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increased sharing of information and harmonization of activities The International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (wwwichorg) has been the dominant mechanism for international cooperation among pharmaceutical regulatory authorities in Europe, Japan, and the United States 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 quality 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.
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Three consensus guidelines de ne 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: Speci cations: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances) Q8: Pharmaceutical Development According to the ICH Q8 guideline [58], the aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner While QbD is not speci cally mentioned in the guideline, the intent of the ICH Q8 expert working group (EWG) was to describe a system that would provide incentive for manufacturers to incorporate aspects of QbD and continuous improvement throughout the product life cycle.
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Techniques for boosting the profitability of online activities include ensuring that there is a clear focus on people. O n e popular and effective idea to consider is recriiitiiz,. nrz e-hmiiiess e . q k r t , someone with experience w h o can take a fresh perspective o n all aspects of your e-business activities. This may not need t o be a permanent appointment and there are many consultancies that can provide this type of input, although it may be quicker, easier and more beneficial to appoint an individual w h o can fit within the organisation structure. T h e success of this idea, however, relies on the stage of development reached by the e-business: clearly, it is best suited to the organisation that is about t o start a new phase of e-business activity.
In achieving this goal, the guideline they produced describes the suggested contents for Section 32P2 of a regulatory submission in the ICH M4 common technical document (CTD) [59] and the FDA electronic common technical document (eCTD) [60] The pharmaceutical development and quality overall summary (QOS) sections of the CTD (Figure 10) provide pharmaceutical scientists with dedicated channels to present regulators with the relevant knowledge and process understanding gathered during the development of a new product (which can be updated to support new knowledge gained over the life cycle of the product following approval) The knowledge communicated within these sections are important considerations for justi cation of a lower site risk potential (ie, SRP, with regard to risk-based inspection) and for facilitation of ef cient, question-based review (QbR) [61].
P1: KOA WY050-03 WY050-Ulick-v4 September 19, 2004 10:58
Questionbased review is another mechanism by which the agency intends to streamline the regulatory process as well as reward producers for adopting best practices in quality management In addition to facilitating risk-based oversight, the content of the pharmaceutical development and QOS sections of the CTD are critical to enabling continuous improvement and exible operation The information and knowledge communicated within these sections provide scienti c understanding to support the establishment of a manufacturing design space, in-process and release speci cations, and manufacturing controls As described within the Q8 guideline, a design space is the multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality So long as process control is maintained within the bounds of the design space, operating parameters can be adjusted to improve product quality or manufacturing ef ciency Based on the.
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