The regulations tell companies what they must do, but they don't say how to do it. In short, they are prescriptive, not descriptive. The regulations all call for procedures, so companies are compelled to have them in place. Standard Operating Procedures (SOPs) show how companies apply what the regulations say to their specific operations. As such, they must be clear, they must be true, and they must work together. SOPs also reflect good business because they are safeguards for ensuring that processes and activities occur as they should, so that they yield the same results every time. Surely then, having sound procedures in place makes for good compliance; moreover, and perhaps equally important, they help keep companies on track and functioning optimally. This chapter addresses the procedural infrastructures that companies must have. It answers the following questions:

  1. Why is there so much emphasis on SOPs and where can we find the requirements?
  2. How binding are SOPs for our company?
  3. How can we determine which SOPs we need?
  4. How many SOPs should a company have?
  5. At what point do we need to put SOPs in place?
  6. If we follow the regulations, and do quality assurance audits, will we be compliant?
  7. What are global SOPs?
  8. What are quality manuals, and why do companies have them?
  9. What's the difference between a work instruction, an SOP, ...

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