Standard Compliance Practices For Technical Cleaning in GMP Manufacturing Facilities
In the world of pharmaceutical manufacturing, precision is paramount.
Every manufacturing process step must be stringently documented and compliant to ensure goals are achieved.
And it makes sense. With the health and safety of patients and consumers in mind, strict compliance practices must be followed to ensure the highest quality products. Years of research and rigorous testing through strict clinical trials are prerequisites for a new drug entering the market.
But how do companies control and maintain the quality of their medical products once they’ve been produced? How do you ensure your manufacturing environment is free from contaminants or any other contamination-causing agent?
The answer lies in cGMP (Current Good Manufacturing Practice) for cleaning, sanitation, and maintenance of equipment and facilities. Achieving cGMP standards is crucial to ensuring a product’s quality and safety.
Technical cleaning plays an essential role in compliance with good manufacturing practices, and it is essential to understand the best practices and associated challenges. But as technology advances and requirements and standards shift, it can be challenging to understand what constitutes a good standard of technical cleaning in a good manufacturing practice manufacturing facility.
To help make things easier, we’ve put together some simple best practices to keep any facility (and the consumers it serves) running smoothly.
WHAT IS CGMP? A BRIEF OVERVIEW AND CONSIDERATIONS
At their core, common good manufacturing practices are a set of rules to help ensure that products produced in a manufacturing facility are safe, consistent, and meet the standards of quality set by regulatory bodies.
Good manufacturing practices are a set of regulations enforced by the FDA to ensure that pharmaceutical products are consistently manufactured to a high standard. They were first enacted in 1963 by Congress following the near-sale of thalidomide in the US. Initially developed as a sedative, the German-made drug was found to cause congenital disabilities in children.
For pharmaceutical manufacturing in the US, the FDA 21 CFR parts 210 & 211 are the foundation for the minimum requirements for the guidelines. They cover all aspects of the manufacturing process, including design, monitoring, and cleaning, to ensure that products are of the highest quality, purity, and strength.
A lot of attention is paid to the front end of the process — the design, development, and production of products and their ingredients. But paying attention to the back end is equally important, which is where technical cleaning comes into play.
WHY CGMPS ARE IMPORTANT FOR PHARMACEUTICAL COMPANIES
So, now that you know what current good manufacturing practices are, why are they so crucial for manufacturing facilities?
Here are a few of the reasons every company should craft a plan of action for technical cleaning that adheres to current good manufacturing practices:
SAVES COMPANIES MONEY
No one wants the dreaded FDA 483 letter to land on their desk.
Keeping production up and running is the only way to stay profitable and competitive in the market. Regular technical cleaning is a great way to prevent production downtime due to equipment malfunctions, increasing efficiency and saving the company money in the long run.
Additionally, although monetary fines aren’t the norm, they can happen. But the risk of downtime on the production line is an even more likely (and expensive) outcome of not adhering to good manufacturing practices.
cGMP compliance is all about protecting the consumers who will be taking these drugs, and technical cleaning helps keep contaminants out of the product. Technical cleaning reduces risks of recalls and contamination of products, which could lead to devastating consequences if the drug does not meet regulations.
Keeping your clean-rooms clean and free from any contamination-causing agents is the first step in maintaining high standards.
PRODUCE HIGH-QUALITY DRUGS
With the FDA looming, all aspects of the production process must meet or exceed quality standards. Technical cleaning is no exception; companies must ensure that their clean rooms and equipment are regularly maintained to maximize drug safety and efficacy.
The FDA routinely tests for “adulterated” and “misbranded” drugs, so technical cleaning is one way to ensure that your products are safe from both.
Adhering to current good manufacturing practices with technical cleaning will improve product consistency, ensuring that patients receive the highest quality drugs — and your company can maintain crucial revenue flow.
A recall on a product can damage brand equity and instill fear in customers, leading to a loss of business.
Technical cleaning is an effective way to prevent recalls. Cleaning and maintaining your equipment helps you identify problems before they become major and can mitigate the risk of contaminated drugs or products entering the market.
WHAT MAKES CLEANING GMP MANUFACTURING FACILITIES UNIQUE?
