CQV

20 years of CQV success

Adamson pharma has significant experience implementing both traditional V model and risk-based approaches to Commissioning and qualification (C&Q) activities. Our Risk-based approach assures that elements with the greatest risk to product quality are subjected to the highest level of rigour during C&Q execution. Our criteria for assessment can be tailored to meet your corporate quality mandates but is fundamentally based on that described within ISPE Baseline Guide Volume 5: Commissioning and Qualification, 2nd Edition which encompasses ASTM E2500 and ICHQ9.

Expertise

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

Pharmaceutical Manufacturers and Healthcare Service Providers

Adamson Pharma can assist Pharmaceutical manufacturers and Healthcare Service Providers increase effectiveness by ensuring good engineering practices are being followed and documented. 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 can 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 and PQ) Development
  • Qualification Protocol Execution
  • Reports and Requirement Traceability Matrices
  • Cold Chain Validation
  • Validation Gap Analysis and Remediation
  • Cleaning Validation
  • Drawing Updates and all CAD requirements
  • Thermal Mapping
  • Automation and Computer System Validation to GAMP 5 ®
  • Electronic Signatures and Records / Data Integrity

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