The manufacturing industry has made an incredible economic impact on the United States. According to IBISWorld, it is worth at least $7 trillion in 2023. However, with this growth comes increased regulation and expectations for quality control.
Current Good Manufacturing Practice (cGMP) regulations provide manufacturers with a baseline of requirements to ensure product safety and protection against liability issues and recall. Understanding cGMP regulations is essential to maintain compliance with these guidelines.
What Is cGMP
Well, cGMP regulations are essential; that’s what is mentioned above. But what is cGMP? The term “cGMP” refers to the current good manufacturing practice regulations. These rules govern how drugs and medical devices are produced, packaged, and stored. They’re intended to ensure that consumers get safe products and prevent manufacturers from making unsafe ones.
The FDA has been enforcing cGMP since it was enacted in 1990 through inspections of manufacturing facilities. The FDA inspects about 2% of facilities each year. If they find violations during these inspections, they can take action against companies ranging from warning letters to revoking their licenses or seizing their products until problems are fixed.
As stated by American Cleanroom Systems, a company offering the pharmaceutical, medical device, and industrial cleanrooms provider, cGMP has taken over Good Manufacturing Practices (GMP) as the pharmaceutical and medical device manufacturing standards. Some new cGMP features include continuous digital temperature alarms, hands-free bootie systems, etc.
Understanding cGMP Regulations
CGMPR regulations are a set of standards for manufacturing drugs. These standards are designed to ensure the safety and effectiveness of the drug products that reach consumers. These regulations are enforced by the Food and Drug Administration (FDA), which ensures that all drug manufacturers follow them when producing their medications.
As you might imagine, this can be challenging, especially if you don’t know exactly what cGMPs mean or how they work in practice. But understanding these regulations is essential to ensure your company stays compliant with federal law while protecting patients from harm caused by unsafe products or practices at your facility.
If any company violates cGMPs, it will face strict action from the FDA, which may also lead to seizure or an injunction case in court to address CGMP violations. As an aftermath, the authorities can also take control of the adulterated drugs.
Implementing cGMP Regulations
CGMPR regulations are in place to ensure the quality of pharmaceutical products and protect the health and safety of patients and the public. The cGMP regulations require that manufacturers establish and maintain a quality management system (QMS). The QMS should be designed to monitor, evaluate, and control production processes that affect product quality.
A QMS includes routine monitoring procedures and investigations into problems when they occur or are discovered. These procedures should be documented in writing so they can be used by all members of your staff who work on different aspects of your operations, from manufacturing through distribution, to ensure consistency across all areas.
Developing a Quality Management System
Developing a quality management system is important to ensure that your company complies with cGMP regulations. A quality management system is a set of policies, procedures, and controls that help companies implement cGMP regulations.
To develop a quality management system:
- Define the scope of the project.
- Establish goals for your project team members’ roles in developing the QMS.
- Identify key performance indicators (KPIs) that will be used to measure progress toward meeting those goals during the implementation of your QMS once it has been finalized by all parties involved in developing it.
Recently, the FDA has issued three warning letters to violating manufacturers. In the first offense, the FDA found that one Istanbul-based drug manufacturer failed to test samples from suppliers. The other two letters were issued to sanitizer makers and mask makers.
Establishing Standard Operating Procedures (SOPs)
A Standard Operating Procedure (SOP) is a document that outlines the steps needed to perform a specific task or activity. SOPs are essential for maintaining compliance with cGMP regulations because they help ensure that all employees follow the same procedures, which helps prevent mistakes from occurring.
SOPs should be reviewed regularly to ensure they are current with current requirements and processes and any changes in equipment or technology used in your facility. The best way to do this is by performing internal audits on an annual basis, where you can go through each SOP and make sure it’s still accurate and relevant.
Any changes made since last year’s audit should be documented so everyone knows what has changed and why those changes were made.
Additionally, ensure each SOP contains clear instructions on how its tasks should be performed, describing what needs doing without leaving anything out and including appropriate references if multiple documents are involved. Also, check whether enough detail is provided; if not, add more information until everything seems satisfactory.
Conducting Employee Training
Training is an important part of the quality system and should be provided to all employees. Training should be provided to new employees as soon as possible after they’re hired, but no later than their first day on the job. When conducting training, you must ensure that it’s consistent with your company’s policies and procedures and covers everything relevant to each job function within your facility.
You can conduct training for cGMP regulations in various ways, such as the following:
- Through classroom instruction or online courses
- Through videos at meetings or conferences
- Through manuals or other written materials that explain how things work in your organization
It doesn’t matter how you choose to get this information across; just make sure everyone gets it.
Conducting Internal Audits
Conducting internal audits can help ensure that the company complies with cGMP regulations. Company employees conduct internal audits and focus on various areas of operation, such as quality assurance and production processes.
The results of these audits should be used to identify areas where improvements need to be made. This will help keep your medical device company in good standing with FDA inspectors who regularly conduct unannounced inspections at facilities that manufacture medical devices.
FDA also inspects companies operating in the EU to ensure that even the products imported to the US are of quality standards. In 2021, Germany, Spain, and Belgium faced the highest number of drug quality inspections by the FDA, standing at 10, 5, and 4, respectively.
Maintaining Compliance with cGMP Regulations
Maintaining compliance with cGMP regulations is critical to ensuring that your products are safe and effective.
The cGMP regulations ensure that products are manufactured under conditions that provide quality, purity, and potency. They also require manufacturers to maintain records demonstrating how they manufacture their products so that quality can be assessed throughout the distribution chain.
The goal of these requirements is twofold. Firstly, they protect patients from exposure to unsafe or ineffective drugs or devices. Secondly, they help ensure that only high-quality medicines reach consumers through an efficient supply chain system.
The benefits of compliance with cGMP regulations are numerous. Compliance helps ensure that products are safe for consumers, which can improve brand reputation and increase sales. It also allows manufacturers to grow businesses by entering or expanding new markets. Finally, complying with cGMP regulations ensures companies remain competitive in today’s global marketplace.