For pharmaceutical manufacturers, strict adherence to the US FDA’s Current Good Manufacturing Practices (cGMP) is paramount to ensure the safety of the public (and the long-term success of your company).
Consistently producing high-quality products is a primary focus area for many businesses. However, missing the mark with quality can have catastrophic consequences in some sectors.
Manufacturers of medicinal products need to use the right tools to keep regulatory requirements in check and take the uncertainty out of managing cGMP requirements.
Here’s how a robust cGMP management system can help you stay on top of your product manufacturing.
How cGMP Fit in the Pharmaceutical Industry
In the US, the US Food and Drug Administration (FDA) highly regulates the pharmaceutical industry. The FDA’s Federal Food, Drug, and Cosmetic Act places Current Good Manufacturing Practices (cGMP) at the center of this regulatory environment.
By the way, pharmaceutical companies outside of the US also have regulations to follow. For example, in Canada, companies adhere to its own set of good manufacturing practices for drug products (GUI-0001).
These approved practices ensure that companies manufacture pharmaceutical products, dietary supplements, and medical devices to high standards every time.
“The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use and that it has the ingredients and strength it claims to have.”
FDA
In fact, pharmaceutical companies can only release new drugs to the market after a careful review of their compliance with cGMPs.
GMP standards cover legislation around everything from:
- raw materials to labeling,
- staff capabilities,
- equipment maintenance,
- standard operating procedures (SOPs),
- reliable testing laboratories,
- quality assurance, and
- reliable validation of products.
This means that for pharmaceutical businesses to execute successful product launches and continue to post strong revenue growth, current good manufacturing practices must be at the heart of their business operations.
cGMP Standards and How to Manage Them
The benefits of a consistent, procedure-driven manufacturing environment extend to all areas of your business. In other words, best-practice manufacturing ticks off far more boxes than just compliance.
From the economic benefits of consistent batch manufacturing to the positive branding that stems from adopting best-practice approaches before competitors catch on, understanding the laws and being all-in on cGMP makes perfect business sense. And is the law.
However, effectively managing a cGMP ecosystem takes time and effort. Keeping the following focus areas on your radar will help your business successfully navigate cGMP compliance.
With a CMMS, requirements and cGMP standards become easier to integrate into daily workflows and quality control measures.
Focus on Continuous Improvement
Current is the crucial word when it comes to good manufacturing practice regulations. So much so, in fact, that the FDA specifically added the “c” to GMP to encourage all pharmaceutical businesses to take the initiative and stay up-to-date with innovations and developments in the industry.
“[Companies should] use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been ‘top-of-the-line’ to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.”
FDA
By specifying that standards need to be current, the FDA suggests that drug product manufacturers cannot adopt a ‘“set-and-forget” management model.
Instead, businesses need to work to improve pharmaceutical quality constantly. Awareness of good manufacturing practices is vital, even when specific FDA directives have yet to become law.
Not surprisingly, companies that prioritize continuous improvement are a step ahead. Rather than waiting to make one large improvement, we recommend implementing established approaches focusing on small, regular, iterative improvements.
If you are familiar with lean manufacturing approaches, you will likely be comfortable with the cyclical nature of quality improvement. That is, constantly review what’s working and what’s not.
Implementing new procedures and practices on a small regular basis allows them to be more easily absorbed into the regular flow of work. Thus, they will cause less disruption to your drug manufacturing process.
Move Your Paper Trail Online
Without diligent recordkeeping, adhering to cGMP requirements can quickly become overwhelming.
Traceability requirements are laid out in FDA 21 CFR Part 11. Yet, many manufacturing facilities need help to adequately manage the piles of checklists, guidance documents, manuals, and procedures. In addition, with the FDA requiring companies to keep records electronically, we recommend putting a robust digital system in place. A CMMS (Computerized Maintenance Management System) can alleviate much of the administrative workload, offering an easy-to-use recordkeeping solution. MaintainX is one such system, but no matter which platform you use, your workforce needs it to be simple and easy to access.
Generally, your standard operating procedures (SOPs) and preventive maintenance work orders should ensure equipment is well maintained and in good condition and workers carry out periodic inspections. In addition, managers need to fully document any events that affect manufacturing processes.
Likewise, preventive maintenance needs to be top of mind for maintenance crews, as does hygiene and sanitation when working around biological products.
If Quality Drops, Look Deeper
When deviations from acceptable product quality occur, root cause analysis can help your team discover why.
Robust quality management systems are one thing, but if quality control checks reveal systems and procedures are failing, your team can use a range of techniques to dig into the real reason quality standards aren’t being adhered to.
Root cause analysis tools like Failure Mode and Effect Analysis (FMEA), fishbone diagrams, and Fault Tree Analysis can help teams work together to solve any issues, minimizing any dips in quality.
Get Your Team on Board with MaintainX
A united effort is required for quality to become a core driver within your organization.
Consider integrating a CMMS to ensure your business operates efficiently–even within a highly regulated environment. A robust CMMS like MaintainX can help streamline your cGMP by:
- Standardizing your manufacturing and maintenance processes
- Guiding workers through preventive maintenance
- Automating inspection data collection
- Analyzing collected data from cGMP
- Tracking product quality and consistency over time
- Communicating regulatory requirements
FAQs
Caroline Eisner
Caroline Eisner is a writer and editor with experience across the profit and nonprofit sectors, government, education, and financial organizations. She has held leadership positions in K16 institutions and has led large-scale digital projects, interactive websites, and a business writing consultancy.
