Good Manufacturing Practice

We conduct comprehensive feasibility studies to assess the technical, regulatory, and operational viability of your project. This can include indicative costings or order of magnitude costings to support your outline business case. Our approach identifies potential challenges early, evaluates options, and provides clear recommendations to support informed decision-making and successful project delivery.

Feasibility designs are used for different outputs. These can include snapshot views (short duration specification, process definition costings and timelines), data for site search and selection, review of existing facilities (within company, external to company).

We collaborate with stakeholders to define the process, regulatory, and operational needs of the facility, ensuring alignment between scientific requirements, business objectives, and regulatory requirements and GMP best practices. Our expertise helps clients develop robust URBs that support investment decisions, risk management, and facility feasibility studies.

Our Quality Risk Assessments (QRAs) follow ICH Q9 principles to systematically identify, evaluate, and mitigate risks to product quality and patient safety. We help you prioritise actions and implement controls that are proportionate, effective, and aligned with regulatory expectations. We can assist with risk mitigation on your process or facility.

We provide expert technical advice across all stages of your project lifecycle – from concept through to operational qualification. Whether you need input on cleanroom design, equipment selection, or compliance strategies, our team offers practical, experience-based guidance tailored to your needs.

Our design review services ensure your facility, systems, and equipment meet both user requirements and regulatory standards. We support you through design development, drawing reviews, and technical evaluations, helping to optimise layouts, workflows, and compliance from the ground up.

We provide comprehensive support across the full validation lifecycle, ensuring documentation is robust, traceable, and aligned with regulatory expectations. Our services include the generation, development, and review of key validation documents, including client and vendor generated documents, such as:

• Quality Technical Agreement (QTA) including Roles & Responsibilities (R&R)
• Validation Master Plan (VMP) and Validation Plans (VPs)
• User Requirements Specifications (URSs)
• Design Qualifications (DQs) with Requirement Traceability Matrix (RTM)
• Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
• Installation and Operational Qualification Wraparound (IOQW)
• Validation Summary Reports

Our primary objective is to enable the end-user team to maintain their focus on their core responsibilities, while CCTech oversees and manages the validation processes to ensure everything remains under control. Ensuring the timely delivery and operational readiness of a GMP-compliant facility.

We produce high-quality compliant documentation tailored to your systems and processes and also offer detailed review and feedback on documents supplied by clients, specialist subcontractors, or vendors. This ensures consistency, compliance, and clarity across all validation deliverables, supporting successful audits and inspections.

We provide expert guidance and support in managing vendor relationships to ensure technical alignment, documentation quality, and compliance with project and regulatory requirements. CCTech is committed to supporting contractors by providing comprehensive initial information necessary for accurate quoting and effective project planning.

Our services include:

• Vendor and Contractor Selection: We assist in identifying and evaluating suitable main contractors, specialist subcontractors, and equipment vendors based on technical capability and previous project experience to ensure deliverables meet user and regulatory expectations.
• Quality Oversight: Support in reviewing tender and bid proposals and technical submissions to ensure they meet the defined scope, standards, and performance criteria.

Our goal is to ensure that all third-party contributions support successful delivery and long-term operational reliability. Quality is critical throughout all aspects of our projects.