GMP Equipment Documentation & Template Package

Yes. While similar, your facility will need certification in both US and EUGMP standards in order to sell any hemp based products from the United States to Europe.

This can be advantageous overall when entering the markets of other countries as the standards of EUGMP are notably high. This allows for the potential access of a multinational European CBD market as opposed to a singularly American market.

Any manufacturer of food or active substances is required by law to adhere to GMP standards.

In the United States, GMP standards are enforced by the FDA. This can be monitored through regular facility inspections that ensure a manufacturer is complying with cGMP standards during production.

Serious violations of those standards, can result in product recall or other serious repercussions that could severely impact the manufacturer in terms of profit loss and operations.

From producer to customer, these GMP standards are essential to ensure quality and consumer safety. Without these standards, it would be all too easy for manufacturers to cut or compromise quality practices that are implemented for the end user to receive a good, safe product.

This applies to risk of contamination, mistakes like mislabeling, consistent product contents, etc. Not only could this lead to a product that may be unsafe, it could lead to a product that is essentially ineffective.

Unless you intend to keep your market in your own country, it is important for you to pay attention to (and abide by) both cGMP and EUGMP standards. The CBD industry is often referred to as the wild west because of its rapid legalization without the standardization to match. While that research is being conducted, producers can confidently create a product that is safe and effective for their customers by adhering to these GMP guidelines.

Though similar, there are a few key differences between cGPM and EUGMP. In both instances, a yearly review of manufacturing practices and product quality is required.

The FDA “Annual Product Review” (APR) is implemented to evaluate the quality standards of each drug product annually and also determines the necessary changes in specifications and operating procedures.

The primary task of the EU ”Product Quality Review” (PQR), however, is to focus primarily on the overall quality and manufacturing system and to show that any manufacturer is consistent in quality control when creating their products.

Current Good Manufacturing Practices, or cGMP, is a set of standards defined by the FDA that are intended to ensure acceptable manufacturing processes in regulated industries like pharmaceuticals, food and supplement manufacturing.

These standards can apply to: assurance of raw material quality, testing parameters, standard operating procedures, quality management, identifying and investigating deviations, etc. All of these standards intended to mitigate potential risks of contamination, quality failure or any other impact to potential customer safety.

Essentially the same principle, EUGMP standards are set instead by the European Medicines Agency intended to ensure quality and safety of products in the food and pharmaceutical industries.