At HawaiiMana™, the quality of our products is paramount. That is why every step of our manufactures process is designed in accordance with the United States Food and Drug Administration’s Current Good Manufacturing Practices (cGMP) for Dietary Supplements.
Our Manufactures quality control staff thoroughly tests all raw materials, blends, capsules, powders, tablets, and liquids for conformance to specifications as outlined in the United States Pharmacopoeia (USP). We employ High Performance Liquid Chromatography (HPLC), Infrared (IR) Spectroscopy, Ultraviolet/Visible (UV/Vis) Spectroscopy, Microbiological testing, Stability testing, and various other methods in order to ensure the safety, purity and effectiveness of all raw materials and finished products. The most stringent in-process quality assurance from start to finish is thoroughly and consistently maintained and monitored by manufacturing auditors.
Documentation:
Full documentation sets are provided for international orders.
• Certificate of Free Sale, Health and Sanitation
• Good Manufacturing Practices Document
• Example Product Dossier
HawaiiMana™ is committed to customer satisfaction and quality, we therefore deliver only the best of the best!
WHAT IS GMP?
“Good manufacturing practice” or “GMP” is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. as does the Food and Drug Administration’s version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan,Singapore and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as “The Orange Guide”, which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.[2]
Enforcement
Within the European Union, GMP inspections are performed by National Regulatory Agencies (e.g., GMP inspections are performed in the United Kingdom by the Medicines and Healthcare products Regulatory Agency(MHRA)); in the Republic of Korea (South Korea) by the Korea Food and Drug Administration (KFDA); in Australia by the Therapeutical Goods Administration (TGA); in South Africa by the Medicines Control Council (MCC); in Brazil by the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA); in Iran, India and Pakistanby the Ministry of Health;[3] and by similar national organisations worldwide. Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly; additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing.
Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(A) of the FD&C Act (21USC374), which requires that they are performed at a “reasonable time”. Courts have held that any time the firm is open for business is a reasonable time for an inspection.