In order to help participants improve their practice and reporting of quality metrics to US FDA, the Indian Pharmaceutical Association (IPA) Industrial Pharmacy Division in association with IPA-Gujarat State Branch, Gujarat Food and Drug Control Administration (FDCA) and Pharmaceuticals Export Promotion Council of India (Pharmexcil) is organising IPA-Pharmexcil technical conference 2017 on 28th January 2017 in Ahmedabad under the theme ‘Quality Metrics - Future need of the Pharmaceutical Industry for marketing drug products in the US market’.

This will help small to medium scale entrepreneurs and academicians to understand the requirements of quality metrics and voluntarily start the practice of quality metrics.

Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.

FDA Guidance on quality metrics, which is now a revised draft guidance, includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

In order to achieve these goals, FDA is initiating a quality metrics reporting programme. As described in this guidance, FDA is initiating a voluntary reporting phase of the FDA quality metrics reporting programme. In the voluntary reporting phase of the program, FDA expects to learn more about a limited set of quality metrics, associated analytics, and improve the FDA quality metrics reporting programme.

The goal of FDA is to provide drug products with high and consistent quality. Quality metrics are introduced because product recalls are increasing despite elaborate QC/QA monitoring by most companies. QM's are expected to check the consistency of processes and quality of the marketed drug products. FDA intends that lot acceptance rate, product quality complaint rate invalidated out of specification rate and annual product review (APR) or product quality review (PQR) in time rate be calculated. The optional metrics are CAPA effectiveness and calculation of Cp and Pp objectives of seminar

Seminar will have presentations on meaningful quality metrics for sustainable compliance by S.M.Mudda , executive director (technical operations), Micro Labs Ltd, Bangalore; product quality review by Sanjay Kumar Jain (vp-quality), Amneal Pharma, Ahmedabad; Quality Metrics- A tool to evaluate our quality system by Sanjay Kapadia, president - corporate quality assurance, Ipca Laboratories Ltd, Mumbai; Data Integrity : An overriding factor for Quality Metrics by Vijay Kshirsagar, director, TRAC Pharma Consulting, Mumbai; Calculation of Quality Metrics by Dr. M.C.Gohel, research director & professor, Anand Pharmacy College, Anand; and Review of Pharmaceutical Quality Systems including KPI by Shailesh Patel, head- quality & regulatory affairs- Cadila Pharmaceutical Ltd, Ahmedabad.