Biotechnology sales require adherence to rules and regulations that protect both the companies and patients involved. These practices are commonly referred to in the community as GMP or good manufacturing practices.
In the United States, these regulations are enacted and enforced by the Food and Drug Administration (FDA) to ensure product quality and safety. Also referred to as cGMP or current good manufacturing practices, they are regularly updated and require companies to comply with policy changes.
GMP adherence is important to companies and consumers and protects both by ensuring the quality of products. GMP details the appropriate condition of production facilities, well-maintained and functional equipment, properly trained personnel, and reliable and documented manufacturing processes. Following GMP allows manufacturers to control the production process and helps to ensure product quality.
GMP regulates every aspect of product manufacturing, starting from design and manufacturing through distribution and packaging. GMP regulations cover two main areas:
The FDA sets and enforces these key regulations to maintain a quality standard of pharmaceuticals, devices, diagnostic test kits, and other biotech products.
GMP covers design, controls, maintenance, and active monitoring of product development and manufacturing, following the product through every step of the process. These areas can be divided into five categories or the 5 Ps of GMP:
GMP requires facilities to maintain cleanliness to consistently prevent injury or accidents. Clean facilities reduce cross-contamination and add to a product’s quality assurance. Equipment must be maintained, stored, and regularly calibrated for optimal performance.
Staff must be properly trained with a clear understanding of their roles and expected hygiene standards. Staff members are delegated responsibilities with clear SOPs (standard operating procedures) that integrate and outline how to maintain GMP requirements during production. Employees are integral to quality assurance.
Comprehensive documentation is a main component of GMP compliance and is crucial for product traceability and company accountability. Each step of the product manufacturing process should be documented and SOPs closely followed to ensure accuracy. There should be clear document control regulations and regular checks to confirm compliance.
Products are covered under multiple requirements, including increased testing and quality control, control of raw materials and sourcing, and product packing and distribution.
Products are subjected to quality control testing at various stages of production to guarantee product grade and specifications. Products that do not fall within the predetermined parameters for GMP cannot be approved for distribution.
Reliable and sustainable sourcing of raw materials is a significant aspect of proper GMP compliance. Raw materials are subject to the approval of the FDA and undergo strict quality testing and verification to provide safe final products. Tracking and vetting sourcing of raw materials also decreases the risk of contamination and harm.
GMP details considerations for packing and labeling products accurately and appropriately. Errors or unclear labeling are non-compliant and can be held against a company’s overall GMP evaluations.
Packing and labeling rules vary depending on the product and the level of risk associated with the intended use. Riskier products are subject to greater regulatory scrutiny. These requirements are in place to maintain proper storage conditions and product integrity throughout distribution to prevent degradation or contamination of the product.
Each company should have clear process controls in place to maintain the efficiency and functionality of product manufacturing processes. These processes should be regularly reviewed and validated to demonstrate consistency and quality.
Improvements to the production processes are closely monitored and evaluated for impact on product quality. Process control compliance solidifies product continuity.
Depending on the commercial applications of the products produced, GMP is often highly beneficial for companies both launching and maintaining business in the biotechnology industry. To sell products in certain market segments, such as clinical manufacturing, GMP compliance is essential. Certifications and regulatory approvals are commonly based on GMP compliance and are integral to increasing company market access and international expansion.
GMP compliance also assures the safety of the product and consumer, reducing the risk of error and product deliverable deviation. Companies embracing GMP continuously improve their operational efficiency by cultivating a culture of reliable and high-quality manufacturing.
Initial GMP violations incur regulatory actions and penalties, such as warning letters, notices, fines, and fees. They also result in significant erosion of customer trust. Repeated, severe, or unaddressed violations can lead to more serious consequences, including product recalls and withdrawals.
Recalls often cause a market impact, forcing companies to act quickly to address quality issues promptly to remain viable in the marketplace. The FDA can also bring charges against companies for failing to comply with CGMP or current good manufacturing practices, damaging a company’s reputation and market trust.
Every biotech company should have a clear and concise GMP plan that all staff are familiar with and confident in enforcing. GMP protects companies and consumers from contamination and faulty or low-quality products and is an important part of biotech product safety.
Akadeum takes our own GMP very seriously, and we are proudly providing GMP-compliant products and processes to our clients for their research. Our Human T CellLeukopak Isolation Kit – GMP is made with compliance and quality assurance in mind. We provide firm documentation and processes for traceability and peace of mind.
Available now in our line of GMP products is our innovative Human T Cell Activation and Expansion Kit – GMP, perfect for expanding T cells ex vivo. Learn more about how Akadeum maintains GMP compliance by contacting our team today.
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