GMP Certified

Why GMP is so important? 

Did you know supplement quality is completely unregulated by the FDA? This is why some supplements, when tested by third parties, have nothing close to the amount of active ingredients listed or stated on the packaging.

To add to this, some supplements even have dangerous ingredients can be added.  Several years ago, there was a male enhancement supplement was found to be laced with Viagra.  Some supplements have been shown to be laced with heavy metals or ingredients in toxic amounts that actually kill or harm you.

Over the years, the supplement industry has found ways to regulate itself. This has been through various regulatory agencies and practices that have often been borrowed from the pharmaceutical and food industries. 

The most important sets of these regulations of consumables products is Good Manufacturing Practice (GMP). The regulations ensure that the companies that produce products such as food, cosmetics, pharmaceuticals, supplements do it with a consistently of high quality from batch to batch.

History of GMP

In the early 1900s, there was no federal regulations that protected consumers and workers from dangerous products and working conditions. Chemical preservatives were uncontrolled, milk was unpasteurized, and drugs were largely unregulated.

In 1906, Upton Sinclair published The Jungle, a novel that exposed the horrid conditions of the meatpacking industry. As a result of these revelations, the government was pushed by the public into passing the Pure Food and Drug Act of 1906. While this law was a step forward, there were many gaps that left consumers unprotected. 

In 1938 the government passed the Federal Food, Drug, and Cosmetic Act. This allowed the government to inspect drugs and working conditions before marketing.

In 1962, the Drug Amendments were passed. These amendments tightened the control and regulation of prescription drugs, new drugs, and investigational drugs. These amendments formalized GMPs. Since 1962, many more sets of laws and regulations have been passed to protect consumers from bad manufacturing practices.

What are the Good Manufacturing Practices (GMP)?

GMP has been adopted by many countries around the world. They are each regulated by their respective regulatory agency. The guidelines usually follows these basic principles: 

• Requiring step-by-step written procedures
• Following step-by-step procedures
• Document work (Record keeping) 
• Validate work (Make sure there is adherence to procedures and consistent performance)
• Integrate productivity, quality, and safety into facilities and equipment
• Maintain facilities and equipment
• Define, develop, and demonstrate job competency
• Make cleanliness a daily habit
• Build quality into the product
• Conduct compliance and performance audits

The FDA is authorized to perform unannounced inspections to ensure that companies are in compliance with GMP standards. If a company/product is deemed to be in violation of GMP standards, the FDA can warn the company to recall the product. If there is no recall of the product, then the FDA can warn the public and seize the product. 

GMP and K Tropix