Improve Pharma Quality Control
Problem in short
Six product recalls per day in the USA alone in 2019. Drug recalls growing at 23.8% (CAGR 12-19). Sales value of recalled drugs in US & EU totals CHF 36bn p.a. Withdrawal rate of drugs due to harmful effects is 6%
Quality control in pharma manufacturing is difficult, slow and costly - total est. personnel cost CHF 135bn as ⅓ of pharma workforce has quality related assignments
Substantial outsourcing to be controlled - large PharmaCos work with 100-200 contract manufacturing organisations (CMO) and outsourced API manufacturing is at 55% > incoming goods control burden is substantial
Batch-to-batch variation is the challenge - rigid «document based» batch releases are reality
COVID-19 related drug supply bottlenecks – sourcing drugs from new sources of supply increases risk for governments & patients
obvioTec® value proposition
obvioTec Solution reduces recalls by 54%
Enables finished product quality control through packaging (MAH*& suppliers)
Enables in-process control during the manufacturing of semi-finished and finished pharmaceutical medicines
Provides data regarding «batch-to-batch variation» and enables specific analytics to support batch release
Provides triage capabilities to reduce time consuming and costly traditional bio lab testing methods
Saves cost: redirection of skilled QC employees to other value adding tasks
Pharmaceutical Industry
Covering activities of Pharmaceutical Corporations
(= *Marketing Authorization Holder or MAH): Pharmaceutical-Manufacturing and -Supply Chain.