SOP (Standard Operating Procedure)

Documented steps for consistent task execution

SOPs are established or prescribed methods to be followed routinely for the performance of designated opeatons or in designated situation. Each cleaning process should be documented in an SOP per PICS PI 006-3. According to PDA TR29, draft SOPs should be an output of the design and development stage of cleaning validation. ISPE states that the output of the qualification stage of cleaning validation is final, complete SOPs.