Unfortunately, properly cleaning a manufacturing facility isn’t as simple as scrubbing a few surfaces.
Good manufacturing practices require a planned and documented approach to cleaning and eliminating contaminants. This includes controlling the environment, staffing, process design, and facility layout.
Cleanrooms must be designed to reduce the risk of contamination and be well-ventilated, with air quality monitored continuously and cleaned regularly. Additionally, materials used in production must be carefully selected and tested to ensure they pose no contamination risk.
This also means you need a plan to mitigate a breach of your cleanroom — how will you eliminate unwanted particles in the zone?
Additionally, it’s important to have microbiological testing of the surfaces, air samples, and other environmental factors as part of a comprehensive GMP program.
When you design a consumer goods manufacturing facility or even a restaurant, it’s not critical to consider the risks of contamination with such strictness. The need for pre-planning sets technical cleaning apart from the average facility maintenance plan.
The facility’s design informs the processes for cleaning, and the processes control the environment by which materials are moved through the facility.
The complex nature of GMP-compliant technical cleaning makes it essential for any manufacturing facility to partner with an experienced and knowledgeable service provider who can develop a customized plan that meets all regulatory requirements. When you work with an expert, you can be sure your facility complies with current good manufacturing practices, and your products are safe for consumption.
THE DIFFERENCE BETWEEN CLEANING AND SANITATION IN GMP
Before diving into our best practices for a well-designed good manufacturing practice SOP, we must discuss the difference between cleaning and sanitation. Understanding the terminology is essential for creating a successful plan.
Cleaning is the process of removing visible dirt, dust, and other contaminants from a surface. It does not guarantee the elimination of bacteria or microorganisms, but it does reduce their presence enough to prevent contamination from spreading further.
Sanitation goes beyond cleaning and eliminating living bacteria, microorganisms, or viruses from a surface. This is typically done through disinfectants, heat, or even manual scrubbing.
While both cleaning and sanitation are essential processes in GMP-compliant technical cleaning, sanitation is more critical for ensuring drug safety. Therefore, it must be included in your SOPs to ensure that your facility is always compliant with good manufacturing practices.
THE BEST PRACTICES FOR TECHNICAL CLEANING
Creating a successful technical cleaning SOP requires careful consideration of all the following best practices. How you will keep your facility in good standing is a question that should be answered as early as possible in your go-to-market plan.
The earlier you consider the cleaning plan that works for your facility and products, the better. Investing in a professional to develop and manage a comprehensive SOP will help ensure you meet all regulatory requirements and protect your business from liability.
1 – UNDERSTAND FEDERAL REGULATIONS
Knowing the rules is the first step to succeeding in the good manufacturing practices space. Familiarizing yourself with FDA regulations, CGMPs, and other relevant standards is essential for keeping your facility compliant.
This step can be daunting for anyone unfamiliar with technical cleaning. Fortunately, there are consultants and service providers who can help guide you through the regulations, ensuring you meet all requirements for your products’ success.
2 – CREATE A SOLID PLAN
Of course, you need a plan. But the level of detail and specificity that goes into technical cleaning is often overlooked. This can be a huge mistake, as it could lead to your facility not meeting all the requirements for good manufacturing practices.
Your plan should include every aspect of how you will clean the facility, including cleaning and sanitation processes, the products you will use, the steps involved, and the personnel responsible for each task.
Additionally, you and your team should game out the worst-case scenarios and determine how you will respond if something goes wrong. This could be anything from an equipment malfunction to a process misunderstanding. Having contingencies built into your SOP can help you avoid major issues and ensure good manufacturing practice compliance.
3 – CLEANING PROCESSES SHOULD BE WELL-DOCUMENTED
Having a plan is one thing; it’s quite another to have it documented. Proper documentation is key to satisfying the FDA on routine (or unannounced) inspections.
Your standard compliance practices should be detailed enough to provide a complete picture of your facility’s operations. Yet they should also be easy enough to understand for anyone involved in cleaning or production.
Moreover, it’s not enough to catalog what will be done.
Documenting the results and actions taken throughout the process is essential to prove that your team follows good manufacturing processes.
