Compliance Team has a wealth of experience when it comes to Pharmaceutical and Medical Device Consulting for clients in the pharmaceutical, biopharmaceutical, and medical device industries, and the government sector. As regulations, standards and guidance have evolved; we keep our teams current and adjust our approach to keep our clients compliant.
Our teams deliver the highest quality pharmaceutical and medical device consulting by offering commissioning, qualification, and validation documents for facility systems (including HVAC equipment), equipment systems, utility systems, and computer / control systems. Our support helps ensure the safe and efficient start-up of new facilities and changes to existing facilities required for expansion of existing production capacity.
Our teams support each client’s engineering and quality organizations by developing commissioning and validation documents, such as, validation plans, user requirement specifications, functional requirement specifications, design qualification, commissioning test plans, system impact assessments, component impact assessments, factory acceptance tests, installation qualification, operational qualification, performance qualification, process validation, etc., as needed for meeting today’s engineering best practices.
We have a diverse base of experience in developing protocols and executing commissioning and qualification activities for our client’s projects associated with many different types of products (medical devices, pharmaceutical, and biopharmaceutical) and including today’s most complex technologies and process and utility system equipment and controls. The documents prepared include:
- Commissioning Plans
- Validation Plans
- HVAC Qualification Protocols
- Environmental Monitoring Performance Qualification Protocols
- Facility Qualification Protocols (i.e., API, Aseptic, Sterile, OSD, Warehouse, Cleanrooms, Radio-Pharmaceutical, Biopharmaceutical, etc.)
- Utility Qualification Protocols (WFI, RO/DI/Purified Water, Pure/Clean Steam, Clean Compressed Air, Nitrogen, etc.)
- Equipment Qualification Protocols (Aseptic Systems, OSD, Sterilizers, Fillers, Lyophilizers, Bioreactors, Autoclaves, Packaging Lines, CIP, SIP, etc.)
Compliance Team differentiates the quality and value of our services by staying current with today’s best practices and international regulatory expectations for commissioning, qualification, and validation. Our involvement in the ISPE community provides us with great perspective and insight into strategies for implementing practical and compliant solutions pertaining to commissioning and facility qualification, equipment qualification, and utility qualification consistent with the evolving harmonized regulatory framework around risk-based and science-based approaches to regulatory compliance.
Compliance Team provides practical solutions based on ASTM E2500-07 that improves the engineering process and delivers a more cost-controlled, efficient project in compliance with current regulatory requirements and expectations. Our solutions apply the concepts and principles introduced in the FDA’s document titled ‘Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach’, and in the ICH Q8, ICH Q9, and ICH Q10 documents.
We are ready to share our teams’ experience in delivering cost-effective and practical solutions to your organization. We will support your commissioning and qualification requirements and the on-time delivery of your critical projects to help meet your business objectives.