Quality control begins outside of our facility in establishing approved raw ingredient suppliers. Once identified, the testing protocol is not complete until the finished product has been subjected to our in-house lab testing. Quite simply, raw materials must meet our required specifications or they are rejected.
Supplier Qualification
- Ingredient suppliers’ facilities & procedures are routinely audited by our QA personnel.
- Upon receipt, raw materials are placed in quarantine, until they are sampled to test for purity, assayed for potency, and checked for identity.
In-Process QC
- After raw materials are released, in-process checks are conducted at every stage of the manufacturing process to ensure consistent quality. All product-facing surfaces are sanitized prior to use through validated cleaning methods to eliminate the risk of contaminants.
- Blending (powders & liquids) — Specialized sanitization of equipment is utilized to not only eliminate contaminants, but also to detect and remove traces of allergens.
- Compression and Encapsulation. A variety of physical and chemical test are conducted during set-up, and at regular intervals while batch is being produced. Depending on the dosage, the following tests are conducted:
- Disintegration
- Weight variation
- Thickness
- Friability
- Metal detection
- Coating. Tablets and capsules are sampled for weight variation prior to, during, and after coating.
- Packaging lines (solid doses, liquids, powders). In-process samples are tested for fill criteria, torque parameters (closures), aesthetics, and microbial contamination.
Finished Product Testing
All finished products are tested for:
- Purity — tests that detect the presence of contaminants, such as microbes and heavy metals.
- Strength —assays to establish the potency of active ingredients using validated methods.
- Physical criteria — tests to assess the physical quality of a product, such as disintegration time, hardness, and weight variation
Specialized tests are conducted as needed, such as
- Dissolution for extended/modified release formulations
- Stability tests — accelerated and real-time