The success of a company's strategic plan to introduce a new product, transfer or expand manufacturing capacity or build a new facility is an arduous and daunting task - tight timelines, even tighter budgets, stringent quality standards and validation procedures, the need to be innovative.
Pharmaceutical manufacturers face a host of operational parameters requiring compliance including international regulations, faster time-to-market and flexibility/adaptability coupled with the demand for consumer protection and product safety, quality, identity, purity and potency. These elements are stretching the fabric of technology and have generated a new awareness of the necessity and importance of compliance in manufacturing operations and the need to integrate disparate data streams from your supply chain, enterprise resource planning (ERP), laboratory information management and plant-floor manufacturing execution systems.
To meet these challenges, our team of experienced manufacturing personnel can assist you with validating your equipment, facilities, utilities and systems from the front office to the plant floor. Our successful track record includes hundreds of projects delivered on-time and within budget across finished pharmaceutical bulk manufacturing, Active Pharmaceutical Ingredients (APIs), clinical trials investigational medicinal product manufacturing, packaging & labeling, biologics and solid dosage forms, ISO- 7 & 8 cleanroom validation, cleaning validation, environmental monitoring prgrams and temperature controlled equipment and related areas of pharmaceutical manufacturing.
Specialty services include development and execution of :
- Facility Master Validation Plan
- User Requirements Specifications
- Functional requirements Specifications
- Detailed Design Specifications
- Design Review & Design Qualification
- Equipment Selection & Supplier Qualification
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- IQ/OQ/PQ Development & Execution
- Temperature and Humidity uniformity mapping; differential pressure and particulate testing
- Bi-directional traceability of requirements to design & testing to demonstrate complete test coverage
- Validation Summary Reporting and commissioning
- Best practices SOPs for maintaining the validated state of compliance including change control and periodic reviews
- Pivotal clinical, Validation and Bio-batches & FDA pre-approval inspection readiness audits
- GMP, DEA and MHRA facility pre-commissioning and licensing audits
Our experienced team of specialists can assist you in the evaluation of the roles of equipment, people, materials, documents and existing information. Benchmarking current or planned workflow through Six Sigma and Lean Manufacturing techniques with applied tools such as fishbone diagrams and value stream maps will identify opportunities to eliminate non-value added activities and gain efficiency.
From the factory floor where shop floor data collection terminals transmit production data through supervisory control and data acquisition (SCADA) systems through real-time instruction to programmable logic devices (PLCs) to equipment, facilities and utilities qualification, USDM can provide planning, design, construction, project management, qualification, validation and commissioning of pharmaceutical, biotechnology or medical device manufacturing facilities, equipment, systems, utilities, processes, laboratory & test instrumentation and computerized systems to support full product development from conception to commercialization.
USDM are domain experts providing professional services that meet regulatory and business demands in compliance with current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEPs), Good Laboratory Practices (GLPs), ISO standards and Instrument Society of America (ISA) Standard S88/S95, batch production standards.
Call us today, and tomorrow we'll put market-leading manufacturing automation compliance solutions in the palm of your hand.
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
