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Quality Assurance

Micron Technologies has a Quality Assurance Group(QA) -located at each facility dedicated to ensuring the highest quality of services. QA oversees the review of batch manufacturing records (BMR); analytical data review, ensures employee training is current and complete and ensures procedures are fully documented. 

Audits

An average of four client audits a month helps ensure Micron continues to make improvements, supporting the changing pharmaceutical quality environment and the needs of clients.

Micron also conducts internal cross auditing to ensure the same level of quality from each facility.

100% Cleaning Verification

Micron Technologies operates under a 100% cleaning verification approach for release of all milling equipment. Prior to any material being processed, cleaning recovery studies are conducted using HPLC analysis as the detection method. The allowable residual level of a drug substance can change based on the toxicity or dose of the following drug. Quality Assurance performs a calculation looking at toxicity data and dosing data, compares this to the lab analysis and releases the milling equipment based upon this data, if suitable. 100% of the product contact surfaces of the mill are swabbed.

No penicillin, beta lactams, or cephalosporin are accepted.

Regulatory

Micron works closely with their clients to ensure all requirements are met. Micron has been inspected by the FDA, MHRA, PMDA and DEA (US Only). Micron continues to work to ensure compliance with all applicable regulations. With the support of the corporate organization, regulatory trends in any region of the world are quickly identified.

Inspection History