The aim of our quality assurance is to provide credibility to secure that our offering of high quality bioactive products and a documented dietary advice guide will satisfy our customers need for security. Lipomic Healthcare’s own quality system follows the FDA’s Current Good Manufacturing Practice (CGMP) for the Dietary Supplement, 21 CFR, Part 111.
Lipomic Healthcare approves only suppliers of raw materials and producers of ready products that operates according to the rules layed down in our quality assurance system. To be approved our suppliers must document that they have a good quality assurance system and ensure that the service they provide are following classifications such as GMP and ISO certifications.
Good Manufacturing Practice (GMP)
GMP is a set of rules that describe the requirements for quality systems, personnel, premises, equipment, documentation, production, quality control, contract manufacturers, complaints, recalls, and self inspection. A GMP certificate from our supplier indicates that the products are manufactured in accordance with established policies, ensuring the quality in terms of content, purity and labeling.
To summarize briefly the GMP regulation comprises that:
• The production equipment and production process is approved
• Any part of the manufacturing process is documented
• Cleaning of manufacturing and production facilities is documented and controlled
• Identification, labeling and packaging of raw materials is checked
• Finished products shall be identified by a batch number
The internationally recognized ISO 9001 standard
The internationally recognized ISO 9001 standard is generic and was designed to establish international requirements for a management system for quality management. This certification is performed by an independent third party, often an accredited certification body, and lets customers know they can rely on that the manufacturer / provider has implemented the necessary internal processes to meet obligations.
Important elements of this standard are:
• Quality Management System
• Management responsibility
• Resource Management
• Product sales
• Measurement, analysis and improvement
Food safety
Food safety is associated with the knowledge that the food you eat is safe to consume, and that there are no health risk when eating it. Foreign substances, or traces of such, are present in nearly all foods and can occur naturally or as a result of pollution. The contaminants can for instance be biochemical substances which can cause health problems if they are present in quantities over a certain level. What level is undesirable varies depending on the type of contaminant. For known contaminants defined threshold levels for what is legal maximum limit in products to be consumed is set.
Our suppliers perform checks to ensure that contaminants are not over the limit in the pre-manufactured products. Examples of contaminants we don’t want in oils for human consumption are heavy metals, PCBs (polychlorinated biphenyls) and dioxins. Additionally is microbiological analyzes performed to prevent the presence of potentially harmful microorganisms.