Unsurpassed Assurance, Verification and Regulatory Support

Quality Assurance

Micron Technologies has a separate Quality Assurance Group located at both plants. Each group oversees every facet of the business that could impact product quality. Procedures are fully documented, updated and reviewed on an annual basis. Internal audits are conducted every month and external service providers are audited every 2 years. All batch manufacturing records (BMR) and analytical data receive 100% QA review. Training for ongoing improvement and annual GMP training is conducted by QA.

100% Cleaning Verification

Micron Technologies operates under a 100% cleaning verification protocol. Prior to any material being processed, cleaning recovery studies are conducted on stainless steel coupons, using HPLC analysis as the detection method. The residual level of a drug substance can change based on the toxicity or dose of the following drug. Quality Assurance does a calculation, compares this to the lab analysis and then releases the equipment if the data is suitable. All product contact surfaces are swabbed. No penicillin, beta lactams or cephalosporins are accepted.

Regulatory Status

Both facilities operate under the same global systems, have a Type 2 DMF and have been audited by the appropriate regulatory authorities. Both facilities average four customer audits per month and have a cross auditing program in place. With support of the corporate organization any regulatory trends in any region of the world are quickly identified.