GMP Pros
GMP Pros is a specialized engineering and technical consulting firm focused on FDA-regulated manufacturing excellence. Since 2013, we’ve been helping pharmaceutical, biologics, food, and animal health manufacturers enhance capacity, efficiency, and quality through our embedded “boots on the ground” approach. We help teams optimize operations through digital transformation, process engineering, and compliance excellence, aiming to bring new ideas and improvements to the world—finding A Better Way for Everything™. Our expertise includes MES (Manufacturing Execution System) and MES historian implementation, validation, system integration, and continuous improvement strategies tailored for regulated manufacturing environments.
Industries
Nr. of Employees
small (1-50)
GMP Pros
Products
food beverage
Deployment of automation systems and consulting services that enhance food safety, improve quality consistency, increase production efficiency, and ensure FSMA and GFSI compliance.
Food and Beverage Project Management Consulting
Specialized project management expertise in FSMA compliance, SQF certification, and production scaling to navigate FDA regulations and optimize manufacturing facilities.
Regulated Manufacturing Process Automation Consulting
Compliant automation solutions and consulting for pharmaceutical, biotech, and medical device manufacturing maintaining FDA 21 CFR Part 11 and GAMP 5 compliance.
Pharma Process Automation Consulting
Comprehensive consulting service for pharmaceutical manufacturing automation, implementing FDA-compliant automation to reduce batch cycle time while ensuring cGMP compliance.
MES/Electronic Batch Records Implementation
Implementation services for Manufacturing Execution Systems and Electronic Batch Records tailored for pharmaceutical and regulated manufacturing facilities.
MES and eBR Deployment Services
Practical execution, deployment support, and change management services for manufacturing execution systems (MES) and electronic batch records (eBR).
food beverage
Deployment of automation systems and consulting services that enhance food safety, improve quality consistency, increase production efficiency, and ensure FSMA and GFSI compliance.
Food and Beverage Project Management Consulting
Specialized project management expertise in FSMA compliance, SQF certification, and production scaling to navigate FDA regulations and optimize manufacturing facilities.
Regulated Manufacturing Process Automation Consulting
Compliant automation solutions and consulting for pharmaceutical, biotech, and medical device manufacturing maintaining FDA 21 CFR Part 11 and GAMP 5 compliance.
Pharma Process Automation Consulting
Comprehensive consulting service for pharmaceutical manufacturing automation, implementing FDA-compliant automation to reduce batch cycle time while ensuring cGMP compliance.
MES/Electronic Batch Records Implementation
Implementation services for Manufacturing Execution Systems and Electronic Batch Records tailored for pharmaceutical and regulated manufacturing facilities.
MES and eBR Deployment Services
Practical execution, deployment support, and change management services for manufacturing execution systems (MES) and electronic batch records (eBR).
Services
Assessment, selection, integration, validation, and deployment of electronic batch record solutions with automated data capture, audit trails, and electronic signature controls for regulated manufacturing.
Full-lifecycle MES and historian services covering requirements definition, architecture and infrastructure planning (including cloud/hybrid options), integration with enterprise and control systems, historian sizing and retention planning, validation planning, and phased deployment.
On-site engineering teams to support production engineering, equipment commissioning, capital projects, and start-up activities including execution of IQ/OQ/PQ/IOPQ protocols and knowledge transfer to operations.
Custom data-science solutions including NLP for legacy database search, analytics for downtime reduction, anomaly detection models, and integration with existing systems to extend value of historical data.
Design and deployment of data quality programs, metric definitions, monitoring tools, operational reporting, and validated migration procedures to ensure data integrity across batch records and production systems.
Process optimization engagements using centerlining, SOP and master setup sheet development, hands-on data collection, and training to reduce changeover, increase OEE, and standardize operations.
Assessment, selection, integration, validation, and deployment of electronic batch record solutions with automated data capture, audit trails, and electronic signature controls for regulated manufacturing.
Full-lifecycle MES and historian services covering requirements definition, architecture and infrastructure planning (including cloud/hybrid options), integration with enterprise and control systems, historian sizing and retention planning, validation planning, and phased deployment.
On-site engineering teams to support production engineering, equipment commissioning, capital projects, and start-up activities including execution of IQ/OQ/PQ/IOPQ protocols and knowledge transfer to operations.
Custom data-science solutions including NLP for legacy database search, analytics for downtime reduction, anomaly detection models, and integration with existing systems to extend value of historical data.
Design and deployment of data quality programs, metric definitions, monitoring tools, operational reporting, and validated migration procedures to ensure data integrity across batch records and production systems.
Process optimization engagements using centerlining, SOP and master setup sheet development, hands-on data collection, and training to reduce changeover, increase OEE, and standardize operations.
Expertise Areas
- MES and historian implementation for regulated manufacturing
- Electronic batch record systems and digital batch documentation
- Data quality monitoring, data migration, and manufacturing analytics
- Regulatory validation and compliance for GxP computerized systems
Key Technologies
- Manufacturing Execution Systems (MES)
- Historian / time-series data systems
- Electronic batch record systems (EBR)
- ERP / LIMS / WMS integration
News & Updates
A case study on how standardizing machine settings and optimizing processes increased overall equipment effectiveness by 38%.
A case study on how electronic batch record systems improved compliance and reduced errors.
A case study on how NLP software integration reduced downtime by 18% and decreased after-hours calls by 90%.
An overview of key manufacturing best practices for 2024, including process optimization, technology integration, sustainability, workforce empowerment, and quality assurance.
A detailed guide on how to measure manufacturing efficiency using KPIs, formulas, and best practices.
An article explaining the importance of manufacturing efficiency, how to calculate it, and steps to improve it.
A case study on how standardizing machine settings and optimizing processes increased overall equipment effectiveness by 38%.
A case study on how electronic batch record systems improved compliance and reduced errors.
A case study on how NLP software integration reduced downtime by 18% and decreased after-hours calls by 90%.
An overview of key manufacturing best practices for 2024, including process optimization, technology integration, sustainability, workforce empowerment, and quality assurance.
A detailed guide on how to measure manufacturing efficiency using KPIs, formulas, and best practices.
An article explaining the importance of manufacturing efficiency, how to calculate it, and steps to improve it.