Manufacturers wishing to sell their medicinal products in a majority of markets must comply with Good Manufacturing Practice (GMP), which requires that medicines:
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product.
In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related. However, because cannabis remains illegal at the national level, none of the federal agencies that would normally develop GMP guidelines have begun to do so, forcing state lawmakers and business owners to navigate this new, rapidly developing industry without uniform guidance from the federal government. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. These guidelines generally become the gold standard those wanting to succeed in the cannabis industry should uphold.
Cannabis produced by GMP-certified growers gives consumers peace of mind when making their purchase. Without it, sales can suffer, since discerning consumers want to know they are buying safe, quality products. In turn, having a safe, quality product will promote increased sales through solid reputation. As regulations and laws continue to develop, soon any licensed producers of cannabis will be required to meet GMP standards to maintain the credibility and licensing of their business. By getting GMP certification now, you are not only promoting the quality of your product but also saving yourself from potential licensing issues in the future.
GMP guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food, pharmaceutical, and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with legislation.
All guidelines follow a few basic principles:
Practices are recommended with the goal of safeguarding the health of consumers and patients, as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed “adulterated” if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition that violates or does not comply with current good manufacturing guidelines. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.
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