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 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, clinical trials investigational medicinal product manufacturing, packaging & labelling, biologics and solid dosage forms, ISO- 7 & 8 cleanroom validation, cleaning validation and temperature controlled equipment and related areas of pharmaceutical manufacturing.
The USDM Life Sciences Manufacturing Systems practice focuses on rapid deployment, improved quality and reduced / risk-based validations for all of our engagements. We achieve this through:
- Experience – a decade of experience qualifying and validating manufacturing equipment and control systems.
- Risk-based approach to qualification and validation – a tried and tested method where the focus of the effort is on critical functions and modules that impact compliance data. All other functions that indirectly affect compliance data are minimally tested. This is documented in a detailed Risk Assessment.
- Validation Accelerator Packs (VAPs) for most standard manufacturing systems. These VAPs are a complete set of content-rich validation document templates for the system based on common, core requirements for life science manufacturers.
The VAP difference:
Each VAP lists requirements and tests for core and common system functionality and can be leveraged to build the validation documentation suite. The USDM VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance. Our VAPs include:
- Facility Master Validation Plan
- User Requirements Specification
- Functional Requirements Specification
- Detailed Design Specification
- 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
- Validation batch & FDA pre-approval inspection readiness audits
- GMP facility pre-commissioning audits
USDM Life Sciences works closely with its partners and vendors to identify upcoming patches and updates, and provides a full maintenance program for our Manufacturing Systems VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
USDM Life Sciences has a dedicated, experienced validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.
Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of Manufacturing Systems validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.
USDM Life Sciences has been successful across many Manufacturing Systems validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.