ADH’s processes meticulously adhere to Standard Operating Procedures (SOPs) that comply with the FDA’s Good Manufacturing Practices (GMPs). Our quality assurance practices begin with our ingredient suppliers, apply to all points in the manufacturing process, and culminate with finished product analysis and stability testing.
- 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.
- 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 conducted 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:
- Weight variation
- 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.
Finished Products QC
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.
- Composition – tests to determine the composition of a product
- 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