At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes.
Change control is a systematic approach used in many industries to manage all changes made to a product or process. This is particularly important in the pharmaceutical industry, specifically as it applies to pharmaceutical manufacturing where the complexity of the tasks to be performed during manufacturing, packaging and analytical release testing require detailed documentation of each task. Any changes in how those tasks are performed or managed need to be illustrated and justified through a change control. In Part 1 of a two-part blog, we’ll look at the change control process in general, discuss some of the basic principles and review some of the changes in pharmaceutical development and manufacturing that require following a change control process. In Part 2, we will discuss the steps to implement such a process.