1 / 12

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?

Rita
Télécharger la présentation

40 CFR Part § 160 Subpart E

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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?

More Related