A Good Look at GMPs
Good manufacturing practices (GMPs) were set in motion as a response to concerns over substandard manufacturing procedures within the pharmaceutical industry. The first set of GMP regulations was published by the Food and Drug Administration (FDA) in 1963 to help guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs were considered minimum requirements necessary to ensure product safety. Today, GMPs don’t just help set the standard for the pharmaceutical industry; they also set the guidelines for food and supplement manufacturers.
What Are GMPs?
GMPs are required guidelines that are enforced by agencies that control the manufacturing and sale of food, pharmaceutical, and supplement products.
They’re also referred to as cGMPs—current good manufacturing practices. These guidelines provide the requirements by which a manufacturer must abide in order to maintain a high level of quality and consistency and to ensure products don’t pose any risk to the consumer. GMPs are overseen by regulatory government agencies such as the FDA and Health Canada.
Guidelines of GMPs
GMPs provide guidelines for everything involved in production, testing, and quality assurance. These guidelines help to maintain a high level of quality and cover many areas, including the following:
• Manufacturing facilities, processing, and packaging
• Clean and hygienic facilities and procedures
• Qualifications of staff
• Prevention of cross contamination (allergens) and appropriate labeling
• Environmental conditions
• Quality and laboratory controls
• Records of all manufacturing, including logs of all batches
• Examination of complaints with respect to quality of the product
Why Are GMPs Important?
GMPs ensure that the products you’re purchasing are of consistent high quality and are safe for consumption. GMPs help protect the consumer. Any product that is manufactured in a facility that violates or doesn’t comply with current GMPs will be considered “adulterated” and unsafe. Complying with GMPs is mandatory, and it’s the responsibility of the manufacturer to abide by its own set-out procedures and processes. Failure to comply with these regulations may result in regulatory action against the company responsible for the failure.
What Do GMPs Mean to You?
GMPs help protect against unsafe and ineffective products that might not be easily spotted by the consumer. For example, GMPs can help ensure that every batch contains the same strength of ingredients and is free from unsafe ingredients. GMPs help ensure that what’s stated on the label is exactly what’s in the bottle you’re purchasing.
Who Enforces GMPs?
Trained inspectors examine facilities around the world for compliance to set GMPs, including those facilities that produce the active ingredients and final products. To ensure compliance, these inspections can be carried out routinely but also unannounced. Inspectors also review consumer and industry complaints filed about products, using these reports to identify sites that could benefit from inspection. Throughout the world, GMPs are enforced by different regulating bodies, including the WHO, the European Union, and the FDA and other similar agencies throughout Canada, Australia and Asia.
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