Good Manufacturing Practice (GMP)

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Manufacturers wishing to sell their medicinal products in a majority of markets must comply with Good Manufacturing Practice (GMP), which requires that medicines: 

  • are of consistent high quality
  • are appropriate for their intended use
  • meet all applicable requirements

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. 

GMP for the Cannabis Industry

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.

Benefits of GMP

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.

Key Benefits: 

  • Prove an organization’s management capabilities in product quality, safety assurance 
  • Enable employees to develop good production / operational habits 
  • Reduce safety risk
  • Timely detection of production and management problems, reduce cost 
  • Better understand and comply with the relevant laws and regulations 
  • Enhance international credibility and public image 
  • Increase customer’s long-term confidence in the enterprise 

GMP Guidelines 

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: 

  • Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area. 
  • Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption. 
  • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. 
  • Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. 
  • Instructions and procedures are written in clear and unambiguous language.
  • Operators are trained to carry out and document procedures. 
  • Records are made, manually or by instruments, during manufacture that demonstrate all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented. 
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. 
  • The distribution of the food or drugs minimizes any risk to their quality. 
  • A system is available for recalling any batch from sale or supply.

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.

FREE GMP Checklist

Please click here for a free GMP checklist. Note: This leads to our contact us page, please provide your information and type “GMP checklist” into the message section.

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