Our Comprehensive CQV Service Offerings

Decommissioning & Lifecycle End

System decommissioning requires the same rigor as commissioning to prevent cross-contamination and ensure environmental safety.

• System Decommissioning Plans: We develop protocols for safe and compliant removal of equipment and facilities, including scope definition, cleaning and purging procedures, and hazardous material handling.
• Decontamination & Cleaning Verification: We manage decontamination cycles to ensure systems are free of biological and chemical contaminants before dismantling. Surface sampling (swab/rinse) verifies cleaning effectiveness prior to equipment removal or disposal.
• Documentation & Data Archiving: We ensure that all historical validation documentation, calibration records, and maintenance logs for decommissioned systems are properly archived and retrievable for future regulatory inquiries, in compliance with record retention requirements.
• Traceability & Part Marking: We tag and document the removal of critical components to maintain an accurate audit trail and prevent re-use of decommissioned parts.

Qualification Services (IQ, OQ, PQ)

We execute qualification protocols that document correct installation, intended operation, and consistent performance under production conditions.

• Design Qualification (DQ): We review and approve engineering designs against User Requirement Specifications (URS) to ensure the system meets its intended purpose and regulatory requirements. This is the first step in demonstrating that quality is “designed in.”
• Installation Qualification (IQ): We verify and document that all system components are installed correctly by approved specifications, drawings, and vendor recommendations. This includes material verification, proper lubrication, and calibration of critical instruments.
• Operational Qualification (OQ): We test the system’s operating ranges and functions under controlled conditions. This includes testing alarms, interlocks, setpoints, and control system functionality across the entire operating range (e.g., low, normal, and high speeds/temperatures). We challenge the system to ensure it operates as intended at its extremes.
• Performance Qualification (PQ): We test the system under actual or simulated production conditions to demonstrate consistent performance with process requirements, such as maintaining temperature or proving aseptic filling line capability.

Equipment Qualification

We qualify all types of GxP-impacting equipment, from laboratory balances to large-scale production bioreactors.

• Process Equipment: Qualification of reactors, centrifuges, dryers, blenders, tablet presses, coating pans, filling lines, and lyophilizers.
• Analytical Instruments: We qualify laboratory equipment, including HPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, and balances, to ensure suitability for their intended use and to ensure reliable data generation.
• Storage Equipment: We qualify stability chambers, cold rooms (2-8°C), freezers (-20°C, -80°C), and incubators to ensure they maintain the required temperature conditions.
• Packaging & Labeling Equipment: We qualify blister packers, cartoners, case packers, and label applicators to ensure accuracy and prevent mix-ups.

Process Validation

We guide you through the full lifecycle of process validation, aligned with the FDA’s 2011 Guidance for Industry and the EU Annex 15.

• Stage 1: Process Design: We help define the manufacturing process based on development studies and scale-up activities, identify Critical Process Parameters (CPPs), and establish a control strategy using risk assessment tools such as Failure Mode Effects Analysis (FMEA).
• Stage 2: Process Qualification: We author and execute Process Performance Qualification (PPQ) protocols. We oversee the manufacture of conformance batches, analyze the data statistically, and author the final PPQ report that serves as the primary evidence that the process is capable of reproducible commercial manufacturing.
• Stage 3: Continued Process Verification (CPV): We help establish CPV programs to monitor process performance and product quality, set up statistical process control (SPC) charts, define alert and action limits, and conduct periodic reviews to ensure ongoing control.

Cleaning Validation

Preventing cross-contamination is a fundamental GMP requirement. Our cleaning validation services ensure your cleaning procedures are effective, robust, and defensible.

• Cleaning Validation Master Plan (CVMP): We develop a comprehensive CVMP outlining the strategy and approach for cleaning validation across your facility.
• Risk Assessment (Health-Based Limits): We conduct risk assessments to establish scientifically justified acceptance criteria for residues, including:
  • Acceptable Daily Exposure (ADE) / Permitted Daily Exposure (PDE): Calculation of health-based limits per ICH Q3C and Q3D guidelines, as well as EMA guidance on setting limits for cross-contamination.
  • Residue Limits: Calculation of maximum allowable carryover (MACO) of active ingredients and detergents.
• Protocol Development & Execution: We author and execute cleaning validation protocols for manual and automated Clean-in-Place (CIP) systems, including sampling strategy, analytical method selection, and recovery studies.
• Hold Time Studies: We design and execute studies to establish maximum hold times for equipment before and after cleaning.
• Continued Cleaning Verification: We help transition from traditional cleaning validation to continuous verification, using monitoring data to ensure ongoing control of the cleaning process.