What Is Clinical GMP?

Updated on Feb 20, 2024 By Jason Ellis, PhD Share

Good manufacturing practices (GMP)—are system that ensures products are consistently produced according to quality standards—is a concept most in the biotech industry are familiar with. But what exactly is clinical GMP?

Clinical GMP specifically refers to the guidelines associated with products intended for human medical use. Unlike general GMP, which can pertain to various industries, clinical GMP focuses specifically on products intended for human consumption or application, ensuring that medical/medicinal products are safe, effective, and of high quality.

Similarities and Differences Between GMP and Clinical GMP

While both GMP and clinical GMP emphasize quality control, consistency, and reliability, clinical GMP is finely tuned for pharmaceuticals and clinical trials. The regulations are more exhaustive, focusing on avoiding cross-contamination, ensuring product stability, and establishing clear documentation, which is particularly crucial when dealing with investigational drugs and treatments.

Similarities

1. Core principles: Both emphasize quality, consistency, and reliability in manufacturing. An emphasis on documentation and process validation is common.
2. Regulatory oversight: Both sets of guidelines are overseen by similar regulatory bodies, like the U.S. Food & Drug Administration (FDA), U.S. Department of Agriculture (USDA), and their counterparts in other countries.
3. Safety concerns: Both prioritize consumer and patient safety above all else.

Differences

1. Focus: GMP can pertain to various industries, including food and cosmetics. Clinical GMP is specific to pharmaceuticals and products for human consumption or application.
2. Guidelines specifics: Clinical GMP has more stringent rules, especially for avoiding cross-contamination and ensuring patient safety. Clinical GMP has a particular emphasis on documentation needed for investigational drugs.
3. Risk assessment: While both assess risks, Clinical GMP requires a more in-depth risk analysis due to the direct implications for human health. For pharmaceutical and medicinal products, there’s no room for error; human lives are at stake.

Why Is Clinical GMP Essential?

Imagine a scenario where a drug, intended for human application, is manufactured without strict quality control. The drug may become contaminated or contain a harmful amount of certain ingredients—the results of which could be catastrophic.

• Safety first: Clinical GMP ensures a stringent quality process so that every product is consistent and meets defined standards. This mitigates the possibility of discrepancies which could affect a drug’s efficacy or safety.
• Public trust: By adhering to clinical GMP, companies build public trust in their products, assuring consumers these products have undergone rigorous quality checks.
• Regulatory compliance: Meeting clinical GMP standards is often a legal requirement. Governments may implement sanctions, fines, or recalls on products that don’t meet the standards set in place.

The FDA and Its Relationship With Clinical GMP

The FDA is the U.S. federal agency responsible for ensuring that foods, drugs, medical devices, and certain other products are safe and effective by holding manufacturers to industry-dependent standards. The FDA maintains an updated version of their GMP guidelines, referred to as the Current Good Manufacturing Practice (cGMP) regulations. Companies that fail to meet good manufacturing practices can face severe penalties, emphasizing the necessity of these rules in the manufacturing process.

The FDA is responsible for:

1. Protecting public health: The primary aim of the FDA’s relationship with clinical GMP is safeguarding public health. Ensuring that medical devices and drug products are consistently produced under stringent quality control measures minimizes potential health risks to the public.
2. Approval process: Before any drug product or medical device reaches consumers, it must go through a rigorous approval process. Adhering to the FDA’s cGMP guidelines is an integral part of this approval process. Any discrepancies can lead to delays or outright rejections of approval applications.
3. Inspections: To ensure companies adhere to clinical cGMP standards, the agency frequently conducts audits. These inspections can be planned or unannounced, keeping businesses on their toes and emphasizing the importance of always maintaining compliance.
4. Feedback and continuous improvement: Post-audit, the FDA provides feedback and recommendations to drug and medical device manufacturers, highlighting areas for improvement. This feedback loop ensures that companies continually refine and enhance their manufacturing processes, aligning with the latest cGMP.
5. Guideline enforcement: The FDA is the primary federal agency responsible for enforcing clinical GMP regulations. While the agency aims to mitigate the need for fines and recalls through warnings and recommendation notices, repeat offenders will be sanctioned.

Batch Processing and Packaging Requirements

Manufacturing and processing under clinical GMP for biologics and therapies is vital to ensuring a product’s consistent quality, safety, and efficacy. These requirements include:

• Batch/lot records: Every manufacturing process step needs to be meticulously documented. This ensures traceability, so any anomalies can be traced back to a specific lot.
• Sterility: Biologics and therapies often require a sterile environment to prevent contamination. Clinical GMP emphasizes sterility tests and controls for biologic products.
• Validation and testing: Before shipping, each batch undergoes rigorous validation and testing. This ensures that the product meets the necessary safety and efficacy standards.
• Packaging integrity: The packaging must ensure product stability and protect from contamination. Clinical GMP rules detail the suitable materials and processes.
• Labeling requirements: All necessary information, including batch number, expiry date, storage conditions, and more, must be clearly referenced. Labeling also aids in traceability and ensures the end user is well-informed.
• Storage and distribution: Once boxed, the products must be stored under specified conditions to maintain efficacy. The guidelines also regulate the distribution process to ensure the product reaches its destination without compromise.

The Future of Clinical GMP at Akadeum

Quality has been the standard from the start at Akadeum.

While we continue to release GMP versions of our innovative buoyancy-activated cell sorting (BACS™ ) microbubble kits—including our Human T Cell Leukopak Isolation Kit and Human T Cell Selection, Activation, and Expansion Kit – GMP—our sights are set on the development of kits recognized as being clinical GMP compliant. Given the significance of researchers entering their therapy candidates into clinical trials, these kits will be tested and aligned with stringent clinical GMP standards.

With its emphasis on ensuring safety, effectiveness, and quality, clinical GMP remains the gold standard for products intended for human use. Akadeum is excited to continue to play our part, ensuring that every kit manufactured meets these critical standards—allowing you to focus on your research.

Reach out to our team today for the latest developments on our clinical GMP-grade line of cell sorting kits.