Dr. Saunders number one priority is quality assurance. All of Dr. Danielle's products are mandated through the FDA via Good Manufacturing Practice (GMP) Guidelines. This means that:
1) Buildings and facilities used are designed properly to optimize clean and sanitary conditions.
2) Equipment is designed and maintained in a way to prevent corrosion, buildup of material, dirt or sanitizing agents. Equipment and utensils are cleaned and sanitized at appropriate intervals and protected in ways to prevent dust and other contamination.
3) Personnel are educated and trained in how to perform assigned functions, prevent adulterations of products, and are required to wear appropriate outer garments, hair restraints, gloves, etc and maintain adequate personal cleanliness.
4) Raw Materials are stored and handled in a way that prevents any mix-up, contamination with microorganisms or other chemicals, decomposition from exposure to excessive heat, cold, sunlight, moisture, and are securely closed and stored off the floor. Containers of materials are labeled with respect to identity, lot identification and control status. Materials are sampled and tested to assure the absence of contamination with microorganisms or other adulterations.
5) The Production process makes sure that all equipment, utensils, and containers used for holding raw material and bulk materials are in clean, good, and sanitary conditions. Only approved materials are used. To ensure quality, samples are taken and tested, as appropriate, during and/or after processing, transfer, or filling. Weighing and measuring of raw materials are checked by a second person, and containers holding the material are properly identified. In addition, labels are examined before labeling to avoid mix-up and the finished products bear permanent code marks regarding the equipment used for processing, holding, transferring, and filling of batch.
6) Laboratory controls are in place to assure that raw materials in samples and finished products are tested to verify their identity, determine their physical and chemical properties, as well as rule out any microbial, unwanted or hazardous contamination. Moreover, reserve samples are retained for the specified period of time and retested for continued compliance.
7) Records are kept of the raw and primary packaging materials, documenting any rejected materials. Manufacturing of batches document the kinds, lots, quantities of materials used, processing, handling, transferring, holding, filing, sampling, controlling, adjusting and reworking, code marks of batches and finished products.
These steps are enacted to assure quality to clients as well as guarantee to consumers that they are only ingesting what is listed on our labels. Quality and compliance is essential to Dr. Danielle personally and something taken very seriously. She takes pride in bettering her clients, clients health and well-being.
For more information and details on GMP guidelines please visit FDA’s website: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm#IV