CQV – Your partner for end-to-end, integrated, digital CQV services
At MMR, CQV is one of our core Centers of Excellence, we live and breath CQV every day, it is part of our DNA. We have experience with end-to-end CQV, from implementing systems/procedures/VMPs through to fully executing projects. Our CQV experience spans existing facilities, re-qualifications, remediations, projects/improvements, as well as greenfield & brownfield expansions & new facilities. Our methodology ensures full compliance with industry regulations, delivering solutions that uphold the highest standards of quality and safety.
Front End CQV Planning
- Development of Procedures, Templates, Processes, VMPs (or modernization of current systems to latest industry guidelines & best practices)
- Project Level Planning: Development CQV Plan, Schedule, Org Chart/Resourcing, Budget, Deliverables
- Early CQV Execution: Development of deliverables for vendors & CMs. Preparation of C&Q General Specification & VDR/TOP Matrix to be included with RFPs, evaluation for vendor proposals for CQV requirements.
Our team of seasoned professionals brings extensive experience and technical expertise across all phases of the C&Q lifecycle. We employ a risk-based methodology, while utilizing industry best practices, Digital Systems (E-Validation, ETOPs, etc…), incorporating Good Engineering Practices (GEP), regulatory expectations, and industry standards such as ISPE Baseline, ICH, GAMP5, and Eudralex guidelines to ensure an efficient and compliant process.
C&Q Services
- Equipment: Process, Packaging
- Utility & Facilities: Dirty Utilities, Clean Utilities, Facility
- Laboratory: Turnkey lab C&Q from the equipment, utilities, through to the computerized systems, lab informatics, software and IT infrastructure.
- Temperature Mapping: MMR can provide Thermal/Sterilization Equipment.
- Automation Systems Qualification: Process Automation/IT/OT (PCS/DCS/SCADA/Historians/MES/IT Infrastructure) and Buildings Automation (GMP & Non-GMP BAS, EMS)
- PQs: Equipment/Recipe PQs, EMPQs, Utility PQs
- Approach: MMR utilizes integrated risk based approaches such as ASTM E2500, ISPE ICQ, or MMR’s Lean C&Q Approach, to focus on critical aspects and critical systems that affect product quality and patient safety. These risk-based methods emphasize testing key systems while minimizing effort on non-essential areas.
Validation Services
- Cleaning Validation
- Process Validation
- Thermal & Sterilization Validation, including Temperature Mapping; MMR can provide the thermal validation equipment for Temperature Mapping
- Computer System Validation
- Experience with CQV project execution with the use of paperless validation software
- Serialization system validation
- Aseptic PQs / Media Fills
- Process PQs (PPQs) / Licensure Batches
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- Regulatory Compliance: Our team is highly knowledgeable in global regulatory requirements, including those from the FDA, EMA, Health Canada, EU, JP, and other key authorities. We ensure complete and accurate documentation and validation reports, facilitating smooth regulatory audits and inspections.
- C&Q Project Management: From C&Q Strategy and Planning, through to management of entire CQV project execution.
- Paperless Validation: MMR specializes in digital validation, from deploying / configuring / validating the software, training projects teams how to utilize the software, through to utilizing the software on large projects. Additionally, MMR maintains its own instance of KNEAT, enabling us to deliver seamless, end-to-end paperless validation support for our clients
By leveraging our deep technical expertise, risk-based methodology, and unwavering commitment to regulatory compliance, MMR effectively addresses key challenges in the commissioning and qualification (C&Q) process. This approach ensures the successful execution of C&Q projects, enhancing operational efficiency while safeguarding product quality.