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40 CFR Part § 160 Subpart E

40 CFR Part § 160 Subpart E. Standard Operating Procedures § 160.81. What is a Standard Operating Procedure?. My Definition An established written document that is used to standardize a procedure You can Ask yourself: Have I done this procedure before? Will I do this again?

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40 CFR Part § 160 Subpart E

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  1. 40 CFR Part § 160Subpart E Standard Operating Procedures § 160.81

  2. What is a Standard Operating Procedure? • My Definition • An established written document that is used to standardize a procedure • You can Ask yourself: • 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?

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

  4. What kind of SOPs are needed? -160.81(b) lists the minimum- • Routine instrument maintenance? • Glassware washing? • QAU? • Computer? • SOP for SOPs? • Analytical method? • Specific procedures for initial research project?

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

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

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

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

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

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

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

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

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