ABSTRACT
Subpart K of Part 111 is titled Requirements for Manufacturing Operations. In this, §111.353 requires written procedures (SOPs) for manufacturing operations.
The logical and essential starting point for establishing such procedures is to clearly define the product(s) to be made. Once this is done, appropriate specifications can be established for the finished products, the components to be used, and the packaging and labeling. Knowing these items, the necessary manufacturing methods and equipment can be devised or selected. This is often referred to as the design phase, typically requiring input either from the firm’s own Research & Development group, or outsourced as described in chapter 31.
