There is a need to enable informed risk assessment for maintaining product quality throughout the product life cycle because every product and process in pharma industry is associated with risks to the patient’s health, according to experts who were participating at Merck's ‘EMPROVE Seminar Series’ 2016 held in Mumbai recently.

‘EMPROVE Seminar Series 2016’ which is a flagship programme of Merck chose 'Enabling Informed Risk Assessment' as the theme for the year. EMPROVE, a proprietary service from Merck combines product quality with user-related documentation simplifying rigorous regulatory work for the pharmaceutical industry.

Speaking on the sidelines of the 5th edition of the seminar, Peter Salazar, head of the Process Solutions Business, said, “The seriousness towards risk assessment has increased over the past few years. The milestones in regulatory affairs are changing very fast and so is the objective of this seminar. Enabling informed risk assessment fits well into the need of the hour. Merck as an organisation has always proactively tried and to a greater extent has been successful in addressing the regulation requirements globally to ensure we are future ready for our clients.”

Sushrut Kulkarni, senior vice president and head of pharmaceutical technology centre at Zydus Cadila highlighted that risk assessment covers two main aspects - risk to patient and business risk. Different regulatory bodies have different expectations and regulatory requirements today have become similar to that required for NDAs.

Dr Najib Sehat, head, global regulatory management, Merck - Life science business gave a low down on the topic - EU Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for pharmaceutical excipients. He said, “The European directive 2011/62/EU, known as the Falsified Medicine Directive requires that the pharmaceutical manufacturer has to perform a formalized risk assessment and has to verify the appropriate GMP for excipients.”

He gave insight into the EU Commission’s risk assessment approach to excipient quality. He concluded by mentioning about best practices how pharmaceutical companies can qualify suitable pharmaceutical raw materials used in the final formulation process.

Dr Anjali Apte, founder director, Central Dogma Pvt. Ltd presented studies on recombinant protein production in E. coli with auto inducing medium.

Dr. Nishodh Saxena, vice president (Head Quality and Regulatory), Jubilant Life Sciences Ltd presented practical ways to analyse the risks to quality system, providing guidance along the way to achieving effective and efficient quality management and compliance through quality risk management.

Michael Payne, senior technical bio safety consultant, Merck Lifescience spoke on appreciation of regulatory and compliance needs in process development and scaling up the journey through the clinical trials to full scale manufacturing. He said, “It is important that robust decisions on quality and scaling are made as soon as possible to avoid unwelcome surprises in the middle of clinical trials."

His presentation gave an overview of the current guidance for early stage and the principles and practices that can be used in mid-late stage clinical trials.

Ivy Louis, founder, Vienni Training and Consulting dealt with the topic ‘Quality & Culture –The Interchangeable Ingredient’. She focused on the fact how the culture of the organisation has a huge impact on the quality of work among the employees and how quality and culture are two sides of the same coin.