More about our QA Practices
Sutter Pharmacy requires that all suppliers of dietary supplements and homeopathic medicines verify their quality assurance practices according to our Vendor Quality Assurance Practice Standards (VQAP). Verification can be done through an on-site audit done by Sutter Pharmacy staff, or proof that an independent third party cGMP program has audited the manufacturer in the last 12 months. Re-verification is necessary every three to five years, depending on VQAP compliance.
- Verification can be done through an on-site audit done by Sutter Pharmacy staff, or proof that an independent third party cGMP program has audited the manufacturer in the last 12 months.
- Re-verification is necessary every three to five years, depending on VQAP compliance.
Audits assess the following:- Identity for all raw materials via in-house or qualified laboratory testing
- In-house, qualified laboratory or validated supplier Certificate of Analysis for:
- identity, microbiological and heavy metal contaminants (NSF, USP or AHPA limits)
- pesticides/herbicides (for applicable botanicals)
- aflatoxins (when applicable)
- melamine (when applicable)
- potency (when applicable)
- Use of most appropriate testing methodologies when testing for identity, microbiologicals, heavy metals, pesticides/herbicides (for botanicals), aflatoxins, melamine and residual solvents
- All methodologies will be compendia methods and/or scientifically valid methods
- Acceptable supplier and contract manufacturer qualification consisting of:
- demonstrated cGMP compliance
- on-site audit or established historical relationship
- initial validation of certificate of analyses (CoA) for raw ingredients.
- In addition to supplier CoA, identity is tested on each batch of raw materials or finished product and all other analytical tests [microbiology, heavy metals, pesticides/herbicides (non-organic), solvents (concentrates)] are completed on at least every fifth batch/lot or, if less than 5 lots, at least once annually. Potency-testing procedure for finished products in place and in use
- Evident knowledge of industry-known common adulterants and contaminants, and sufficient testing to guarantee the absence of these adulterants and contaminants in finished products by conducting full confirmation testing
- SOP demonstration of controlled manufacturing processes for all finished products
- Specifications for all raw material and finished products and documented usage of these specifications
- A stability program is in use to ensure that all finished products meet label claim throughout their shelf life
- Products contain active ingredients in sufficient quantities to be clinically effective
- Evidence of total quality (e.g. research and product development, product formulation, sustainable environmental practices, clinical trial support, good business practices)
Sutter Pharmacy also places a strong emphasis on professional-quality supplements from vendors who are known throughout the industry for their standards for purity, quality and efficacy. These manufacturers include:
- Integrative Therapeutics, Inc.
- Metagenics
- Seroyal/Pharmax
- Pure Encapsulations
- Thorne Research
- Vital Nutrients