In fact, the FDA recently revealed that of all the reasons for issuing a From 432 warning letter, “procedures not in writing/fully followed and absence of written procedures” were at the top of the list.
4 – UNDERSTAND THE RISKS
Your plan is only sound if you know all of the risks associated with non-compliance. Pursue training for your staff and ensure everyone understands the consequences of not adhering to good manufacturing practices.
Investigate any potential sources of environmental contamination or cross-contact and any safety risks associated with chemical cleaning agents or physical scrubbing devices.
Ensure that your staff is knowledgeable about the equipment they use to maintain it properly and identify any potential issues before they become a problem.
5 – KNOW WHEN TO CLEAN IN PLACE (CIP) OR CLEAN OUT OF PLACE (COP)
In most cases, it’s more efficient to clean process equipment in place. This shorter, less labor-intensive option reduces the risk of contamination.
However, if your machinery or parts require a deeper cleaning –- such as residue removal from hard-to-reach areas — you may need to use the Clean Out of Place (COP) method. This involves taking apart equipment and washing it off-site, which can mean downtime for production.
If your facility requires COP, create a schedule that satisfies your business and regulations.
6 – CHOOSE THE RIGHT CLEANING METHOD
For most jobs, high-temperature cleaning is the best solution. However, the time it takes and the temperature needed are specific to the types of equipment and types of contaminants present.
Some facilities and kinds of equipment can implement manual cleaning with chemicals, brushes, and sponges. This is less expensive but slow compared to high-temperature cleaning.
High-pressure steam is another option, but it has drawbacks: It can damage equipment if done incorrectly, and more time may be needed to do a thorough job.
Working with an expert familiar with your use case is best to ensure you follow good manufacturing practices and not put your facility at risk.
7 – UNDERSTAND THE CONCEPT OF DWELL TIME
Every cleaning job will require time before the equipment can be used again. The length of this period, also known as “dwell time,” varies depending on the job and the environment.
Your good manufacturing practice SOP must account for how long it will take to prepare a machine for production after cleaning and disinfection. This includes rinsing, sanitizing, and drying.
Failure to leave enough dwell time can mean contamination; conversely, too much downtime leads to decreased production efficiency. Working with an expert to identify the ideal cleaning procedure for your equipment and the types of contaminants present is essential.
8 – DON’T SKIP THE RINSE STEP
Especially for cleaning procedures that implement chemicals, a rinse step is essential.
This removes any residue that can cause a reaction with other materials or ingredients and ensures your equipment is safe and clean for the next production stage.
The choice of rinse will depend on how delicate the equipment is, so consult an expert in this area if you’re unsure.
9 – CLEANING VALIDATION IS CRUCIAL
Finally, you’ll need to verify that your cleaning processes work correctly.
Validation should be done regularly, including checks, inspections, and tests to ensure proper equipment performance. This is necessary for any changes in material, equipment design, or process conditions.
Proper validation also requires documenting all activities related to the maintenance and sanitation of process equipment. This helps you ensure compliance and reduce the risk of a recall or contamination due to improper maintenance.
By following these tips, your facility can maintain the highest standards for cleanliness and safety. It’s essential to have an SOP in place that accounts for all necessary cleaning procedures so you don’t miss any critical steps or put your production or consumers at risk.
WHY IT’S IMPORTANT TO HIRE THE RIGHT PROFESSIONAL
As you can see, proper cleaning and maintenance of process equipment is no small task. That’s why hiring the right professional is critical to ensure your SOP meets all standards here in the United States — or wherever the products will be sold.
A qualified expert understands the specifics of each job and can customize an SOP that meets good manufacturing processes without sacrificing quality or safety. Additionally, they have the knowledge and experience to help you create a schedule that satisfies your business and regulations.
From high-temperature cleaning to understanding dwell time, having the right professionals in charge of your equipment maintenance can ensure you are always compliant and safe.
GETTING STARTED WITH TECHNICAL CLEANING FOR A GMP FACILITY
Ready to get started with following good manufacturing practices for your production facility? Talking with an industry-leading expert like A&A Elevated Facility Solutions can help set you up for success.
We’ll work with you to develop an SOP that meets your needs, complies with regulations, and helps ensure the safety of your employees and customers.
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