After production, we typically subject our products to a batch of quality control assays to ascertain their functionality, efficacy and ability to meet their intended purpose.
Strict quality control is necessary when producing or using enzymes (whether purified or unpurified) and other molecular biology reagents.
Quality control for functionality involves incubating the enzymes or PCR master mix in a PCR reaction mixtures and testing for their ability to amplify a specific region of a DNA template and the results recorded in terms of the presence or absence of amplification by bands on an electrophoresis agarose gel.
The Quality control tests are done at specific regular intervals and results documented for follow up. Incase any product fails the quality control test, actions are taken to verify the cause and make sure it does not repeat.
More than one test may be carried out for a particular product and the quality manager must approve and sign the certificate of analysis (a document that reveals the different quality control tests that have been performed on a reagent) to show that the product passes all the quality control tests assigned for it before a product is released for use.
Quality control of a product is done in two stages - the first involves a batch of tests carried out within the facility where the reagents are produced (Internal quality control) and the second involves testing for functionality by an external facility (External quality control).
In this protocol we describe how to carry out Functionality test of the following: