What Is GMP Certified Supplements?
The nutraceutical industry is subject to many federal regulations, known as Good Manufacturing Practices (GMPs).
GMPs for supplements are more stringent than food GMPs and set standards to assure the identity, purity, strength, quality and composition of products as well as ensure safe production processes.
What is GMP Certification?
GMP (Good Manufacturing Practices) regulations establish guidelines that manufacturers follow when producing health supplements in order to meet quality and safety standards set by the Food and Drug Administration (FDA). GMP-compliant companies must abide by higher standards; regularly audited by an independent third-party auditor will ensure compliance.
GMP certification for dietary supplements is voluntary, making compliance not compulsory and potentially leaving consumers at risk. Unfortunately, many supplement manufacturers opt out of GMP certification in order to save money or increase profit margins.
However, when selecting a contract manufacturer for your dietary supplements, it is crucial that they are GMP certified and possess all required FDA approvals. Some companies may use seals or stamps that suggest they are FDA-approved or GMP-certified; these should not be confused with actual federal approval or certification. Likewise, it’s also wise to inquire as to whether their facility complies with FDA’s current CGMP regulations.
CGMP regulations stipulate that companies producing supplements must take measures to eliminate contamination risks and ensure their ingredients match those listed on their label claims. Furthermore, companies must keep detailed records about their products and conduct regular facility inspections to demonstrate they are adhering to best manufacturing practices while producing high-quality, safe supplements.
GMP certification can be an arduous and resource-intensive process, yet there are online resources that can assist your company through this journey. Such resources include InstantGMPTM Resource Center with training videos and community of practice where members can share experiences among themselves and with other GMP-certified companies.
GMP Certification Process
GMP guidelines cover an expansive set of food safety and quality assurance operations, such as designing a clean facility for food handling training staff in food safety practices batch production records are maintained with details, investigating complaints against product failures are conducted promptly and establishing systems to investigate them thoroughly a GMP certification program is an ideal way for dietary supplement manufacturers to demonstrate they operate according to FDA specifications.
GMP certification requirements are stringent and all manufacturers, regardless of type or food supplement produced, must fulfill them to become GMP-certified. The certification process includes third-party audits, inspections and tests which once passed will result in GMP certification status allowing product packaging with their GMP-labeled labels showing compliance of production facilities.
Important to keep in mind is the fact that GMP guidelines are enforced strictly for pharmaceutical production while less stringent regulations apply when manufacturing dietary supplements, making it essential to find a contract manufacturing company with GMP certification.
GMP certification provides numerous advantages. First and foremost, it will add credibility to your dietary supplement in a crowded market; furthermore, GMP-certified companies have an established track record for producing top-quality supplements.
GMP-certified facilities will be able to comply with all FDA regulations regarding labeling, packaging and advertising of dietary supplements – this will protect both your brand and help keep out any legal complications with the FDA.
GMP-certified companies may also be more cost-effective due to not being subjected to audits and inspections from third parties – which saves both time and money in the long run. Finally, GMP certification helps businesses avoid fines imposed by regulators such as the FDA – such as financial penalties and even jail time – which may impact business operations negatively.
GMP Certification Requirements
GMP stands for Good Manufacturing Practices and refers to a set of regulations created by the FDA that ensures supplement companies adhere to quality standards set forth by them, making sure products are safe for consumption without contamination, as well as helping minimize lawsuits from consumers experiencing side effects from poorly produced supplements.
GMP certification requires a rigorous inspection of your facility, equipment and production processes. Documentation will need to be in order for every batch produced to be traceable back. In addition, employees should meet minimum qualifications to work in food handling environments while practicing good personal hygiene and knowing standard operating procedures.
As soon as your company becomes GMP certified, third-party audits from third parties will examine your facility and products to ensure they adhere to FDA standards. If an audit fails, products cannot leave your facility.
GMP certification is crucial to any dietary supplement manufacturer. Without one, the risk of losing customer trust and being accused of selling substandard products increases substantially. You can check if a dietary supplement manufacturer holds such certification by either asking directly or using an effective Food Safety Management System such as FoodDocs.
GMP certification may take anywhere from 6-18 months depending on the size and complexity of your company, facilities and systems. Once passed by an inspection from the FDA, you’ll receive your certificate to begin selling products within the US market.
GMP certification can help your business by reducing product recalls and other issues related to defective goods. Furthermore, it will allow you to build stronger relationships with customers and gain an edge over competing manufacturers; ultimately showing consumers you care for their health and wellbeing.
GMP Certification Cost
GMP certification costs are an integral component of supplement manufacturing companies. To become GMP-certified, a manufacturer must abide by a stringent set of rules related to testing, documentation and training in their production facility as well as clean and safe facilities that conform with standards designed to prevent contamination leading to product recalls or harmful side effects.
Supplement manufacturers are subject to hundreds of federal regulations which help to ensure the identity, strength, quality and composition of supplements they produce. Furthermore, these guidelines help protect consumers from unsafe ingredients or improper production methods – this system of regulations is known as Current Good Manufacturing Practices (CGMPs).
GMPs may not be necessary for all companies, but they do serve as an important way of safeguarding against unsafe or subpar products. Furthermore, these regulations help ensure a product meets FDA standards of safety and effectiveness for human consumption. Although complying with GMP regulations can be expensive and time consuming, supplement manufacturers must abide by them to meet FDA’s stringent standards.
While the costs associated with GMP compliance vary based on each business, typically it will include increased testing, inspections and third-party services; which could potentially add thousands of dollars in additional expenses for small companies.
Industry members often report that testing batches is one of the costliest elements of GMP compliance, including raw materials, co-agencies and finished products that come into contact with it. Testing also includes shelf-life dating if manufacturers opt to place expiration dates on their labels.
These additional tests are due to the FDA’s new cGMP standards, which mandate compliance from any company manufacturing dietary supplements. Due to these requirements being very expensive for supplement manufacturers, some are opting to outsource their cGMP needs instead.
GMP certification offers many benefits to food businesses, yet can be an expensive investment for food businesses. Not only does it necessitate additional inspections and third-party services, it requires additional staff as well as a more extensive documentation system. Though the cost may seem excessive at first, supplement manufacturers must comply with cGMP regulations in order to continue producing quality products.