Pharmaceutical quality system development

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. 

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

A consensus vision statement was drafted at the July 2003 ICH meeting with regard to the objective of the ICH in harmonizing the efforts of regulatory bodies to establish quahty systems approaches in their operations Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science. ... 

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). 

With the development ICH QIO (see Sects. 35.5.9 and 35.7.4) as a standard for a pharmaceutical quality system, the process approach (maintenance as well as improvement) was emphasised. QIO states as well that a PQS should cover the whole product life cycle. This section describes the product life cycle of medicines, for preparation in pharmacies as well as for industrial production. A medicine whether developed in a pharmacy or in industry is designed to meet the needs of the patient and starts with clarifying that need. The product life cycle consists of a series of processes that need to be controlled and continually improved in order to deliver products with the intended quality. 

While the foundation of QbD was laid in the FDA guidance documents, the paradigm shift continued to evolve through the release of three ICH documents (described later) ICH Q8(R1), Pharmaceutical Development, ICH Q9, Quality Risk Management, and ICH QIO, Pharmaceutical Quality Systems. ... 

ICH QIO illustrates a model for a pharmaceutical quality system that can be implemented throughout the lifecycle of a product. This primary objective is achieved through the implementation of three specific goals, including (1) establish, implement, and maintain a system that ensures the delivery of high-quality drug product with the appropriate quality attributes to consumers (2) develop an effective monitoring and control system that continually assesses process performance and product quality and (3) continually identify and implement... 

The pharmaceutical quality system should be applied throughout all stages of the product s lifecycle, including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. ... 

C. C. Chan and E. Jensen, Overview of pharmaceutical product development and its associated quality system, in Analytical Method Validation and Instrument Performance Verification (eds. C. C. Chan, H. Lam, Y. C. Lee and X.-U. Zhang), Wiley-Interscience, Hoboken, NJ, 2004, pp. 1-10. 

OVERVIEW OF PHARMACEUTICAL PRODUCT DEVELOPMENT AND ITS ASSOCIATED QUALITY SYSTEM... 

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