Advances & New Frontiers in Sterile Manufacturing Technology

17th & 18th April 2020, Mumbai, India

Pharmaceutical Product Quality: Visual Inspection

DR. A. RAMA MOHANA RAO, – Chief Quality Officer –Aurobindo Pharma

Visual inspection continues to be an important element of the manufacturing process and the quality assurance of injectable products. Product inspection provides necessary information for lot release, and, coupled with defect identification, contributes to a strategy of continuous process improvement.  Inspection may be accomplished manually or using a variety of automated inspection technologies. Particulate matter in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. 

This session will cover the latest trends in visual inspection including the regulatory and compendial requirements that govern the inspection process. Specifically, the implementation of life cycle approach to visual inspection and defect control will be discussed. Manual inspection continues to provide the critical reference method for all compendial inspection activity. This session will also look at use of particle standards to qualify manual and automated inspection systems. The control of critical inspection parameters and the development of an inspection method for difficult to inspect products. Also, the holistic VI process will be covered with discussions on control strategies such as AQL and defect trending. Key elements of a basic inspection, visual inspector qualification program and sampling process along with special considerations for difficult to inspect parenteral (DIP) products will also be covered. 

Dr. A. Rama Mohana Rao has received his Ph.D in Pharmaceutical Analysis from Andhra University in 1988. He was awarded best thesis in 1987-88 from Andhra University for his research work. Prior to moving to Aurobindo, he worked with Ranbaxy laboratories Limited, Cadila Pharmaceuticals and Biological E. Limited in senior industry positions.

As of 2001, Dr. Rao has been working with Aurobindo Pharma Ltd, he has 31 years of experience in various disciplines in the Pharma industry. Dr. Rao is the Chief Quality Officer, managing quality related functions of the company which include design and implementation of a plethora of company wide quality policies and procedures. He has been instrumental in implementation of several automations to enhance paperless systems within the firm thus allowing for a reduction in human errors. He has expertly navigated various inspections of regulatory bodies such as USFDA, MHRA and ANVISA to name a few.