Pharmaceutical Technologist - January 2008 - (Page 27)

*Gerald Heddell Checks and measures The pharmaceutical industry is one that must continually evolve to satisfy the demands of both manufacturers and patients. So how is the MHRA dealing with today’s challenges of quality assurance, counterfeit drugs and supply chain issues? Gerald Heddell, director of the inspection and standards division at the MHRA, enlightened Pharmaceutical Technologist. What are the objectives of the MHRA and what services does the agency offer? The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body that was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). These include the regulation of medicines, medical devices and equipment used in healthcare, and the investigation of harmful incidents. The MHRA now also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organizations to regulate blood quality and safety. The principal aim of the agency is to safeguard the public’s health. It does this by making sure that medicines and medical devices — from painkillers to pacemakers — work properly and are acceptably safe; and by responding promptly when new concerns come to light. No product is completely free of risk, but sound evidence underpins all the MHRA’s decisions to ensure that these risks are minimized. There are several ways in which the agency checks the safety and quality standards of healthcare products, and ensures that they comply with European and UK laws and regulations. Regular inspections play a key role in ensuring the quality of products. Inspections cover all aspects of a medicine’s life cycle including preclinical studies; clinical trials; manufacture and supply; distribution; and storage and laboratories testing. As well as its own inspection teams and proactive monitoring, the MHRA relies on manufacturers, healthcare professionals and the public to report defects, side effects and misleading information. What trends in quality assurance has the agency seen? Recent years have shown an increasing emphasis on the importance of robust quality systems. Whilst having a quality system has always been a core element of EU GMP, regulatory authorities, including the MHRA, are placing greater emphasis and recognition on the fact that good practice is dependent on integrated policies, processes and procedures. The most common deficiencies found in MHRA GMP inspections now relate to inadequacies of the quality system. The application of a robust quality system, together with improved product knowledge and quality risk management (ICH Q8 and Q9) are expected to be important factors in the development of new variations regulations. ICH Q10, which is currently being developed, further supports this emphasis. Together with Q8 and Q9, Q10 will hopefully assist in the modernization of the approaches by companies and regulatory authorities in achieving the goal of a modern science and risk based pharmaceutical industry. As the MHRA implements a risk-based approach to inspections from this year, I expect the maturity of a company’s quality systems to be a key factor in our risk assessment. What are your thoughts regarding ingredients and finished products coming from Asia (particularly China) and Eastern Europe? Finished products coming from Asia and Eastern Europe are subject to the same licensing requirements as products from the UK. The MHRA recognizes the trend towards global sourcing and is responding with a rigorous assessment and inspection regime that www.ptemagazine.com 27 http://www.ptemagazine.com

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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