ICQ specializes in executing commissioning activities that are rigorously integrated with your own qualification activities, engineering procedures and quality systems.
We can also help you update current CQ&V Strategies to meet changing regulatory guidelines, or to bring your program into alignment with current industry practices.
At a number of manufacturing facilities, both large and small, ICQ consultants have been directly responsible for ensuring that appropriate standards were established and adhered to for all validation activities—PQ/PV, as well as CIP and SIP PQ.
Whether you need a little help with protocols and documentation, or a full-scale program that takes you from initial planning through execution and, ultimately, regulatory approval, we have the know-how and the people to get the job done effectively and efficiently.
In addition to our C&Q work, we often work closely with QA staff to evaluate quality procedures, develop and execute mitigation plans and create documentation and reporting systems that are efficient, reliable and consistently reproducible.
Intelligent, risk-based quality strategies grounded in ICH-Q9/ICH-Q10 and other regulatory guidelines are being used throughout the industry to ensure product safety and regulatory compliance, while maximizing operational efficiency.
Our Compliance Specialists have an in-depth understanding of manufacturing operations, processes and systems, and are expert in the latest regulatory directions and industry best practices. As a result, we’re able to help you apply a scientific quality risk management (QRM) approach at every stage of your process—from design of unit operations, to identifying critical inspection and testing points, to developing SOPs, training and documentation.