Our staff have extensive compliance experience in a variety of cGMP environments.
GMP Compliance Expertise
- Data integrity audits and assessments
- GMP audit readiness, inspections and remediation
- GMP GAP Assessment
- Quality Systems review
- SOP Creation
- Training
- Calibration program audit and remediation
- Prepare Site Master File
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Fujifilm Diosynth Biotechnologies has utilized MMR Engineering at our two US Manufacturing facilities in North Carolina and Texas due to their expertise in Cytiva’s proprietary Unicorn software and Emerson’s DeltaV platform. MMR Engineering was prompt in delivering their proposal, accepting the awarded project and mobilizing their staff on site. Their personnel worked efficiently and strategically within our Automation, Quality Assurance and Validation Departments to deliver a qualified processing system on time and within budget. Their executed protocols were done right the first time all while meeting our stringent cGMP requirements such as adherence to SOPs and training, obtaining access to numerous qualified, electronic systems and supporting change control. MMR Engineering continues to provide Validation and Automation support to both sites at the present time and in the foreseeable future.
MMR’s team has shown great expertise in Clean Utilities when delivering a Global Engineering Guidance project for AbbVie on high purity water systems. Their persistence to meet timelines and deliver projects within tight schedules is also unique. MMR’s technical aptitude and project delivery was instrumental to the successful delivery of our projects, I would highly recommend MMR for Clean Utilities engineering projects.
MMR Consulting has demonstrated a profound technical knowledge in clean utilities and other process support systems / utilities, as well as a very unique project delivery model. Their creativity to figure out the real problem and determine a practical solution within a client’s constraints, as well as deliver a project within tight timelines and variable expectations, coped with their technical knowledge, engineering and commissioning skills makes them an exceptional consulting partner. I am fortunate to have worked with MMR on several projects, and would highly recommend them for either technical staff augmentation, or design and commissioning projects, with a specializing in Clean Utilities and Process.
MMR was contracted to support two high priority projects within our Toronto manufacturing facility: one focusing on chromatography skid upgrades and another on CIP process improvements.
MMR’s management of the two system upgrades was achieved in 9 months, from inception to completion. Further, the actual execution of engineering and IOQ was done during a shutdown period within 6 weeks. The CIP systems were turned over on time without impacting production.