Pharmaceutical Technologist - March 2008 - (Page 20)

Ranjit Barshikar Changing times The past two decades have seen revolutionary changes in the pharmaceutical industry, and there could still be many more to come. Ranjit Barshikar, GMP/quality consultant and former vice president, global quality Ranbaxy Laboratories examines changes in the Indian and global pharma industries. You have a wealth of experience in the global pharmaceutical industry — what are the main/most significant changes you have seen during the last two decades? Change is good because it encourages self-development. Without it, there would be no progress. Change is always challenging, but the pharma industry is growing and surviving because it is accepting such changes in regulatory requirements and in markets. The last two decades have witnessed many changes including: ● Regulators supporting industry by introducing compliance initiatives such as PAT and quality risk management (QRM). ● More stringent regulations; for example, the introduction of current good manufacturing practice (cGMP) by FDA. ● The compliance efforts made by the industry. ● An increased quality awareness amongst manufacturers to strengthen the business. ● The industry’s shift towards total quality management (TQM) to ensure product safety, quality and efficiency. ● A stronger focus on effective clinical trials. ● Steps towards harmonization of regulatory compliance, and the advancement of International Conference on Harmonization (ICH) Quality topics — Q7a, Q8, Q9 and Q10. ● Improved communication between regulators in different countries. ● Analytical equipment that is 21 CFR Part 11 compliant. ● Improved auditing processes. ● ● ● ● Introduction of e-filing process and common technical documents (CTD). Progress in paperless operations (i.e., electronic documentation systems). Evolution of new markets such as Brazil, China, India, Indonesia, Mexico, Russia and Turkey (E7). Increased outsourcing for R&D, manufacturing, testing and clinical trials activity. Can you elaborate on the latest technologies? The most important change the global pharma industry has witnessed is FDA’s introduction of new initiatives: QRM. FDA introduced this in 2003. It is a systematic approach for assessing, controlling, communicating and reviewing the quality of a drug product during its life cycle. ICH, European Agency for the Evaluation of Medicinal Products (EMEA) and the World Health Organisation (WHO) have also now introduced QRM. Four major steps involved in QRM are: ● Risk assessment: this covers identification, analysis and evaluation of risks. ● Risk control: this takes care of controls, reduction and acceptance of risks. ● Risk communications: sharing information on risk amongst all stakeholders ● Risk reviews: results of risk management processes are to be reviewed to identify what can be learned from the experience. The primary principle of QRM is to evaluate the risk to quality, and how it is linked to the protection of patients. Documentation and efforts must also balance the level of scientific-based risk. The approach is beneficial as it saves time, energy and 20 MARCH 2008 PHARMACEUTICAL TECHNOLOGIST

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Pharmaceutical Technologist - March 2008 Contents News Morpheus Market Watch E-procurement Means Lean Procurement The Rational Enquirer Simulating for Success Q&A

Pharmaceutical Technologist - March 2008

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