Change Control- A Critical Issue in the Single Use and Pharmaceutical Process Industry

April 29, 2015

At a recent panel discussion of bioprocessing industry experts regarding the evaluation of stainless vs single use process components, one panelist was asked an interesting question- when evaluating a single use validation package, what piece of information do you consider to be the most critical? The panelist’s answer may surprise you. While many in the audience may have guessed USP Class VI testing or leachables and extractables studies, this panelist (a category engineering manager for a major pharma company), responded that vendor change control procedures were most important to her when evaluating a new product for their process. This blog will take a look at the why documentation of change is important and what events can trigger a change

To begin, what is a change and why does control of change matter? The pharmaceutical process industry is one of the most tightly regulated industries in the world. And for good reason- patient’s lives may ultimately depend on the quality of decisions made by the people who are responsible for the quality of products and the processes used to manufacture them. A “change” may be a simple adjustment to accommodate a customer specification, an updated document, a part replacement, or other production change. It may result from a deviation from an SOP or work instruction. A change may be temporary or permanent, routine or emergency.

Because change is an inevitable event in any manufacturing process, control is critical. Changing of a process is complex and communication of the change to key stakeholders can be equally challenging. For that reason, it is absolutely essential that clearly defined systems exist that manage how changes are implemented and how they are communicated to stakeholders.

So what are some common events that may result in the need for a manufacturer to send a change notification to an end user, you may ask? Those may range from benign to the extreme- product discontinuation or recall. A few examples of changes that a manufacturer is generally expect to notify a customer prior to implementing include changes in labels or packaging of a material, change of company name, change in shelf life, or changes concerning storage conditions.
While a simple “heads up” may work for some changes, others require more advanced notification- usually a minimum of 6 months. Examples of these sorts of changes include the change of a critical subcontractor, new edition of an analytical specification or product test method, or change regarding animal origin of a raw material. Other changes, such as changes in test methods, elimination of a test method, change in manufacturing site, change in raw materials, may necessitate notification of stakeholder of 9 months or more in advance of a change.

For a distributor like Holland, it is equally important that we have systems in place to handle changes the companies we represent make. With hundreds of active open accounts, it’s critical that we act have clearly outlined and detailed procedures for handling a change made by a manufacturer and getting that information to our customer’s so they can take appropriate action .

To conclude, at Holland, we understand that manufacturers are being continually pushed to develop innovative, high-quality products at lower costs. Whether it’s to stay competitive or to enter new markets, manufacturers need to make changes to meet customer demands. We understand that having a robust quality system is essential to both our success and our clients. If you have any specific questions regarding our quality systems or change control guidelines, contact a Holland Sales Engineer today.