cGMP Regulations | Processes & Standards
Global Widget is committed to setting the gold standard in CBD manufacturing by following current Good Manufacturing Practices (cGMP) and continuing to place quality and compliance first. The way we see it, following cGMP regulations lies at the heart of a successful and sustainable CBD company, and everything else follows. Learn more about how we’re raising the bar for quality manufacturing in the CBD industry below.
What is cGMP Manufacturing?
cGMP (current Good Manufacturing Practice) standards are dictated by the FDA and establish the requirements for the manufacturing of various types of products. These standards provide the following guidance to manufacturers: raw material selection and testing; facility and equipment inspection, cleaning and validation; manufacturing process control and testing; packaging component selection and testing; and finally, finished goods testing and validation. There are different requirements for food items versus dietary supplements and over-the-counter pharmaceutical products, but all are in place to ensure a safe, quality product for the end consumer.
What is the FDA looking for?
The FDA considers four areas when evaluating cGMP regulations:
Documentation
Global Widget is committed to keeping meticulous records of each step throughout the entire manufacturing process including raw material selection and testing, production, and finished good testing. Our commitment to quality translates into establishing and following written procedures for all aspects of production. In addition, we have equipment setup protocols for reliable and consistent verification — all documentation must be reviewed by trained personnel different from the employees who recorded the initial information. A Batch Record is an excellent example of this type of detailed and robust documentation.
Supply Chain
We go above and beyond the FDA’s vendor verification requirements. Global Widget has standards in place to qualify our suppliers, and we document our vetting process in detail. This ensures that our raw materials are of the highest quality and safety.
We utilize a detailed New Vendor Packet, which potential vendors are asked to complete prior to consideration. If a potential vendor does not meet or exceed the extremely high Global Widget standards, they will not be considered. Global Widget also performs an audit on its vendors to verify each vendor is meeting cGMP standards.
Process Controls
We have dedicated a great deal of time and energy to create and adhere to a system of production and process controls covering all stages of manufacturing. Process controls are in place for each component used during production and affect things like theoretical yield (how much we expect each batch to yield), how our machines work, and the SOPs created for the manufacturing process. The many years of combined experience of our staff, coupled with our unwavering commitment to the gold standard we have set, means we are able to execute established process controls at all times and in all facets of production.
Quality Assurance
Global Widget has implemented industry-leading quality assurance protocols in our manufacturing, packaging, labeling, and holding operations to ensure the exceptional quality of our products and that our products are packaged and labeled as specified in our master batch records. QA protocols are in place to make sure…
Everything meets specifications
Equipment is validated
Third-party lab testing is completed
Supply chain quality is verified
Risks of cGMP Non-Compliance?
The largest concern when deviating from cGMP standards and CBD regulations is safety. Manufacturers that do not follow cGMP standards run the risk of distributing dangerous products to the consumer market. These products may not be safe and effective, and they may contain harmful ingredients that can cause injury or death.