1 / 37

QC of Examination Phase

QC of Examination Phase. QC of Examination Phase. Method for Selection & Validation Of Laboratory Test Documentation of Procedures (SOP) Assuring Quality of Examination. What is an SOP?. WHAT IS AN SOP?

aysel
Download Presentation

QC of Examination Phase

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. QC of Examination Phase

  2. QC of Examination Phase • Method for Selection & Validation Of Laboratory Test • Documentation of Procedures (SOP) • Assuring Quality of Examination

  3. What is an SOP?

  4. WHAT IS AN SOP? A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation

  5. WHAT IS AN SOP? An established written method for performing a operation to achieve uniform performance of the task. ICH E6 Good Clinical Practice: Consolidated Guidance OR OR

  6. Goal of SOPs

  7. Give Me Some Examples

  8. Why Write SOPs?

  9. SOPs Value

  10. SOPs’ Also Ensure • Worker safety • Optimize operational and production requirements

  11. SOPs’ Value SOPs form the foundation of training

  12. POLICY SOP

  13. Give Me Some Examples

  14. FORMAT GP2-A5 Title: Clear and Descriptive Author: Identify major contributor(s) Date: Introduction and at each revision Sequence: Logical numbering system Resources: reagents, equipment

  15. TITLE Describe in sufficient detail the focus of the SOP so that anyone can tell from the title the content of the SOP

  16. Title: Examples

  17. PURPOSE This section describes what is to be accomplished by this procedure. Often times this is very similar to the title.

  18. SCOPE The scope defines the area to which the SOP applies.

  19. RESPONSIBILITY This states who has responsibility for training and execution of the SOP

  20. REFERENCES List all references that serve as the basis for the SOP

  21. DEFINITIONS List all definitions that are essential to an understanding of the SOP including all acronyms

  22. ATTACHMENTS Any forms, logs or other documents that are essential to the execution of the SOP and mentioned in the SOP is attached to the SOP

  23. REVISION HISTORY This will include a detailed list of what changed in the revision. It is extremely important to know what changed and when Remember:Staff must be trained after revision has occurred.

  24. REVISION HISTORY 8.0 Revision History Example

  25. Parting Points

  26. Parting Points

  27. Parting Points Avoid Jargon Define Abbreviations

  28. Parting Points Remember AVOID

  29. Structuring SOPs

  30. Structuring SOPs

  31. Structuring SOPs

  32. Structuring SOPs

  33. Structuring SOPs

  34. Structuring SOPs NOTE 1: Current document does not include information on serial testing algorithm or NOTE 2: Information in section 8 of v1.0 may be invalid.

  35. QUESTIONS?

More Related