Gmp Regulations

Biologics are recognized as cutting edge products utilized against many hard to treat diseases and conditions. The physical properties of biologics as well as the nature in which they are produced make the regulations that govern these products very complex and important to understand. Biologic are often complex, large, and unstable 3D compounds that can be easily altered by natural factors such as holding temperature and light exposure (Geigert, 2013). This can be troublesome for biologic manufacturers attempting to produce and replicate a therapeutic product that carries a narrow therapeutic window and associated risks of immunotoxicity. Current good manufacturing practices or cGMP’s must be followed to ensure that during the production
The FDA supplements standard cGMP regulations found in 21 CFR 211 with biologic product specific cGMP’s found in 21 CFR 600. The additional regulations cover specific concerns such as temperature holding, animal processing, and vaccine processing among other issues. Three of the most important aspects of both GMP regulations in relation to biologic production are the materials management, process validation, and change protocol. The importance of raw material management in the production of biologics cannot be understated. Associated risks with the various biological raw materials are: prions, mycoplasmas, bacteria/fungi, and viral infection. All of these are incorporated into possible adventitious agents, which can be found in final biologic products (Geigert, 2013). Proper steps need to be taken to ensure that the raw materials being used are not contaminated with possible adventitious agents. It is possible that viral DNA can be transmitted through cell lines, which can produce unknown responses in a patient if administered. FDA guidance states that proper a properly designed quality system can help determine if raw materials contain any adventitious agents, especially when utilizing cell substrates and viral seeds. Further the FDA states that if raw materials were not sourced under the concepts of cGMP’s, proper documentation needs to be used to support the use of such raw materials in the CMC section of the submission (FDA, 2010). Another important aspect of GMP’s in relation to biologic manufacturing is process validation. Relating back to raw materials, there is a large concern for impurities associated with the final biologic product. The importance of process validation is that proper