SMB Validation

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.