Standard Operating Procedures (SOP) are prepared for each critical utility or piece of equipment to provide all personnel working with the equipment information and instructions on what is required in order to maintain, operate, and clean the utility or piece of equipment. The procedures will document maintenance schedule requirements and specific products required to ensure the proper operation and longevity of the utility or piece of equipment. Operation procedures are also documented in the SOP giving specific instructions on correctly setting up and operating the utility or piece of equipment. Cleaning procedures are also included as part of an SOP which detail instructions on how to correctly disassemble and re-assemble components, required cleaning procedures, and cleaning agents. Abrasive cleaning agents may damage certain materials of construction; the SOP will specify the recommended cleaning agents as required.

Why produce a SOP?

Standard Operating Procedures are required in order to ensure the safety of both the operator and utility or piece of equipment. SOP’s follow Current Good Manufacturing Practices (cGMP) in ensuring that all personnel involved in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (ref: § 211.25 Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals, Subpart B). SOP’s detail the required steps to ensure that the utility or piece of equipment is operated correctly. SOP’s can be used as a training tool and will be used by every person responsible for any aspect of the utility or piece of equipment.