If you’re new to the world of biotechnology manufacturing, you’ve likely heard the term “current Good Manufacturing Practices” or “cGMPs” a lot. These regulations, enforced by the U.S. Food and Drug Administration (FDA), can help assure your customers of your product’s quality and protect your company from criminal penalties. Here are a few things you should know about what current Good Manufacturing Practices are for the biotech industry and why you should follow cGMPs.

What are Current Good Manufacturing Practices (cGMPs)?

Current Good Manufacturing Practices, or cGMPs, are regulations set out by the FDA regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. These regulations cover every step of production, from the raw materials, premises, and equipment used to the training and personal hygiene of staff. Good Manufacturing Practices involve establishing robust quality management systems, using quality raw materials, establishing strong operating procedures, detecting and addressing deviations in product quality, and maintaining reliable laboratory testing of all products.

In the biotech and pharmaceutical industries, adhering to cGMPs can help prevent contamination and failure and ensure the quality standards of pharmaceutical drugs, medical devices, diagnostic test kits, and other biotechnology-related products. Two specific cGMP regulations relate to biotech manufacturers: one relating to biological products and one relating to electronic records and signatures.

The “c” in cGMP means that companies must use up-to-date technologies and management systems in order to fully comply with the regulations. However, the cGMP requirements were established to be flexible so that each manufacturer can decide how to best implement science-based design, processing, and testing procedures. In addition, cGMPs are only minimum requirements, and many biotech manufacturers choose to implement quality systems and risk management strategies that exceed these minimum standards.

Why are cGMPs important?

Current Good Manufacturing Practices are designed to protect consumers by ensuring the quality and safety of biotech products. They do so by requiring manufacturing facilities to be in good condition, equipment to be properly maintained and calibrated, employees to be qualified and properly trained, and manufacturing processes to be reliable and reproducible.

By adhering to cGMPs, manufacturers can better control their production processes and the quality, safety, and strength of their final products. The flexibility of the cGMPs, and their emphasis on the latest technologies and practices, can also help biotech manufacturers continually improve their products.

How do I make sure I comply with current Good Manufacturing Practices?

The FDA has the regulatory authority to inspect biotech manufacturing facilities and plants for compliance with cGMPs. These inspections can be random or can result from reports of adverse outcomes from the public or industry.

To ensure that your product has been manufactured according to current Good Manufacturing Practices, adherence to cGMPs should be built into your facility’s Standard Operating Procedures and quality management strategy. You can find the latest cGMP regulations, guidance documents, and other resources on the FDA website (search for 21 CFR 820), as well as through the FDA’s small business representatives, district offices, and from the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality. Any updates or changes to the regulations or the guidance documents can also be found in the Federal Register.

If you are utilizing a biotech contract manufacturer, like IVD Research, Inc., make sure that your manufacturer operates under the latest cGMP guidelines prior to signing a contract with them.

What happens if I violate current Good Manufacturing Practices?

If a company violates cGMPs, it runs the risk of releasing a poor quality product. In such a case, most companies will voluntarily recall that product from the market. In addition, the FDA may take several steps in response to a violation of cGMPs by a biotech or pharmaceutical manufacturer. If a company refuses to recall a drug or product, the FDA can seize that product and issue a warning to the public. The FDA can also bring a seizure or injunction case against a company to court; these cases will often lead to court orders requiring companies to correct cGMP violations by repairing facilities and equipment, improving staff training, improving sanitation conditions, or performing additional tests to verify product quality. Finally, the FDA can also bring criminal cases in response to cGMP violations; in such cases, manufacturers can face fines and even jail time.

By fully understanding and adhering current Good Manufacturing Practices, you can ensure that your biotech or pharmaceutical product meets the latest regulatory requirements, saving you time and money. For more information about how IVD Research keeps up with the latest cGMP guidelines for biotech manufacturing, contact us today.