Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing…
The following is an excerpt taken from The Windshire Group’s webcast “Implementing a Change Control Quality System Successfully Expert Panel Discussion – Live FREE Webcast”.
Daniel DeLucy: Any time that we have a change in the environment, whether it’s in the laboratory or the manufacturing area, facilities, utilities, or design, you need the associated documentation and SOPs to support your change. A lot of time changes are extremely simple, It could be just maybe an adjustment, to a PSI gage or something like that. Maybe you’re just fixing a typographical error on the documents. Maybe you’re just replacing a part. Those are very minor changes. Sometimes it could also be a change because you had a deviation and you need to fix that, maybe it’s a deviation from approved regulatory filing or written procedure.
Change can be a number of things. It could be temporary or permanent. You can institute a temporary change if you’re doing some construction in your area in order to reroute traffic and gowning flows. It could be permanent with constructing a brand new facility or doing something else. It can also be routine or emergency, being in industry for quite some time I’ve dealt with many emergency change controls that sometimes I question whether or not they really were an emergency but there’s always that interaction between manufacturing, regulatory and quality and discussing whether or not your change can just be implemented as a routine change or if it really needs to get on the docket as an emergency change. It could be serious enough to shut down production or a change that would impact the safety of your employees as well. Change is always happening in the environments we work in, very dynamic environments, so having a change control system is extremely critical especially in our highly regulated industry.
When you have inappropriate or uncontrolled changes people could just go in and maybe make unapproved changes to equipment or laboratory assays or just even your traffic or your personal protective equipment. That could certainly affect your safety, the patient’s safety, your products such as their reliability and they could ultimately impact the public health and safety of our patients.
So those are a few points to consider just while we’re talking about change control and how important it is and really is quite a cornerstone of the quality system, when you think about it with regard to the CAPA deviation systems in general. So change control is something that is sometimes misunderstood but hopefully this webinar can answer some of your questions that you may have about change control.
For a free download of the entire webcast recording – click here
To read the complete free transcription – click here
Dig Deeper – For our in-depth on-demand Change Control one-hour webcast – click here