What Does it Mean to be GMP Certified?
What Does It Mean To Be a GMP Certified Manufacturer?
Before cannabis industries get business and customers rolling, legalities beyond the age-old issue of decriminalizing usage mandate attention. One such task assisting in quality assurance is obtaining Good Manufacturing Process (GMP) certification. Checkout the breakdown from Hara Supply.
What is GMP?
Although the acronyms differ by only one letter, GMC thrills more than GMP. However, GMP remains a driving force of manufacturing, food and pharmaceutical legitimacy. GMP is a system ensuring products are produced and controlled according to Food and Drug Administration regulations. The end result quells consumer concerns regarding product safety in design, usage and aftereffects. The FDA achieves that altruistic goal by requiring a plethora of requirements permeating processes.
What Are Requirements to Become GMP Certified?
The FDA specifically lists “establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories” as essential items on the theoretical checklist needed to obtain GMP status. Oftentimes, industry jargon simplifies these requirements into the “Five P’s.” People, premises, processes, products, and procedures ( interchangeable with paperwork) comprise the mnemonic device. The International Society for Pharmacoepidemiology provides guideline resources for Australia, Canada, the European Union, the United States of America, and the World Health Organization.
How Does the FDA Decide Whether the Inspected Business Complies with GMP Standards?
FDA inspects pharmaceutical manufacturing facilities around the globe, including facilities manufacturing active ingredients, the production process transforming active ingredients into the end product and the final product itself. Inspections follow standardized procedures spearheaded by a formal approach. Highly trained FDA staff conduct everything.
What Are the Benefits of Obtaining GMP Certification?
One less mundane item lingers in the hectic heads of executives salivating over competitive advantages. Jokes aside, becoming a GMP facility signals highly visible credibility. Customers subsequently feel safer, knowing GMP-certified businesses prioritize safety and mitigate contamination odds. Safety and quality assurance breeds comfort. Comfort sparks customer loyalty. Loyalty translates to increased business profits through higher sales and a stronger reputation.
Additionally, the cannabis industry suffers from heightened scrutiny and lackadaisical regulation in many states until legislation approves legalization on the federal level. GMP certification differentiates businesses by demonstrating it goes to greater lengths to promote quality control and customer health than competitors. In a saturated market perceived by many as seedy, a little legitimization goes a long way.
What Are Costs Associated with GMP Compliance?
The FDA calculated GMP compliance costs upon drafting the Dietary Supplement Health and Education Act of 1994.
The FDA decided that financial planning behooves firms with less than 20 employees and annual revenue of under $1 million to spend about $26,000 to ready compliance systems and about $46,000 in yearly maintenance procedures. Mid-sized establishments ranging from 20 to 500 employees and $5 to $10 million in annual revenue should plan to spend about $20,000 to set systems up and about $184,000 each year to maintain them. According to GMP compliance assistance company InstantGMP, estimates surmised that mid-size companies would already have most of the required systems prior to obtaining GMP certification, whereas smaller firms don’t enjoy identical resource capability, hence small companies must start from the beginning.
Can Manufacturers Afford GMP Implementation?
In the long run, the total benefit outweighs the total cost. For an undiscussed example, consider the unintended consequences of not completing the proper certification process. Without FDA rigors, harmful, potentially lethal errors poison the end product. That nightmare leads to dream scenarios for pouncing prosecutors fighting for compensation and punitive damages in finance and reputation-eviscerating lawsuits. Just one mislabeled barrel containing raw materials mixed in the production process potentially botches the entire end product by mixing the wrong ingredients.
Even if problems avoidable through GMP satisfaction fall short of worst-case scenarios, employees and investigative organizations locating errors and bottlenecks drain cost and time efficiency. As mentioned, the GMP certification process runs the entire production and manufacturing gauntlet, allowing business owners to obtain peace of mind instead of malevolent feedback.
What Else Could Happen if Products Don’t Meet GMP standards?
If a drug or supplement in an impacted industry fails to meet GMP standards, the company committing the offense generally recalls the product or stops issuing its sale, either voluntarily or through FDA mandates. In serious cases, the FDA can file for a seizure or injunction. The latter demands violation remedies, while the former likely involve law enforcement to confiscate the product.
What Does GMP Certification Mean for the Future of the Industry?
As legalization spreads, businesses dealing with cannabis companies expect GMP certification with an increasing frequency. Customers follow suit, especially as the market expands. More companies obtain certification, making a lack of certification a possibly immovable roadblock on the road to financial success in the industry.
Speaking of the Future, What About COVID Considerations Related to GMP Processes?
COVID ravages the business world as much as the real world. GMP considerations extend beyond having product and manufacturing handlers wear masks with a snazzy company logo. FDA officials recognize that fact and issued a final report in June titled “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry.” The report is public.
How Long are GMP Certificates Valid?
One GMP certificate is typically valid for three years. Once the audit process completes with satisfactory results, the certificate is issued in the registered company’s name. The certification shows the name and address of the company’s manufacturing site.
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How to Apply for GMP Certification
An abundance of online resources to facilitate the GMP application process exists. That said, the process varies by location. The Educational Credential Assessment Academy provides a website with support and resources for GMP compliance, including a link to the form for revision or renewal of a certificate of GMP suitability, presented by the European Directorate for the Quality of Medicines and HealthCare. Furthermore, the FDA website articulates a trove of information regarding the entire GMP certification process for the United States and international businesses.