Pharmaceutical Technologist - March 2008 - (Page 21)

Q&A money. It can also avoid problems and issues in manufacturing, and ensure compliance and quality of products. FDA has suggested various management methods to minimize the risks of noncompliance. They help to provide a scientific and practical approach to decision making by providing documented, transparent and reproducible methods to accomplish QRM (see sidebar “Methods to accomplish QRM”) PAT. This FDA initiative was introduced in September 2004 to help the industry understand its manufacturing processes. Dr Ajaz Husain, former FDA deputy director, and architect of PAT, believed that it would take the industry to a “desired state”, as process understanding is a foundation for innovation and continuous improvement in R&D and manufacturing. It is now a part of cGMP, and ICH also emphasizes the need to adopt an integrated, quality by design (QbD) approach to ensure an effective quality manufacturing system. PAT has huge benefits (see sidebar “The benefits of PAT”) and ensures the continuous control of processes and the timely availability of quality products to market, which results in satisfied customers. This is a step towards real time release. Additionally, PAT improves profit after tax because of increased productivity, and minimum reworking and rejections of products. What is the best way to implement PAT? Personally, I believe there are many ways forward, including: ● Developing an integrated scienceand technology-based platform in the organization. ● Creating awareness of QbD and science by design across all aspects of a product’s life cycle. ● Understanding each step of the manufacturing process before implementation. ● Developing a culture of ‘right first time and every time’. These can be supported by the following road map: Training and knowledge of PAT and its benefits for all concerned, including the finance head whose final clearance is needed for investments. ● Identify which technologies will be used. ● Focusing on the complete process — from API to finished product. ● Manufacturing with Six Sigma mentality. Ideally, a PAT team should be developed that involves manufacturing, R&D, QA, quality control (QC) and regulatory departments. Additionally, a strategic initiative leader should be identified who can successfully implement PAT. Trust and mutual understanding will help the team to work quickly together, and good coordination is necessary for effective performance. Depending on the product, the team will decide which PAT tools should be utlilized. Various options are available to help measure or analyse the products on line, such as near infrared, colour imaging techniques and Raman spectroscopy. ● and cost-effectiveness of new molecules: it will be essential for the industry to focus on targeting diseases rather than molecules. During the last few years, some products have been withdrawn from the market because of serious adverse drug reactions (ADRs). It is essential to focus on clinical trials and transparent data. PAT ensures the continuous control of processes and the timely availability of quality products to market, which results in satisfied customers. R&D focus will shift to prevention rather than cure. During my last visit to Shanghai (China), the government was encouraging companies to focus on R&D and to explore predictive medicines. These medicines involve studying genomes to predict diseases that a person is likely to have, and then developing these medicines in advance. Some R&D organizations have already conducted trials for human diseases, with encouraging ● How do you see the industry shaping up during the next decade? There will be major changes during the next 10 years, including an evolution of new markets. By 2020, the emerging markets of the E7 countries could account for 20% of global sales. According to the report Pharma 2020 — the vision, published by PricewaterhouseCoopers, the global population is projected to rise from 6.5 billion in 2005 to 7.6 billion in 2020. The ageing global population will increase by approximately 9% in 2020, leading to a dramatic increase in the requirements of medicines. Global warming will also have effects on human health by 2020. In short, these changes will create new openings for the pharma industry. By 2020, the global pharma market is expected to be worth approximately $1.3 trillion, with China and India in the top 10 largest markets by sales. There are also other important changes that may happen: ● More stringent scrutiny regarding the safety, efficacy Methods to accomplish QRM ● ● ● ● ● ● Failure mode effects analysis evaluates and guides us to the potential failure modes for processes, the factors causing these failures and the likely impact on products. Failure mode effects and criticality analysis helps identify places where additional preventive actions might be appropriate to mitigate risks. Fault tree analysis identifies the root causes of an assumed failure or problem. Hazard analysis and critical control points are approaches that apply technical and scientific principles to analyse, evaluate, prevent and control the risk of hazards because of design development, production and use of product. Preliminary hazard analysis is a method of analysis based on applying previous experience or knowledge of hazards to identify future hazards. Supporting statistical tools enable effective data assessment and aid in determining significance of data sets. www.ptemagazine.com 21 http://www.ptemagazine.com

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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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