20 years of CQV success

Pharmaceutical, Biotechnology, and Life Sciences industries necessitate high-standard Commissioning, Qualification, and Validation (CQV) as prescribed by industry guidance and regulations. CQV produces documented evidence, ensuring consistent and quality results. Adamson Pharma offers an integrated project approach based on the ISPE Baseline Guide Volume 5: Commissioning and Qualification, 2nd Edition, which includes ASTM E2500 and ICH Q9 principles. This approach saves cost and time while meeting regulatory expectations.

To address evolving regulatory requirements and the need for efficient CQV activities, Adamson Pharma focuses on optimised planning and deploying skilled CQV resources. They provide services such as audit preparation, cost and timeline estimates, ongoing CQV support, and assistance with audit remediation, deviations, CAPAs, and FMEAs.

Typical Qualification Lifecycle


Our expertise in C&Q delivery stems from time served experience with the following pharmaceutical and quality engineering manufacturing aspects:

  • cGMP Design & Safety Review
  • Design Qualification including (Process, Facility Design, Construction & Finishes)
  • Preparation for Quality Assurance & Regulatory Inspection
  • Annual Requalification (Sterilising & Temp Controlled Environments)
  • Deviation / CAPA Management
  • Environmental Systems – HVAC & Containment
  • Cleanroom Qualification (ISO14644)
  • Building Services & Clean Utilities – Pure Steam, 
  • PW, WFI & Gases
  • Steam Quality Testing (EN285)
  • Liquid Products, Parenterals & Solid Dosage Forms (e.g. Powder / Tablets)
  • Aseptic Filling & Isolator Technology
  • Sterilisation Processes (EN285, ISO17665, ISO13408)
  • Depyrogenation Processes
  • Packaging – Design & Operation
  • Manufacturing Operations & Improvement
  • Process Control, Automation & Data Management

Pharmaceutical Manufacturers and Healthcare Service Providers

Adamson Pharma can assist Pharmaceutical manufacturers & Healthcare Service Providers increase effectiveness by ensuring Good Engineering Practices are being implemented.  

This in turn increases the degree of quality assurance evident in manufacturing systems. Our validation life cycle services will at all times be made specific to your corporate, system and equipment needs, but essentially will facilitate planning and execution pertaining to:

  • Risk-Based Approach
  • Validation Program Development
  • Validation Planning / VMP Generation
  • Validation Project Management
  • Full Life Cycle Documentation Packages, Witnessing & Reporting (URS / FAT etc)
  • Review of System Design Documentation (FDS, HDS, SDS, DS)
  • Qualification Protocol (DQ, IOV, IQ, OQ, IOQ & PQ) Development
  • Qualification Protocol Execution
  • Reports & Requirement Traceability Matrices
  • Cold Chain Validation
  • Validation Gap Analysis & Remediation
  • Cleaning Validation
  • Drawing Updates & all CAD Requirements
  • Thermal Mapping
  • Automation & Computer System Validation to GAMP 5 ®
  • Electronic Signatures & Records / Data Integrity

For an initial chat and a no-obligation quote, contact us on 01753 534826