cGMP


Ameridose goes beyond USP <797> standards to meet cGMP (current Good Manufacturing Practices). Ameridose operates its manufacturing processes in accordance with cGMP requirements, thus ensuring products that are consistently produced to meet the same identification, strength, and quality specifications. We have raised the bar for compounding to ensure that your patients receive the highest quality preparations.

cGMP Requirements Ameridose Meets cGMP
Inbound Product Identity Verification All materials used for our products are validated through a multi-step identity verification process that includes Certificate of Analysis from original manufacturer, product ID testing, quarantine and release.
Reserve Sample Library A sample for each lot is retained for reference as required by cGMP.
Real-time Stability Testing Stability testing is done through FDA-registered third-party laboratories, evaluating extensive criteria including potency, sterility, pH, particulate matter, etc.
Rigid Controls Clean rooms and hoods are monitored 24/7/365 and routinely certified to comply with ISO 14644 requirements. Preparations and documentation undergo a rigorous release process, including multi-step quality check by a registered pharmacist.
Process Validation Each process is tested for physical, chemical, and microbiological attributes against rigorous specifications. Media-fills are completed for each process on an ongoing basis to ensure proper aseptic controls.
Product Verification Products are tested throughout their life-cycle to verify physical, chemical, and microbiological attributes.
End-product Testing Our end-product testing program ensures the highest product quality.
Continuous Audits Ameridose conducts continuous testing and auditing of environment, people, and products.

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