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47 Watts, D C (2006), PAT An FDA paper presented at the The Heidelberg PAT Conference, Heidelberg, Germany 48 Hussain, A S (2001), Emerging science issues in pharmaceutical manufacturing: Process analytical technologies, paper presented at the Science Board Presentations to FDA, Rockville, MD 49 Chisholm, R S (2001), TQMS, statistically based in-process control with real time quality assurance, the AstraZeneca total quality management strategy, paper presented at the Science Board Presentations to FDA, Rockville, MD 50 Raju, G K (2001), Pharmaceutical manufacturing: New technology opportunities, paper presented at the Science Board Presentations to FDA, Rockville, MD 51 Scherzer, R H (2002), Quality by design: A challange to the pharma industry, paper presented at the Science Board Presentations to FDA, Rockville, MD 52 US.

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Department of Health and Human Services (2004), Risk-based method for prioritizing cGMP inspections of pharmaceutical manufacturing sites A pilot risk ranking model, Food and Drug Administration, Rockville, MD 53 US Department of Health and Human Services (2006), SMG 2020 FDA quality system framework for internal activities, Food and Drug Administration, Rockville, MD 54 US Department of Health and Human Services (2006), Guidance for industry: Quality systems approach to pharmaceutical cGMP regulations, Food and Drug Administration, Rockville, MD 55 US Department of Health and Human Services (2004), Guidance for industry: Sterile drug products produced by aseptic processing Current good manufacturing practice, Food and Drug Administration, Rockville, MD 56 US Department of Health and Human Services (2003), Guidance for industry: Comparability protocols Chemistry, manufacturing, and controls information, draft guidance, Food and Drug Administration, Rockville, MD 57 US Food and Drug Administration (FDA) (2004, Mar), Sec 490.

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And there is more. This list is merely a sampling of the complexities facing the programmer when setting off to load the data warehouse. In the early days of data warehouse, there was no choice but to build the programs that did the integration by hand. Programmers using COBOL, C, and other languages wrote these. But soon people noticed that these programs were tedious and repetitive. Furthermore, these programs required ongoing maintenance. Soon technology appeared that automated the process of integrating data from the operational environment, called extract/transform/load (ETL) software. The first ETL software was crude, but it quickly matured to the point where almost any transformation could be handled.

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100 Process validation requirements for drug products and active Pharmaceutical ingredients subject to premarket approval (CPG 7132c08), FDA, Rockville, MD 58 International Conference on Harmonization (ICH) (2004), Q8: Pharmaceutical development, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva 59 International Conference on Harmonization (ICH) (2004), M4: Organisation of the common technical document for the registration of pharmaceuticals for human use, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva 60 US Department of Health and Human Services (2006), Guidance for industry: Providing regulatory submissions in electronic format Human pharmaceutical product applications and related submissions using the eCTD speci cations, Food and Drug Administration, Rockville, MD 61 Yu, L X (2006), Implementation of quality-by-design: Question-based review, paper presented at the Drug Information Association 42nd Annual Meeting, Philadelphia, PA 62.

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International Conference on Harmonization (ICH) (2005), Q9: Quality risk management, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva 63 International Conference on Harmonization (ICH) (2005), Q10: Pharmaceutical quality systems, nal concept paper, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva..

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