40 CFR Part 160 Subpart E Standard Operating

40 CFR Part § 160 Subpart E Standard Operating Procedures § 160. 81 1

What is a Standard Operating Procedure? o My Definition n o An established written document that is used to standardize a procedure You can Ask yourself: n n n Have I done this procedure before? Will I do this again? Does it need to be done the same way each time? Do other people need to do it the same way? Do other people need to understand what I am doing? 2

Why do we need SOPs? o Everyone is “on the same page” o No question on how to complete a task o No question on how a task was completed o Anyone can read and understand the procedure 3

What kind of SOPs are needed? o o o o -160. 81(b) lists the minimum. Routine instrument maintenance? Glassware washing? QAU? Computer? SOP for SOPs? Analytical method? Specific procedures for initial research project? 4

GLP Requirements for SOPs o o o Testing facility shall have SOPs Management is satisfied that the SOPs are adequate to insure quality and integrity of data Management approval n o in writing / signatures Significant changes in SOPs shall be authorized in writing by management 5

GLP Requirements for SOPs o All deviations in a study from SOPs shall be authorized by Study Director and documented in the raw data. o Who is responsible for documenting SOP changes? n n n Study Director ? Management ? QAU ? 6

GLP Requirements for SOPs o Each laboratory / study area shall have immediately available SOPs relative to the operations being performed o Published literature may be used as a supplement to SOPs 7

How are SOPs written? o o o User friendly General vs. specific Use of manuals Check lists Dynamic documents n Don’t be afraid to change them 8

Who can / should write SOPs ? o o o Study Director? Management? Quality Assurance Unit? Technician? Janitor? 9

Historical SOPs o SOPs are dynamic documents n o They can / should be changed to meet the needs of the operation All revisions of each SOP including date revised shall be maintained. n n Why? Where? 10

SOP Dissemination o Who gets each SOP o Who disseminates o Hard copies vs. electronic copies o SOP review 11

SOP Exercise / Discussion o o Does it meet GLP standards? Is it a useable document? Any problems? How would you change? 12