harmonization achievements in the Quality area include milestones such
as the conduct of stability studies, defining relevant thresholds for impurities
testing and a more flexible approach to pharmaceutical quality based on
Good Manufacturing Practice (GMP) risk management. Specific areas include
Stability, Analytical Validation, Impurities, Pharmacopoeias, Pharmaceutical
Development and the Development and Manufacture of Drug Substances. As
manufacturing supply chains extend around the world, ASTM in E2500-07
and ICH in Q8 (R2), Q9 and Q10 SDO’s have developed guidelines for GMP
regulations for the industry.
In consortia such the MIT CBI BioMANufacturing Research Program [27
BIOMAN], academia is also working with regulators and industry sponsors
to define advanced GMP, PAT and QbD processes for optimized quality manufacturing
and to develop tools to assess and mitigate risk in biopharmaceutical
production. One approach the group has been discussing with industry
sponsors is to investigate QbD applicability to quality oversight of the global
pharmaceutical supply chain.