GMP -Regulatory Perspective Sukanti Borkar Abbott India Ltd.

Content Quality Culture today Challenges for Quality Future of Quality

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………..

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.

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

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

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

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

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

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

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

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

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

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

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