Commissioning, Qualification & Validation

(CQV)

Efor led the commissioning and qualification (C&Q) of a new commercial antibody–drug-conjugate (ADC) manufacturing facility, providing end-to-end C&Q management, documentation and execution. Applying a risk-based approach aligned with ASTM E2500, our multidisciplinary teams brought grey utilities, HVAC systems, and waste-treatment online, and carried out the commissioning and qualification of clean utilities, cleaning-in-place (CIP) networks, cleanrooms, upstream and downstream process equipment, support and analytical devices, as well as temperature-mapped critical areas with optimized calibration programs. Using Kneat for fully paperless CQV, structured stage-gates and proactive issue tracking, we delivered a “right-first-time” start-up that met all regulatory expectations. Shift-work execution delivered a right-first-time start-up, on-schedule handover, and inspection-ready operations, de-risking launch and accelerating the client’s time-to-market.

Ensuring fully compliant facilities

Efor mobilized a multidisciplinary team of 40 professionals to support the delivery of a new sterile manufacturing facility for a global biopharma client. Our scope included comprehensive process package management and full, end-to-end Commissioning and Qualification (C&Q). A risk-based, compliance-driven approach aligned with industry standards was applied to plan and execute C&Q activities across HVAC and facility systems, black/grey and clean utilities, process equipment, and manufacturing support systems. Full lifecycle C&Q services were delivered, including documentation development, execution, and regulatory readiness. An integrated and proactively managed delivery model minimized rework, optimized cost and schedule adherence, and ensured the successful handover of a facility fully compliant with all applicable regulatory expectations.

Accelerating facility ramp-up through end-to-end asceptic compliance and data-integrity by design

Efor delivered a 14-month Commissioning, Qualification & Validation (CQV) program for a newly expanded sterile‐manufacturing site, focusing on environmental-monitoring and utility Quality Control (QC) instruments. Our multidisciplinary team implemented and validated new equipment and systems aligned with EU GMP Annex 15 and Annex 1 requirements, including change controls, URS, traceability matrices, risk and data-integrity assessments, authoring and executing qualification protocols (IQ/OQ/PQ), managing deviations, and issuing final release reports. The result: fully validated new equipment available in the QC laboratory that meets the latest EU GMP requirements, delivers traceable, data-integrity-proof results, and enables faster, “right-first-time” batch release for our client’s expanded manufacturing operations.

Optimising synergies through an on-site Service Centre

Efor created and now runs an on-site Validation Service Centre that consolidates fours critical programs, including process, thermal and cleaning validation with project/Autonomous Production Unit (APU) management for a large-scale vaccine campus. A diverse and complementary team, including a project manager, four coordinators and twenty specialised consultants, handles the entire cycle: validation of bulk vaccine manufacturing processes, formulation, and filling, Extractables and Leachables (E&L), validation of sterilization or autoclave and cleaning-in-place (CIP)/sterilization-in-place (SIP) processes, cleaning validation and system qualification for autonomous units. Within the first year we shifted to a deliverable-based model, pooling expertise, tightening schedules and simplifying resource use. The client in the pharmaceutical industry now has a single point of accountability and faster GMP compliance.