ABSTRACT

This chapter discusses the importance of well-written standard operating procedures (SOP) and why Hazard Analysis Critical Control Point (HACCP) thinking makes sense even if it is not required for the products being manufactured. Following the discussion on SOP and HACCP, there is a more detailed examination of the importance and organization of quarantine or hold areas, options on organizing the receiving and warehousing areas in a way that meets cGMP requirements and reduces errors (mistake-proofing), as well as lowering indirect costs. This chapter also introduces a Lean thinking principle of the visual workplace.