GMP During Covid-19

Vitalis GMP During COVID-19

 

THE FUTURE OF MANUFACTURING

In the global race to combat the pandemic with medical supplies and vaccines, the role that manufacturing plays has never been more important. While the pace of production is where minds may go first, what’s proving to be an invaluable lesson in times like these regardless of industry, is ensuring operations meet levels of regulatory compliance, quality assurance, and safety.

Governments around the world are leaning heavily on manufacturers who have the capacity or the ability to pivot their operations to produce critical medical supplies from personal protective equipment (PPE) to ventilators and testing kits - and the inevitable pharmaceutical race to produce a vaccine. The common theme in the manufacturing of these items is that they must meet Good Manufacturing Practices (GMP) to ensure the products are safe, effective and of high quality. While the time factor is certainly crucial, deviating from GMP standards and practices could mean the creation of defective products, and unsuccessful attempts to deliver life-saving support.

 

FDA Regulation & GMP Compliance

Even for the most unsuspecting of industries and companies, especially those in the cannabis space, what we are facing today, is a reminder that preparing for the future is not only smart, it’s good business practice. With cannabis classified as an essential service, we’ve seen a knock-on-effect of an increase in the distribution of licenses, including those in the pharmaceutical and consumable spaces. Edibles and topicals are the fastest-growing segment of the cannabis market - U.S. retail sales of cannabis and CBD products reached $14 billion in 2019, and are on pace to increase 18% a year to $33 billion by 2024, according to data published in “Cannabis and CBD: U.S. Retail Market Trends and Opportunities,” by market research firm Packaged Facts. 

The new trend in cannabis production has dictated that when it comes to producing products bound for human consumption, it isn’t about getting there first, it’s about getting it right. The FDA is close to implementing new standards for regulation of cannabis-infused products, especially within the CBD markets to patrol any misleading health claims. What’s important for cannabis producers in the USA to know is that while you can’t get FDA GMP certification currently, there are steps you can take now in structuring your businesses to be FDA compliant in preparation for new regulations coming in the future.

The billion-dollar cannabis industry is growing, even in economic periods of uncertainty like these, which means planning for the future has to start today. Gaining or at the very least preparing for GMP accreditation is not only a step towards accessing new cannabis markets, but it’s just as important to improving brand reputation. When consumers see a GMP-labelled cannabis package, they know the product is safe, high quality, and effective. GMP accreditation also fosters trust with supply chain partners (as can be seen in the recent COVID-19 manufacturing partnerships), which saves time and money in securing deals when new opportunities present themselves.

 

GMP Equipment Qualification

How exactly do you achieve GMP? GMP covers all aspects of a manufacturing operation, so it's important that your suppliers can support your GMP requirements, from raw materials and facility design, to equipment and packaging. And when it comes to your extraction machine - scrutiny for qualification is placed on the way it was fabricated, built, and tested, as well as commissioned. Extraction equipment must be designed and constructed in a way that is streamlined, safe, and reliable, reducing chances of contamination, and be able to withstand repeated use and cleaning.

How a manufacturer meets GMP regulations is entirely up to them as GMP regulations have been structured to allow such flexibility. While it is the responsibility of every cannabis product manufacturer to bring their production facilities into compliance with GMP regulations, it’s definitely not a journey that one should embark on alone. Given the massive scope and highly technical nature of GMP across every area of business operations, it’s vital to get the help of an experienced consultant or expert early to assist with the design, planning, qualification, validation, and manufacturing processes.

As experts on the design and construction of our equipment, our team of GMP experts are there to reassure customers that Vitalis equipment can be qualified within their GMP environment by walking them through a 5-step process towards achieving GMP Qualification.

As an international GMP-compliant equipment supplier to the pharmaceutical and recreational cannabis industries, Vitalis specialists not only have a deep understanding of not only Canada's Good Production Practices (GPP), but GMP regulations around the world and will ensure that the qualification of the Vitalis equipment goes smoothly. To join our list of customers enjoying successful GMP operations, reach out today.

 

 

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