More about our Quality Assurance Practices
Pharmaca requires that all suppliers of dietary supplements and homeopathic medicines verif y their quality assurance practices according to our Vendor Quality Assurance Practice Standards (VQAP). Verification can be done through an on-site audit done by Pharmaca 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 Pharmaca 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)
Pharmaca 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.
- Pure Encapsulations
- Thorne Research
- Vital Nutrients