Pharmaceutical Quality Management

In practice pharmaceutical quality management systems (PQSs) may follow the structme of quality standards for medicines, mainly GMP, PIC/S-GPP, and QIO to which GMP is referring. These standards are described as well as standards that are more applicable to preparation in the pharmacy i.e. the Ph. Eur. monograph Pharmaceutical Preparations, the Council of Europe (CoE) Resolution and USP Compoimding Standards. If a PQS has to cover the complete life cycle of the product, preparation in pharmacies or even all pharmacy activities then a more universal structure such... 

The perfect pharmaceutical quality management system - does it exist Interview with Dr. Tom Duffy, Lowden International, www. lowdenintemational.com. Pharmafile 11/2011... 

To facilitate industry application of modern quality management techniques, including the implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance. 

Quality Ten topic headings—Stability, Analytical Validation, Impurities, Pharmacopoeias, Quality of Biotechnological Products, Specifications, GMP, Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality System total of 24 guidelines... 

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

External Quality Management Systems The FDA has published a guidance on a quahty systems approach to pharmaceutical cGMPs. 

ICH Q8(R1) Pharmaceutical Development, Nov. 2008 ICH Q9 Quality Risk Management, Nov. 2005 ICH QIO Pharmaceutical Quality System, June 2008. 

In some pharmaceutical companies and institutions, the principles of total quality management (TQM) or philosophies associated with... 

This book was designed and written for validation professionals responsible for writing and maintaining quality management systems for the successful operation of their companies. It provides a set of SOPs that can be used to manage and document critical validation and revalidation tasks in a pharmaceutical manufacturing facility. 

GUIDING PRINCIPLES Encourage new technological advances State-of-the-art pharmaceutical science Risk-based approaches focus industry and agency attention on critical areas Eacilitate industry application of modern quality management Enhanced quality systems approaches into the agency s business processes... 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

ANALYTICAL AND COMPUTATIONAL METHODS AND EXAMPLES FOR DESIGNING AND CONTROLLING TOTAL QUALITY MANAGEMENT PHARMACEUTICAL MANUFACTURING SYSTEMS... 

The main problems when applying a traditional quality management philosophy to any pharmaceutical design/manufacturing/assembly challenge include the following ... 

This chapter will outline the concepts, benefits, and practical implementation steps for developing a comprehensive quality management system (QMS) that supports pharmaceutical and biopharmaceutical manufacturing operations. The material presented is universal in its utility, applicable to small and large companies, development, and commercial enterprises. A QMS is aproactive,structured approach... 

Many of the quality improvement goals for implementation of PAT in the pharmaceutical industry have been achieved by companies in other industries, such as automobile production and consumer electronics, as a direct result of adopting principles of quality management. The lineage of modern quality management can be traced to the work of Walter Shewhart, a statistician for Bell Laboratories in the mid-1920s [17]. His observation that statistical analysis of the dimensions of industrial products over time could be used to control the quality of production laid the foundation for modern control charts. Shewhart is considered to be the father of statistical process control (SPC) his work provides the first evidence of the transition from product quality (by inspection) to the concept of quality processes [18,19]. 

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