Wise Woman Herbals
Good Manufacturing Practices
In the herbal and dietary supplement industry a new mantra "accountability" has ushered in the 21st century. Long before the release of the Food and Drug Administration’s published guidelines for current Good Manufacturing Practices in the latter half of 2007, it had not been uncommon to receive self-audit questionnaires from teaching institutions and practitioners and be inundated with inquiries about Wise Woman Herbals’ status in the realm of compliance with Good Manufacturing Practices.
Compliance and regulatory affairs is nothing new to our industry nor to our company. Herb safety has been regulated for many years by two federal agencies; The Food and drug Administration (FDA) oversees manufacturing and labeling compliance and the Federal Trade Commission (FTC) regulates advertising and marketing of herbal and dietary supplements.
Wise Woman Herbals ® has a long history of cGMP compliance that predates the release of current regulations and has also been actively involved in the process of assuring fair and just regulations. In 2003 we participated in the regional cGMP roundtable discussion hosted by the American Herbal Products Association (AHPA) to review the proposed guidelines and provide a unified voice debating aspects adopted from the pharmaceutical industry that were inconsistent with the way the herbal industry operates.
Now that final Good Manufacturing Practice guidelines are in place and accompanied by a firm time-line for attaining compliance, the landscape has changed for herbal and dietary supplement manufacturers. It is in the best interest of the industry and the public that manufacturers not delay in meeting the current standards and offer proof of cGMP compliance through an independent third party audit. Wise Woman Herbals has all of the key systems in place that are essential to achieving this goal, such as a Director of Quality Assurance along with a QA/QC team, Quality Control Lab for raw material and finished product identity and purity testing, written Standards of Procedure assuring consistency for every stage of the production process, a knowledgeable staff that is trained and skilled in cGMP’s, and facility and equipment sanitation and maintenance consistent with current regulations.
After years of preparation, in 2008 we earned the distinction as a leader in the herbal industry from achieving compliance verified by an independent 3rd party audit with the United States Food and Drug Administration ‘Good Manufacturing Practices’. We are further distinguished by Health Canada’s Site License approval and nearly 100 Natural Product and Submission Numbers by their Natural Health Products Directorate. These tremendous accomplishments are essential to our company’s future and vital to the herbal and dietary supplement industry. Wise Woman Herbals is achieving these monumental goals to better serve you while maintaining our core values of quality, purity, and the traditional hand-made processing techniques essential to our products.
WHAT SETS WISE WOMAN HERBALS APART:
• PROFESSIONAL PRODUCT LINE: Our distribution is tightly controlled and geared toward professionals. We do not market to retail stores and we will not sell to e-commerce based businesses. This assures that our products are recommended by well-informed health care providers, which protects the public, our customers and our brand.
• GOOD MANUFACTURING PRACTICES: We earned distinction for achieving cGMP compliance verified by independent 3rd party audit years in advance of FDA requirements. We maintain a full-time compliance and regulatory staff.
• RAW MATERIALS: We source from local growers using high quality organic, biodynamic, wildcrafted and cultivated herbs. We don’t use herbs treated with pesticides, that have been irradiated or altered from their natural state.
• TRADITION & SCIENCE: We combine traditional organoleptic technique along with state of the art Near Infrared Spectrophotometry (NIR) for verifying identity of raw material and finished product. We manufacture our products using a time-honored traditional maceration process in our cGMP compliant facility.
• SMALL BATCH SIZE: We continue to make frequent small handmade batches through traditional maceration process to assure active constituent viability and maintain high concentration and consistent quality.
• SHELF-LIFE STUDIES: We scientifically verify our “Best Used By” dates by testing for active constituent strength through ‘accelerated shelf-life studies’ using High Performance Liquid Chromatography (HPLC).
• QUALITY, CONSISTENCY & EFFICACY: As a result of small batch size, accelerated shelf-life studies, and cGMP compliance, we are better able to control consistency, strength & the viability of our products.
• SUSTAINABILITY: We offset 100% of our energy use by purchasing wind, biomass & solar energy for our Feng Shui designed facility. Our carbon footprint is minimized through composting, recycling, and using recycled packaging materials.