1. GMP -Regulatory Perspective Sukanti Borkar Abbott India Ltd.

2. Content
Quality Culture today
Challenges for Quality
Future of Quality

3. Quality Culture today
Regulatory compliance is becoming increasingly complex and the power and reach of key regulators is ever widening….
In current scenario, there is a shift in regulator approach, where agencies representatives were more practical and concerned about the product quality throughout the product lifecycle but now it is more than this………..

4. Quality Culture today..
Pharmaceutical manufacturing HIGHLY regulated compared to food, chemical, etc
Cost of cGMP compliance very high
Reasons for manufacturing /testing failures sometimes not understood
The service providers to Formulation industry such as API manufacturers, etc need to be equally regulated
Industry opting for additional systems such as Six Sigma, Lean,etc. sometimes clashing up with methodologies.

5. Expectations for Quality
Are safe
Are efficacious
Have the correct identity
Deliver the same performance as described in the label
Perform consistently over their shelf life
Are made in a manner that ensures quality
Will be available when needed

6. Quality Risk Management
Prime Focus Areas
Quality By Design
Quality Risk Management
Data Integrity

7. Quality By Design
Quality by Design (QbD) is a concept first outlined by quality expert Joseph M. Juran
Benefits of QbD
Improvement in Product Quality and Product Robustness/ Reproducibility
• Improved Development Capability, Speed and Formulation Design
• Cost Reduction Benefits
• Yield Increase
• Fast and Reliably to Market
• Increased Process Capability; Reduced Atypicals
• Reduced Impact of Raw Material Variability
• Improved Product Stability
• Improved Scale Up Efficiency/Speed

8. Quality Risk Management
Risk: Combination of the probability of occurrence of harm and severity of the harm.
Goal is to reduce patient risk
Quality risk management can apply to various quality system but not limited to:
Management Review
Corrective and Preventative system
Complaints
Product Action
Validation/Qualification

9. Data Integrity
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle.
The main criteria for data integrity are listed below
Accurate - No errors or Editing without documented amendments.
Attributable - Who acquired the data or performed an action and when.
Available - For review and audit or inspection over the lifetime of the record.
Complete - All data are present and available.
Contemporaneous - Documented at the time of the activity.
Enduring - On proven storage media (paper or electronic).
Legible - Data can be easily read.
Original / Reliable - Written printout or observation or a certified copy thereof.
Trustworthy - Data and the record have not been tampered

10. Challenges for Quality
Little incentive to upgrade facilities, processes, or knowledge to existing approved products - Perceived as low return on investment
Market does not reward quality
Perceived low enforcement threat
Complexity of handling changes for multiple markets
Fear of discovering a previously unknown issue

11. Challenges for Quality
Lack of “Quality Culture”
Manufacturing objectives targeted to meet market requirements, versus meeting compliance / patient expectations
Can lead to short sighted decision making
People are not designed for perfection!
Even really good people make mistakes!
EVERY error has multiple causes and associated contributing factors
Circumstances and the working environment have a profound impact

12. Future of Quality
Commitment to quality, including: – Establishing effective pharmaceutical quality systems
Invest in quality and continual improvement – Quality can pay for itself!

13. Future of Quality
An environment where each and every person understands and embraces their responsibility for protecting product quality and patient safety

14. Simple fact of Life….. Blame culture Over complexity
We can’t significantly alter people’s behaviour but we can DRAMATICALLY influence their working conditions
So improve on-
Blame culture
Over complexity
Financially driven performance measures
Poor education and training
Focus on cost not quality
Poor change control
Repeat deviations
Lack of process robustness
Disconnected, invisible leadership
Ineffective audits
Demotivation

15. Thank You
Make GMP a lifestyle!!!