cGMP

Ameridose has moved its quality benchmark beyond USP <797> standards to meet cGMP (current Good Manufacturing Practices), addressing requirements of the FDA for control and management of pharmaceutical production.  Ameridose operates its manufacturing processes in accordance with cGMP requirements, thus guaranteeing products that are consistently properly identified, correct in strength, and superior in quality. We have raised the bar on quality to ensure that your patients receive the highest quality preparations.


cGMP Requirements                                  Ameridose Meets cGMP

Inbound Product Identity Verification	All materials used for our product are validated through a multi-step identity verification process.
A Product Library	A sample of each lot is retained for reference.
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 and routinely certified to comply with ISO 14644 requirements.  Preparations and documentation undergo a rigorous release process, including multi-step quality check.
Process Validation	Each process is tested for physical, chemical, and microbiological attributes against rigorous specifications.  Media fills are completed for each process on an on-going 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	Continuous testing and auditing of environment, people, and products.