To ensure that medicinal products and devices are always fit for their intended purpose one of the key tools in the GMP toolbox is Change Control. Some people see Change Control as being a slow and unwieldy process when attempting to modify and improve equipment, systems, processes, packaging, artwork or other related improvements.
Yet Change Control is required to protect public health and the patient. The regulatory authorities take Change Control very seriously when auditing healthcare manufacturers. Relatively little time needs to be spent reviewing FDA warning letters to see such comments as ‘Your Change Control process was deficient: For example changes were made to the equipment process control software without a formal change being raised and processed, no risk assessment made, and no consideration of consequential effects on the programme and function of the equipment. The change was implemented without testing and QA approval.’
The need for understanding Change Control and its application is a must for all people working in a GMP manufacturing plant, as well as those working within other GxP related roles.
A very important part of Change Control is applying the Risk Assessment process to determine potential risks associated with the change. Risk Assessment is another process which the EU, FDA and other global regulators are requiring organisations to use through such ICH Q9 and EU Annex 20 guidance documents.
Industrial Technology Systems Ltd (ITS) offers the following Change Control Training Courses, including related Risk Assessment, with more to come shortly, to help companies, big or small:
-
Understanding GMP Change Control Training for Engineering and IT Training Course is a GMP related 1/2 day training course for QA, QC, IT, Engineering and other GxP staff who need to understand what Change Control is and why is so important when working with equipment, systems and processes. Suppliers to the industry may also find this course beneficial.
-
Applying GMP Change Control and Risk Assessment for Equipment and IT Applications Training Course is a one day course comprising of the course listed above for the first half of the course. The following second half day, investigates three different methods of applying risk assessment tools as a part of the Change Control process. Suitable again for QA, QC, IT, Engineering and other GxP staff who would need to understand what Change Control and associated Risk Assessment is and why is so important when working with equipment, systems and processes. Suppliers to the industry may also find this course beneficial.