1. Ensuring
Quality Standards in Generic Drugs

2. 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

3. Customer Focus

4. Compliance Focus

5. Compliance Focus

6. 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?

7. 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!!!

8. 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

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

10. 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

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

12. 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

13. 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

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

15. Thank You