Title: 1.4 SOP and GMP Training
Course: ATEP - Biotechnology Module B > Section: Course Safety and Training

1.4.1 GMPs and SOPs

SOPs

As you learned in the Tech Park and in Lesson 13.1, Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP) are important in laboratory and production environments to ensure consistency, safety, sterility and quality. Both GMPs and SOPs should be used when producing your product in the classroom. Review Lesson 13.1.3 to identify the common parts of an SOP document and record them in your design journal for future reference.

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1.4.2 Writing an SOP

Writing Your Own SOPs

There is no federally approved format for a SOP but there are expectations within the industry of what an SOP should include. For this reason, SOPs may appear to be in different formats but they all contain the same information. Most importantly is the procedure section of an SOP which is used to ensure all technicians use the same process in the operation of equipment or production of a product.

Using the sample SOP found in Module A Lesson 13.1.3 and the template below, complete the assignment located at the end of this page.

SOP Template

Assignment

1.4.3 Practicing GMPs

Good Manufacturing Practices (GMP) help to provide products that are safe, effective and reliable.

Today, we assume that drugs are highly regulated by the Federal Government through the FDA for safety and effectiveness. Unfortunately, this is not the case. Often, federal regulations, like GMPs, are created in response to tragedies.

Review GMPs found in Module A Lesson 13.1.2 then complete the assignment titled "Popcorn GMP" .