In a remarkably short time, Ranbaxy Laboratories has become a force to reckon with in the pharmaceutical industry. Established in 1961, the company operated only in India until the early 1990s, when its founder, Dr. Parvinder Singh, set it on a path toward becoming a global company focused on research and development. Ranbaxy now operates 19 manufacturing facilities in seven countries, including four plants in the U.S.

Ranbaxy’s mission is nothing less than to become one of the world’s top five generic drugmakers, with $5 billion in sales, by 2012. How does such concentrated growth challenge Quality Control and Quality Assessment? We asked Ranbaxy’s Global Quality Chief Ranjit Barshikar to share his insights, thoughts on 21st Century GMPs, ICH and the changing role of pharmaceutical quality operations.

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P.M.: When did Ranbaxy first begin to align its quality efforts with its growth plans?

R.B.: To help fulfill its mission of becoming a research-based international pharmaceutical company, Ranbaxy began its quality efforts in the early 1990s, through a corporate quality assurance group operating from its R&D center. This has since grown to a 700-person organization. The global quality team reports directly to CEO Dr. Malvinder Singh.

P.M.: What are the greatest challenges that your team faces today?

R.B.: We strive to integrate our quality organization, seamlessly, with other operational teams within the company. Global growth also brings with it the need to manage cultural diversity and to keep ahead of the different product specifications and packaging requirements in different regions. Conducting technical due diligence is another challenge, but we have a team in place that manages all these issues well, on an ongoing basis.

P.M.: How can a corporate quality program be strong, yet flexible enough to accommodate different regulations, cultures and mindsets?

R.B.: We believe in having a global outlook, but implementing locally, so we customize our strategy for each country in which we operate. Typically, we first deploy a set of corporate guidelines on cGMPs that are in line with international requirements. Then, after studying and discussing country-specific requirements with local staff, we address them through local standard operating procedures (SOPs).

Our global quality team takes a systematic and methodical approach to minimizing risk, and ensures that reviews are conducted regularly by skilled and highly trained staffers. Our R&D team helps the quality team keep up with frequent changes in pharmacopeial specifications, another challenge.

P.M.: How do you verify that quality standards are being met?

R.B.: The quality team performs audits periodically to facilitate and verify cGMP compliance across all manufacturing sites, and to ensure that both corporate guidelines and local regulations are being followed.

Quality systems are in place, and are monitored regularly by cross-functional teams, and our manufacturing facilities and clinical facilities are approved by FDA, MHRA and other global regulatory agencies.

Training is very important. We organize for the QA and QC staff, corporate training and conferences, and we offer a variety of Web-based training courses to help them keep up to date on technical and regulatory requirements, and sharpen their skills. We have very good support from Global HR in training activity.

P.M.: Has Ranbaxy incorporated the spirit of 21^st century cGMPs and “risk management” into its compliance programs?

R.B.: We support the risk-based approach and Process Analytical Technology (PAT), both of which should help the industry develop in a way that benefits the consumer and improves product safety. We also support ICH Q9 guidelines. In fact, our company has action plans to adopt these guidelines for the benefit of patients who use our drugs.

Ranbaxy formally incorporated the concept of risk-based compliance a few years ago, during an internal QA staff meeting devoted to “risk mitigation.” Our goal was to generate awareness of risk-based compliance within the quality team, and have each member of the team serve as an ambassador, to communicate the relevant messages to manufacturing, R&D and other departments. Our goal is to continuously identify risks, assess their potential impact and mitigate their effects.

This approach has helped us to build and strengthen a “Quality by Design" culture within Ranbaxy.

P.M.: How are you incorporating PAT into your efforts?

R.B.: We’ve formed a global PAT task force whose members come from QA, manufacturing and R&D. We started our PAT efforts off-line, using NIR, and developed testing procedures for both active pharmaceutical ingredients and finished products.

So far, we have successfully implemented over 50 PAT projects, off-line, and this is only the beginning. We’ve discussed the technical and other challenges of in-line monitoring with FDA as well as International Society for Pharmaceutical Engineering ( ISPE), and have plans to install in-line PAT at R&D and manufacturing lines, in phases. We also see to it that our staff participate in various PAT-related conferences as part of their education and training.

P.M.: What role will automation play in QA in the future?

R.B.: Its role is vital. We’ve already installed Documentum (EMC Corp., Pleasanton, Calif.) automated document management systems as well as instrument networking systems to enhance productivity and reliability, and plan to move to paperless laboratories, using e-notebooks, in the future.