Understanding facility validation for GMP compliance

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

J. Ramniwas

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

In the past decade, many far-reaching changes have taken place in the application of cGMP regulations relating to the pharmaceutical industry. Continuous quality improvement thus is ingrained in the cGMP concept. The design, construction, commissioning, and validation of pharmaceutical facilities play very important role in the risk mitigation of product Quality and Safety. Among the six GMP systems of US FDA requirements for facility system are particularly important for pharmaceutical companies to understand and implement this GMP requirement therefore constructing new facilities and reconstructing the existing ones both require the compliance with the GMP. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that the facility suitable for the intended use for manufacturing, testing, storage meeting GMP requirements.

Biography :

J.Ramniwas has total more than 21 years of experience of working in various Pharmaceutical industries. At present he is the chief executive officer at Sai Pharma Solutions Inc. located at Vadodara, India which is a gateway to the Regulatory Affairs, Quality and cGMP compliance. His experience includes Regulatory Affairs, Analytical Development and Validations, Quality, Establishment of Quality Systems, Regulatory and GMP trainings, Qualifications and Validations of Facilities, Equipments and Utilities, GMP Documentation, Auditing, Regulatory Submissions, Hosting customer and Regulatory Audits, Risk Management and Compliance to Global Regulatory requirements. His articles pertaining to Regulatory Affairs and cGMP compliance issues have been published by many leading pharmaceutical magazines. He is one of the renowned international speaker on GMP and Regulatory Issues.