As Dr. Simon mentioned, GMP guidelines are written generally and ambiguously, so how often are companies looking to improve/update their GMP requirements? For those in the work field can you give an example of when their company improved an aspect of their GMP processes?
As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas of inspection or in other words inspection techniques have become more strict and controlled. All aspects of manufacturing at checked to ensure that the product meets/exceeds all company standards. One particular instance is that we are thinking of introducing smart height gauges that will replace that standard calibrated ruler to accurately measure elevated height of our product, while in manufacturing.
GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply with these regulations. Although I do not know an exact number to how often companies should improve/update their GMP requirements, I believe that systems, processes, and technologies must be kept up-to-date to comply with the latest regulations. Companies and employees are responsible for ensuring continual improvement in technologies, such as up-to-date records to show that procedures have been followed, traceable batches and distribution of products, validation of changes to procedures and processes, etc. Overall, a system or process that worked a decade ago may not be adequate to comply with today’s standards.
Thank you very much for your input on this question. I would agree that when a company's technologies are updated the GMPs must then be kept up to date. When these updates in technology occur, they can drastically change the way that a process or procedure is run, thus the GMP must match that new process. However I do not have much experience in this area so I am unaware if there is a set amount of time they have to update their GMP or if it is a process that gets updated with the new technologies added.
From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions were unclear and created confusion. I have also seen GMP standards updated for technology updates, or building updates, such as a wash room being moved, and as a result, different tools were needed to fit the new hose requirements, etc. One company that I worked for, we would review GMP SOP’s every 2 years to determine if any needed new revisions or changes to either keep up with updates or to clarify them.
I think technology can make it both easier and harder to comply with GMP regulation and they key is to update along side of regulation. It is important to review the guidelines and have everything understood before improving processing that require new equipment or location changes because there are things that can be done to prevent correction.
Depending on how established the company is, GMPs may be constantly under appraisal in order to refine them. The changes can range from a minor difference in recording something to entirely modifying the system in place for the company's QSR. Where I work, the GMPs are very well established and are rarely changed. If there is a change in the GMP, there is an extensive approval process and meetings to ensure that everyone in upper management is in agreement over the change. There are changes that can be due to technology updates as aforementioned above, but it is rarely something that would be a radical change to the system as a whole.
The GMP, or Good Manufacturing Practice, gives a general outline of the requirements set for the company. This includes the methods, facilities, and controls within the project. The methods that are done to complete the project should meet with these set requirements. It would make sense for the company to update the GMP accordingly with the changing requirements. This way the products will follow the latest protocols necessary. If the company does not keep up with the latest updates, they do not ensure that the product consists of the best ideas. Sometimes a small change may not make a big difference in the GMP. However, when there are major modifications made within the regulations, the GMP must be updated accordingly.
My company performs a yearly review of our manufacturing practices. However, I did find a publication by the NSF about changing your quality culture and improving GMP behaviors. It steps the reader through identifying what needs to be changed, what works and doesn’t work, and what motivates people. Additionally, it describes a unique five-step behavioral change process. The steps are:
STEP ONE: Identify the specific behavior you want to change
STEP TWO: Understand what drives the old
STEP THREE: Get people motivated
STEP FOUR: Create the ability for the new behavior
STEP FIVE: Make the new behavior a habit
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances errors or problems from a medical device for example. GMP is also sometimes referred to as "cGMP". the "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent errors or failure in a medical device for example. Because of GMP guidelines are not prescriptive instructions on how to manufacture products, so GMP should be updated according to FDA Quality Regulations.
GMP represent good manufacturing practices, all medical companies have a list of regulations for there standards for good manufacturing practices. The company I work for has not updated the GMP quality system document for a while. The reason is because the current GMP document clearly states the guidelines for the type of manufacturing practices that they want the company to have. We are all trained per our enrollment as a new employee to these regulations and they are in effect every single workday. Therefore, they tend to not update the document unless they need clarification on a specific regulation.
Good manufacturing practices (GPM) are quality regulations that medical/pharmaceutical companies follow in order to reduce the risk when producing medical devices. The company I currently work for has not updated there GMP guidelines in the last 6 years, but when they find flows or risks within the GPMs the make sure to complete/update documentation in order to reduce any risks.
Something that my company did and is currently doing to improve GMP is overhauling a remediation that looks over every procedure and important documents used in the management system and going over it with a fine tooth comb. Doing so is a preventative action in knowing that all documents are procedures are accurate, up to date and follow proper procedure. Another action that my company took is making sure each employee rereads the more important training docs and reads the improved documents. Having a refresher can also help to maintain good GMP.