Did you know that there are regulatory standards that apply to all industries within manufacturing, not just controlled substances?
Ensuring your company is up to date with current Good Manufacturing Practices (cGMP) is an essential part of quality management in manufacturing.
cGMP exist to guarantee proper handling, processing, and packaging of medical and biological products for the health and safety of the consumer.
Let’s go over the purpose of these standards, who must adhere to them, and also how to implement them within your own facility.
Who Must Comply With Current Good Manufacturing Practices (cGMP)?
Particular health industries like pharmaceuticals and medical devices have to be well-versed in current good manufacturing practices. This responsibility is because the products produced by these industries have direct health effects that can be life-saving or fatal.
What you may not realize is that cGMP apply to manufacturers outside of the pharmaceutical industry as well. According to guidelines moderated by the FDA, this includes manufacturers as well as processors and packagers.
Manufacturers, processors, and packagers exist in a variety of industries, like electronics, consumer goods, aerospace, automotive, food and beverage, and rail, for some examples.
This means that even if you don’t directly make the product yourself, you still could be liable for lack of current Good Manufacturing Practices if you are merely shipping these products at some point along the supply chain.
This is critical for proper handling and avoiding contamination, guaranteeing that a quality and effective product is delivered to the customer.
Example #1: cGMP for COVID Vaccines
An example of this is COVID vaccines: after being manufactured, they are distributed to pharmacies, hospitals, and clinics. Even though these places don’t directly manufacture the vaccines on premises, they are legally responsible for keeping vaccines properly stored at the right temperature and in a sterile environment.
Example #2: cGMP for Food and Beverage
Another example is packaging consumables for grocery stores using best before dates. A facility that packages food items like cans of soup or cookies or dairy products must properly label these items with their expected expirations to avoid customers getting sick.
A final example is processing materials for electronic devices. Processing plants must conduct routine testing of final products to make sure hazardous elements are not present, such as lead or excessive radiation in smartphones. This is also why certain plastic products are always clearly labeled as “BPA-free”.
How to Introduce cGMP Within Your Manufacturing Facility
Most of the requirements of current Good Manufacturing Practices are up to the individual manufacturer to decide how to implement their own processes and procedures.
Think of current Good Manufacturing Practices as another form of traceability. Here are some areas which require you to keep cGMP compliance.
Records of product orders, including accurate information about the materials and components, must be kept in a secure location and accessible to floor managers when needed for reference.
This enhances traceability within your organization – an up-to-date and accessible record base allows you to respond quickly to any discrepancies in production, which means minimal waste and less downtime.
The facilities involved in production and distribution must be clean and organized to prevent potential contamination.
This is especially important for health products and consumables like food and beverages. Not only will products be received more highly when produced in a clean room, but they also will be more effective, last longer, and spoil less frequently.
Especially for controlled substances and active ingredients, manufacturers must ensure high quality to minimize the potential for a defective product.
If your product is expired, defective, or of low quality, you could be legally responsible for deceiving customers or even harming them. At the very least, you will destroy any trusting customer relationships that have helped you succeed so far.
Production processes have to be understandable and relevant to the job order, so that at any point along the manufacturing process can be critically and quantitatively assessed.
For example, a shop floor lead may not have specialized skills in welding, but they must know which procedures need to be followed for proper welding best practices, both for safety and for quality assurance. They must also be able to describe the process flow to someone unfamiliar with that facility's standards, like an auditing inspector.
Workers who perform skilled actions must be properly trained and hold the required certifications for their specialized jobs.
If active ingredients are involved in your product, for example, you must employ appropriately certified scientists in that respective field to confirm quality work.
Not only must machinery be properly cleaned and maintained for reliable use, but it also must be upgraded when improvements are available.
This doesn’t mean that every machine on your production line needs to be the latest version of machinery released. What it DOES mean is that your equipment must be maintained such that it can reliably and safely produce items at scale without significant adverse effects or failures.
When defective products are found, there must be a set of standardized procedures for disposing of the defective product and also for addressing the root cause of errors.
If the product being assessed contains active ingredients or biohazardous materials, for example, you must have SOPs in place for proper and safe disposal, not just throwing things in a dumpster when chemicals could leach or individuals could unknowingly interact with dangerous parts.
This list should give you a sample of the variety of areas throughout production where cGMP apply. These standards are in place to guarantee accurate information and provide life-saving care. This is why current good manufacturing practices are crucial for delivering quality reliable products.
Best Ways to Stay cGMP Compliant
There are many ways of configuring your facility to keep compliant with current good manufacturing practices. Ideally, the purpose is to remain current, so set up your production cycles for iterative reporting and projected maintenance. This will help fuel continuous improvement so that you don’t need to perform full audits from scratch every few years.
When considering how your plant measures up, think of the following 3 resource types to stay up to date and within regulations.
1. Use a Manufacturing Execution System (MES)
One of the best ways to have control and visibility of your manufacturing processes is to set up an MES, or manufacturing execution system. This kind of software allows you to have all the necessary information at your fingertips.
An MES or other software platform (like an MRP or material requirements planning) gives you both in-depth information and also an overview of the manufacturing ecosystem as a whole. Using this software, you can connect serial numbers to workstations, for example, in order to ensure traceability.
A digital platform such as work instruction software can also integrate with inventory, timesheets, and many more processes, providing practical hands-on direction to those working the shop floor.
Pro Tip : If you’re having doubts about what kind of enterprise software is the best for your operations, check out our FAQ on how to choose an MES for clear answers to the most common questions manufacturers ask about choosing a software solution.
2. Audit Documentation and SOPs
It’s not all software – an important step to establishing current Good Manufacturing Processes in your organization is to audit all physical and electronic documentation. This also includes auditing your standard operating procedures (SOPs).
A key part of cGMP is the c for “current”, meaning up-to-date. Your old SOPs may have worked fine in the past, but with the progression of manufacturing technology such as IoT devices, some troubleshooting or custom integration may be necessary in order to make sure it all runs smoothly.
For example, what used to be a paper or manual process like clocking in to a shift could be optimized with employee barcodes and reference numbers. The old “clocking in” routine may have worked okay, but there is far more traceability and accuracy when using a connected digital tool for SOPs.
3. Collect Data in Real-Time
Finally, a helpful way to see if your efforts at traceability are effective is to collect production data in real-time. But where do you find this data?
There are so many ways to collect data (and so many different types of data), but you should at least double-check that at least some data is gathered via your MES or ERP.
Once it is collected, you still must communicate that data by applying its insights to the work processes that occur at your facility.
For example, it’s not enough to know that somewhere in your system there’s a database of defect logs. In order to remain cGMP compliant you must also be able to access that database quickly and interpret actionable information for better manufacturing.
A key aspect of collecting data is making sure that it is “in real time”, also known as Just-In-Time. Not only is this more accurate than legacy data, it also allows managers to immediately adjust and correct processes when needed so that fewer defects occur and less materials are wasted.
Keeping Good Manufacturing Practices Current
Current Good Manufacturing Practices are good for everyone along the supply chain from natural resource processors to consumers of final products.
By adhering to the cGMP set by the FDA, you can guarantee that your products are safe and of high quality. In turn, consumers feel safer subscribing to your products and the trust between you and your customer base strengthens.