cGMP-compliant SOP revision . Change in SOPs is part of manufacturer’s attempts for continuous improvement of a process or product. PAGE gels can be cast by an analyst (video 1 – mostly FYI), but a faster, more reproducible way is to buy pre-cast gels (used in video 2). In this exercise, you, the QC analyst, are preparing a draft of a proposed revision of your current SOP for detecting a protein product, to an improved one that uses pre-cast gels.

Pick a name for your biotech company. For your revised cGMP compliant SOP, combine the instructions from video 2 for SDS-PAGE, with the instructions for Western blotting given below in text. Video 3 is provided to help you see and understand the Western steps. You will have to stop at step 9 (or 8) of video 2 and continue on to the appropriate Western Blotting step in the provided Western Blot protocol. Note that the Western Blot protocol below is missing parts of what will be considered a cGMP-compliant SOP format – you will have to add those missing parts. You can follow the content and format of an SOP in the “Label control SOP” and in the “SOP Stability Cougar”. Also look for the parts of a cGMP-compliant SOP from lecture ppt 05 on quality documentation. You will have to come up with your own reason/objective and your source of recombinant protein that you will be detecting for your Western. The protein that you are detecting can be from a bacteria, yeast, any plant, any animal, human, etc. You are all expected to work on different proteins. Also do a google search for a vendor/source of antibodies to detect your protein. The cGMP-compliant SOP revision assignment needs to be 4 pages.

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