Dianne Pajo
No one wants unsafe pharmaceutical products. Thanks to the FDA, the organization ensures that facilities make quality batches of drugs. The FDA awards certifications that prove manufacturers are using good practices. Keep reading to learn why GMP certification is important for drug development.
Understanding GMP Certifications
GMP refers to Good Manufacturing Practice, which are FDA regulations for manufacturing facilities. GMP assures proper monitoring and control of manufacturing processes. Companies adhering to these regulations ensure medication identity, quality, and purity.
GMP certification is important for drug development because it prevents contamination, errors, mix-ups, and abnormalities. The FDA ensures that pharmaceuticals meet their quality standards. To receive certification, the FDA audits facilities. A representative assesses management systems, raw materials, operating procedures, and quality deviations. The in-depth investigation ensures that companies use safe practices.
Their Importance to Consumers
Generally, a consumer can’t tell if a drug product is safe or effective just by looking at it (especially capsules and pills). The FDA requires testing of all products. Manufacturers create a sample batch and document the entire manufacturing process. If problems arise, they change ingredients or methodology. If everything goes well, they repeat procedures. The goal is to create reliable and reproducible products for consumers.
People ingest medication, vitamins, and dietary supplements. Off-balanced pharmaceuticals can have dangerous, sometimes fatal, consequences. Qualified professionals recognize the importance of high-quality products and acknowledge their commitment to consumers.
How the FDA Helps
The FDA awards certifications to facilities that adhere to their regulations. The organization audits manufacturers and assesses their processes. It’s a thorough investigation with several analyses. The auditor identifies violations or problems and requires that companies fix these issues to receive certifications.
When companies meet these standards, they receive a stamp of approval. Please note that a GMP certification lasts up to three years. After this period, the FDA audits manufacturers to ensure they continue to follow correct practices.
What Happens if Products Aren’t Certified?
If a manufacturer does not comply with FDA regulations, the organization recognizes any drugs the company produces as “adulterated.” This means the products weren’t manufactured under conditions that comply with GMP. However, it doesn’t mean there is necessarily something wrong with the drug.
While the FDA can’t force a manufacturer to recall a drug, companies typically recall voluntarily upon request from the FDA. If there are problems with pharmaceuticals and the company refuses to implement a recall, the FDA will warn the public and seize the drugs from facilities.
