What is cGMP?
The FDA enforces current Good Manufacturing Practice (cGMP) regulations, which ensure the potency, quality, and purity of pharmaceutical products. When outsourcing or partnering with another company, it’s critical to understand their manufacturing practices and facilities before integrating them into your workflow. cGMP compliance eliminates the need for conducting your own investigation of third-party offerings, saving time, reducing risk, and enhancing processes.
What Does cGMP Mean in Pharmaceutical Manufacturing?
Pharmaceutical manufacturing is a highly regulated industry due to the nature of the products and the potential risks associated with their use. cGMP regulations play a crucial role in bioprocessing, certifying that pharmaceutical products are of high quality and integrity. These regulations cover a range of manufacturing processes, from sourcing raw materials to testing finished products.
cGMP guidelines require pharmaceutical manufacturers to maintain robust quality management systems for quality control and assurance, from creating reliable operating procedures to detecting and investigating product deviations. By implementing these controls, pharmaceutical companies eliminate potential contamination, mix-ups, and failures.
What Are cGMP Raw Materials?
Raw materials used in pharmaceutical production must adhere to cGMP regulations to safeguard purity and quality throughout manufacturing. cGMP raw materials might include buffer and cell culture media, pharmaceutical excipients, and other substances such as salts, bases, carbohydrates, and amino acids.
The FDA outlines requirements for testing and approval or rejection of components, drug product containers, and closures. It dictates how to get drug products released and approved, as well as the basis on which products are rejected. cGMP regulations specify procedures for cleaning containers, preventing contamination, using sterile equipment, identifying sample containers, and more.
How Are cGMP Raw Materials Used in Bioprocessing?
Bioprocessing relies heavily on cGMP raw materials to play critical roles in various applications, each with unique requirements and standards. Let’s explore how cGMP raw materials apply to bioprocessing:
- Biologic Production: cGMP raw materials are necessary for reproducing or growing copies of a specially engineered living cell, such as monoclonal antibodies, vaccines, and gene therapies. They’re subject to strict cGMP regulations to select and test cell culture media, supplements, growth factors, cytokines, enzymes, buffers, and excipients.
- Drug Formulation & Filling: Quality can affect the final product’s stability, dissolution, and bioavailability. In fill/finish activities, leverage cGMP active pharmaceutical ingredients (APIs), excipients, and other raw materials to minimize the risk of recalls, adverse events, and regulatory sanctions, all while ensuring patients receive safe and effective medications.
- Protein Purification: Chromatography is a widely used protein purification method that separates and isolates proteins based on physicochemical properties. cGMP raw materials, such as chromatography resins, buffers, and other reagents, are used to purify the target protein. They must meet strict cGMP regulations to ensure they’re free of contaminants and won’t interfere with purification.
- Cell Culture: cGMP raw materials are crucial for growing cells in the production of biologics such as vaccines and therapeutics. Essential nutrients, growth factors, and cytokines are often required for cell growth and protein expression, and they can directly impact the yield, quality, and consistency of final biologic products.
- Dry Materials Storage: Raw materials are stored in sterile environments to maintain integrity and prevent contamination. cGMP raw materials are essential in this application, particularly for dry repacks. The materials are carefully packaged, labeled, and stored under appropriate conditions to prevent degradation and ensure their efficacy.
Comprehensive cGMP Raw Materials Handling Solutions
Contract Manufacturing Organizations (CMOs) face several challenges when handling cGMP raw materials—most commonly around supply chain limitations. Inefficient material allotment, inadequate planning, and expedited shipments for just-in-time deliveries can cause significant delays. Another challenge is warehouse capacity constraints and the inability to support additional raw materials, leading to operational and production setbacks. Further, there’s a risk of chemical exposure and product contamination, which can alter the quality and safety of final products.
ILC Dover offers solutions to help manufacturers overcome these challenges. We expanded our cGMP raw materials portfolio to meet the needs of manufacturers. We maintain an inventory of various cGMP raw materials that comply with multi-compendial grading and can make custom stocking agreements for specific quality or material requirements. We’ve also expanded our ISO 7 warehouses to provide more storage space for cGMP raw materials, ensuring a steady supply for CMOs.
- Standard Packaging Dry Repack: Prepacked powder in competitively priced, industry-standard containers and versatile packaging solutions for an economical, flexible, and scalable solution.
- EZ BioPac® Dry Repack: Prefilled, trust-weighted cGMP powders in single-use handling bags dispensed directly into vessels validated in customer processes for the safest, cleanest, and most efficient total solution.
- cGMP Custom Packaging Solutions: Tailored cGMP packaging to batch-specific container sizes. Volumes and specifications are designed to meet customer application requirements.
ILC Dover supports manufacturers at every step of their workflows, from initial planning to final production. We deliver integrated products and packaging solutions that meet cGMP regulations and help biopharmaceutical manufacturers eliminate sourcing, warehousing, testing, filling, and cleaning processes. We take a consultative approach, working to understand clients upfront and design solutions tailored to even the most complex packaging operations.
Contact ILC Dover to learn more about cost savings, materials sourcing, and quality assurance in your modern bioprocessing workflow.
