Ensuring Quality Standards in Generic Drugs

QUALITY The father of Quality W.E. Deming and other guru’s like Philip Crosby, Kaoru Ishikawa, Joseph Juran since the early 40’s gave us an excellent philosophy of Quality that rests on 4 strong pillars. 1 Customer 2 Continuous improvement 3 Design 4 Employee engagement

Customer Focus

Compliance Focus

Compliance Focus

The requirements of compliance kept changing Area, Hygiene 80's Cross contamination, Equipment 90's Validation, calibration & training, etc Late 90s early 2000 Data integrity & Quality risk management 2010 onwards Vendor quality management? NEXT?

Continuous improvement Plan, Do, Review, Correct, Learn, Apply Do, Review, Correct Burdened the Doer with more and more documentation Made by Checked by Approved by Authorized by Document cell We taught the How and What , Stopped learning the WHY!!!

Design Result: High Risk At Product Design & Development When document, protocols & procedures are being prepared Products launched with limited development Limited vendor evaluation Documents-cut, copy & paste Result: High Risk

Employee Engagement Deep interaction and involvement of all concerned Training is the least priority 75% to middle and senior level except induction

How do we rebuild the pillars? Bring back focus on customer Have only one standard Have a robust feedback process Incentivise companies to upgrade Slowly raise the standard of Schedule M to meet Indian and Global Customer needs

Continual Improvement Use self assessment check list effectively Give most importance to internal audits and self-inspection findings Listen to the shop-floor

Design-Quality at Source Invest maximum time and resources in design of documents , systems , products Make use of initiatives in place Control on new licenses Need for stability for evaluation prior to licenses BE for new products A fast expanding PMPV programme Uniform compliance standard across the country

Employee Empowerment Use Government initiative like LSSSDC to evaluate, and for training of operators & staff Government / Colleges should build online tools for continuous training programs Encourage college professors to do industrial training at site All India movement to bring back pride in the Pharmacy profession and make it an aspirational career of choice

Total Quality Management has become Total “Management” of Quality Reduce Managing and focus on Total Quality

Thank You