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Validating a GMP Process

Some of the oldest guidelines on GMP cleaning from 1963 state that 'Equipment shall be maintained in a clean and orderly manner' Over the years as regulation has changed, the FDA has remained constant on this, it is the pillar of any cleaning program in effect today throughout GMP manufacturing sites.


In 1988, a case that greatly raised the awareness of this was when cross contamination from inadequate cleaning procedures of a recalled finished drug product, Cholestyramine Resin USP. The product had been contaminated with low levels of intermediates and degradants from the production of agricultural pesticides. The items in question were the drums that were used for solvent recovery that were not properly tested and gave rise to this contamination. The chain reaction that was caused with this, as other finishing locations suffered the same contamination in their fluid bed dryers where no pesticides were manufactured raised the awareness of the need to validate a process in its entirety.


Cleaning and validation programs are required by the FDA and other foreign agencies to be adequate throughout the life of the process, not only to include what is considered high risk, but every step of the process. If solvents are being reused such as with the 1988 case, the drums that hold that solvent must be tested to ensure there is no cross contamination. When contract manufactures switch processes, the cleaning validation program must have the highest level of detail to identify any shortfalls in the SOPs.


Hiring a firm that has the understanding of how to validate a cleaning process can be paramount in the success of a manufacturer. Having personnel who understand the steps required, the SOPs the chemistry required as well as the knowledge of validation of a GMP process is truly a strategic partner in a process. Nx2 personnel is trained on understanding processes and validation of GMP cleaning programs.


Want to find out how your site can benefit from a cleaning team that understands the importance of a validated cleaning process? Contact Nx2 today to set up a site visit and review of SOPs and see how we can help your firm be more effective.

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