Commissioning and qualification of pharmaceutical facilities
C&Q Services
Commissioning, Qualification and Validation (CQV)
Commissioning, Qualification and Validation (CQV)
We offer comprehensive commissioning and qualification of pharmaceutical facilities, along with validation services, to ensure that your facility meets all GEP and GMP requirements and industry standards. We work as an integral part of the project delivery throughout all phases, as well as on a consultant basis, to support your projects or regular production.
Our team of experts in pharmaceutical commissioning and qualification provides a full range of services, including leading and executing design qualification, commissioning, installation, operational and performance qualification, as well as a wide variety of validation services, such as cleaning, sterile, aseptic, and process validation. We also have extensive experience in the qualification and validation of automated and computerized systems.
Our training and background in design and executin of capital projects give us a practical, solution-focused approach, and an ability to ensure pharmaceutical manufacturing compliance while seeing projects through from beginning to end.
Pharmaceutical manufacturing compliance
Meeting industry standards is critical to your success. At KeyPlants, we provide expert commissioning and qualification services to ensure your facility operates efficiently and complies with GMP and regulatory requirements.
With a focus on quality and precision, we guide you through every phase, from design qualification to operational readiness. Whether building a new facility or optimizing an existing one, KeyPlants is your trusted partner in pharmaceutical manufacturing compliance.
Comprehensive support for compliance & validation
At KeyPlants, we specialize in providing seamless support for commissioning, qualification, and validation services tailored to the pharmaceutical industry. From initial design phases to operational readiness, our expertise ensures that your facility meets all regulatory requirements with precision and efficiency.
With a practical and hands-on approach, we focus on delivering results that align with your project goals while ensuring compliance at every stage. Whether validating existing systems or commissioning new facilities, KeyPlants is committed to helping you achieve excellence in pharmaceutical manufacturing compliance.
Quality Assurance (QA)
Quality Assurance (QA)
Our Quality Assurance team will support you, both in projects and regular production. We will work in line with your existing quality system, or we can help develop or expand your quality system to ensure compliance with current regulations. Our comprehensive QA services are a complement to our Commissioning, Qualification, and Validation (CQV) services, ensuring seamless integration and regulatory compliance across your facility.
The QA team is backed by an organization with worldwide experience in pharmaceutical facility projects. They are trained to see the full picture as well as make difficult decisions. Their experience in pharmaceutical design and construction also gives them a practical, solution-focused approach, and an ability to see projects through from beginning to end.
We pride ourselves on tailoring our quality assurance strategies to each project, addressing specific regulatory needs while ensuring operational efficiency. Whether supporting a new build or optimizing existing processes, our QA services are aligned with your broader project goals. To explore more about our approach to quality, visit our design services page to see how we deliver excellence in pharmaceutical engineering.
FAQ
FAQ
What are commissioning and qualification (C&Q) services?
Commissioning and qualification (C&Q) services ensure that pharmaceutical facilities, equipment, and systems meet GMP and regulatory standards. These services validate that all processes function as intended before production begins.
Why are C&Q services critical for pharmaceutical facilities?
C&Q services are essential to ensure compliance with regulatory requirements, optimize operational performance, and guarantee product quality. They help identify and resolve potential issues during the early stages of project execution.
What does KeyPlants offer in its C&Q services?
KeyPlants provides comprehensive C&Q services, including design qualification, installation qualification, operational qualification, and performance qualification. Our team ensures every aspect of your facility meets the highest industry standards.
Can C&Q services be integrated into ongoing operations?
Yes, KeyPlants specializes in offering C&Q services that seamlessly integrate into both new builds and existing facilities, ensuring minimal disruption to operations while maintaining compliance and efficiency.
How does KeyPlants handle regulatory requirements in C&Q?
Our team has extensive experience navigating GMP and global regulatory frameworks. We ensure every step of the C&Q process aligns with compliance standards, giving you confidence in your facility’s readiness.
Our team has extensive experience navigating GMP and global regulatory frameworks. We ensure every step of the C&Q process aligns with compliance standards, giving you confidence in your facility’s readiness.
Our Projects
“Having everything delivered from Sweden based on key, proven, core technologies is definitely an advantage in getting to market fast.”
“We are proud of our new state-of-the-art modular production facility that enables us to meet our increasing sales volumes. To add this modular building to our existing production building in a limited available space was a great challenge, but nevertheless a successful achievement.”
"We chose KeyPlants for three main reasons. Firstly, KeyPlants is known for its turnkey modular solutions within life science. Their modular concept allows us to build our new facility in stages, which gives us important flexibility. Secondly, KeyPlants showed us that they have recently finished similar projects. They have good references. The third reason is that Key Plants has production in Sweden. This minimises transportation risks and makes communication fast and smooth."
