Topic: Etanercept

-SOP focus in Downstream Purification Process ( does not need to be detail for the whole process, but focus mainly in ONE STEP (can be fermentation) and briefly describe the rest).

Facilities and Equipment(A specific SOP might cover Facility Start Up and Shut Down , Qualification of Equipment, Waste Control and Management, Environmental Monitoring, Storage in Fridges / Freezers, or Equipment cleaning and storage etc.)

Powerpoint, APA format, In-text citation, 8 slides( not include references page), reference include.

For each SOP please include:

• Author
• Purpose
• Scope
• Audience
• Graphical outline of steps (e.g. flowchart)
• Equipment and supplies
• Methodology and procedures
• Critical limits / regulatory criteria
• Record keeping
• Quality assurance / quality control
• Health and safety considerations (e.g. disposal of materials)
• References (these can be included in the notes of the Powerpoint)

Here are some examples of SOPs that you can use as references for the type of content and how to present a SOP; some links may be problematic.

• http://www.who.int/hiv/pub/drugresistance/HIVDR_Mod_10_SOPs.ppt
• http://www.haccpalliance.org/sub/food-safety/guifinal2.pdf
• http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/s20085en.ppt?ua=1
• http://pdf.usaid.gov/pdf_docs/Pnadf783.pdf
• http://www.feedhaccp.org/distance/elearning/haccp/sops/sops.pdf