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42(b) Are incoming material and components quarantined until approved for use Are all materials handled in such a way to prevent contamination Are all materials stored off the oor Are materials spaced to allow for cleaning and inspection 211122(d) Are labels for different products, strengths, dosage forms, etc, stored separately with suitable identi cation Is label storage area limited to authorized personnel 21189 Are rejected components, material, and containers quarantined and clearly marked to prevent their use Inventory Control Program 211142 Are inventory control procedures written Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials 211150(a) Is stock rotated to ensure that the oldest approved product or material is used rst 211.

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, Improving performance and reducing cycle time using ow path management: A case study, Pharm Eng 21 34 Abboud, L, and Hensley, S (2003), Factory shift: New prescription for drug makers: Update the plants, Wall Street J, Sept 3, p 1 35 Cooley, R E, and Egan, J C (2004), The impact of process analytical technology (PAT) on pharmaceutical manufacturing, Am Pharm Rev, 7, 62 68 36 Cogdill, R P (2006), in Brittain, H G, Ed, Spectroscopy of Pharmaceutical Solids, Taylor & Francis Group, New York, pp 313 412 37 Cogdill, R P, et al, (2005), Process analytical technology case study, Part II: Development and validation of quantitative for tablet API content and hardness, AAPS Pharm Sci Tech, 6, Article 38 38 Cogdill, R P, et al.

Special notes: This diagram does not emphasize the fact that a Manager is also a Salesperson so a manager could play the role of the Salesperson in the diagram. You could add the Manager Works Shift relationship but that would complicate the diagram.

184(e) Is destruction of materials documented in a way that clearly identi es the material destroyed and the date on which destruction took place Vendor (Supplier) Control Program Are vendors periodically inspected according to a written procedure Is the procedure for con rming vendor test results written and followed Operational control Yes, No, or NA.

, (2005), Process analytical technology case study, Part I: Feasibility studies for quantitative NIR method development, AAPS Pharm Sci Tech, 6, Article 37 39 Cogdill, R P, Anderson, C A, and Drennen, J K (2005), Process analytical technology case study, Part III: Calibration monitoring and transfer, AAPS Pharm Sci Tech, 6, Article 39 40 Lorber, A (1986), Error propagation and gures of merit for quanti cation by solving matrix equations, Anal Chem, 58, 1167 41 Braga, J W B, and Poppi, R J (2004), Figures of merit for the determination of the polymorphic purity of carbamazepine by infrared spectroscopy and multivariate calibration, J Pharm Sci, 93, 2124 42 Lunney, P, and Drennen, J K I (2005), A prevention based strategy for quality control using PAT, NIR News, 16, 7 43 Sandell, D, Diener, M, Vukovinsky, K, Hofer, J.