For those in the manufacturing business, we strive to meet those margins and do our best to be as efficient as possible. But, of course, we don’t have the intention to produce poor quality products, simply best value products. While intentions are always admirable, it’s still a regulated requirement to follow best practices and SOPs / Work instructions from official government bodies such as the FDA.
One of these regulations that particularly reference the food, lifescience and medical devices manufacturing business is Current Good Manufacturing Practices (cGMP). Again, this is a standard that helps ensure that the products being made are safe for consumption. As we continue to hear, even recently through the news, how contaminants are still finding their way into our food products, it’s more prudent than ever to adhere to these types of standards for, at the very least, safety and, at the most to ensure a proper trustworthy reputation.
Below we will take a deeper look into cGMP and how technology can help achieve the requirements.
What is cGMP all about?
cGMP covers all types of manufacturing, yet there’s a focus on it many times with pharmaceutical and food-based manufacturing due to it being consumed by people. It’s a set of best practices and regulations that the FDA has deemed necessary to cover everything from monitoring and control of manufacturing to the proper design of the process and facilities.
A typical example with pharmaceutical production is there should be clear metrics showing the strength and purity of the drug as well as what type of drug it is. The overall quality should also be easily discernable with the right system. All of this starts from the ground up by checking the quality and purity of all the raw compounds and ingredients needed to make the drug.
This level of scrutiny means having a clear SOP at every part of the manufacturing as a check system. It should also have an excellent recording system with every layer used and should easily produce (electronic) batch records where needed. The data collection should also be combined with consistent testing of all equipment and machinery and detect any production issues.
These consistent checks and balances find any deviations from production as well as keep an eye on if any contaminants have accidentally entered into the manufacturing process, either through faulty machinery or subpar products.
What are the key differences between GMP and cGMP?
On the surface, there are very few differences between GMP and cGMP. If you are GMP compliant, then your operation process and procedure are compliant for the time being. It’s the minimum necessary standard and may be seen as being more cost-effective than following cGMP standards. Yet don’t let that be a huge deciding factor, as being cGMP compliant is a much better strategy long term.
cGMP compliance is all about future-proofing the standards and working to comply with the latest regulations that are out there. It is an updated system that comes with significant investment and instalment of tech-heavy solutions. While these technological enhancements seem to be a high cost, they go beyond just ensuring cGMP compliance and will help the overall operational bottom line. This is because the entire manufacturing process tends to be streamlined and improved upon as a result of setting up cGMP compliance and regulation standards.
Your quality management system will just be that more robust and thus worthwhile when going for cGMP compliance.
What are the requirements of cGMP compliance?
The set of standards primarily follows 21 CFR rules and regulations. All of these have their own smaller requirements that, once fully complied with, become the cGMP compliance. This wide range of requirements effectively helps run a better manufacturing shop that covers the physical aspects of well-managed equipment, proper training, and the right record management and quality management systems.
Facilities and Manufacturing equipment– the area where the manufacturing is done, i.e. the facility, needs to be properly maintained for all activities that are being done. This means building a safe working environment for those that work there. In addition, the structural place itself needs to be in good form, as well as the cleanliness of the overall manufacturing facility. Then it’s down to the equipment that is used to make the drugs that need to be constantly checked for the right calibration, hygienic and have a proper maintenance schedule.
People involved in manufacturing – the staff itself needs to be properly trained in all aspects of the facility and the usage of their specific equipment. They need to have any additional training when responsibilities are expanded, or new equipment comes in. On top of that, they need to follow specific health and safety practices to remain hygienic and to keep the products as clean as possible.
Materials used – all materials used in the manufacturing process, especially when making the drugs, need to be stored properly and adhere to hygiene. The master formula for any of the drugs being made needs to be properly stored and easily accessible. The manufacturing must follow the master formula every time, which needs to be checked if you did so. No deviation is allowed ever, as that could inherently change the product.
A Proper Procedure – All this needs to follow a uniform SOP with all aspects of the manufacturing. From maintenance and cleaning of the equipment to packaging and distributing the drugs to vendors and pharmacies, these must be well documented, and everyone needs to be fully trained on existing and updated procedures. All processes and procedures need to be reviewed regularly to ensure that anything relevant or new in the manufacturing, science, or quality management industries is incorporated.
In the end, the processes and procedures should easily be reproducible on a daily basis, without the need for anything specialized to help support that operation. They also need to be reliable and ensure a consistent result and output as well, meaning there’s minimal to no deviation in the production quality, and the process flow doesn’t need to be consistently changed or adapted upon.
This is to ensure that the products produced on day 1 are the same as those made years later due to the quality management implemented and adhering to the built-in well-documented process.
To maintain this type of compliance, is to remain vigilant of it. It doesn’t stop with simply installing a system in place. Make sure some key people have the right ownership of every process out there. Also, for security purposes, only a few people should have the ability to modify or update records after the fact. That should be coupled with general data integrity standard practices such as ALCOA or ALCOA+. This means having a complete set of data, with a traceable and auditable history as well.
Why software is a huge component in cGMP
To better help with all the compliance, testing and record management, working with the right type of technological solution will be a must to achieve cGMP. In addition, you want your systems to be dynamic and grow with the ever-shifting changes throughout the landscape.
One of the best advised places to start with technology is the core component of cGMP compliance: product transparency and traceability. Having the right electronic history to quickly see the source of each raw material used to manufacture the drug helps build an audit trail in case of a mishap or accident.
Then it’s all about ensuring that the SOP is properly absorbed by staff through interactive training systems and tracking those pieces of training through built-in e-learning systems. It can help through visual learning and practice that often gets lost in more traditional paper-based training. There are also ways to track the work that is being done, either during a training session or a regular day, to see how it complies with the SOP and actual process for that specific step.
A digital SOP also helps to show exactly how to do something with the combination of visuals, video and text, allowing for easier absorption and a centralized digital location to push updates when needed. This also helps when something goes wrong and those on the floor need to troubleshoot it immediately. It’s akin to a digital mapping system that can easily see if the issue is at the current machine or process or coming from somewhere else.
This type of complete digital integration into the overall process also helps when it comes to data gathering. That means complying with electronic batch records and digital records management that comes from 21 CFR part 11 as well. Getting each data point not only helps with compliance but also helps the organization as a whole to help make data-driven decisions.
What a quality management system can look like
Now that we know how beneficial it can be to get a quality management system up and running, not just to comply with cGMP regulations but also with business operations, it’s all about finding the right type of tool that can help support the business beyond compliance.
That’s where Azumuta comes in. It’s built to help achieve this compliance level and fully digitize every aspect of the manufacturing floor. It’s made with a holistic mindset to cover everything from digital work instructions to audits to training and competency checks. It also has been built to be able to connect to third-party systems easily to integrate completely with the system architecture.