Qualification & Validation Services

We offer a wide range of Qualification and Validation services, and have experience in the following areas;

• Annex 1 – Manufacture of Sterile Medicinal Products
• Medical Devices: ISO 13485
• Advanced Therapy Medicinal Products (ATMPs)
• Active Pharmaceutical Ingredients (APIs)
• Biotechnology
• Chemical Plants

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Commissioning and Qualification documentation packages

Our team of experts can provide you with a full documentation package tailored to your requirements.

We can work with the qualification templates and protocols provided as dictated by your Quality Management System, or we can draft the required documentation and protocols designed specifically for your project including;

Validation and Commissioning Planning/Reporting

BSL use a risk-based approach to validation planning, incorporating the use of a leveraging strategy where possible. We work with suppliers to ensure that commissioning, qualification, and validation documentation from suppliers is of the required standard to be leveraged into the qualification documentation. Using this approach, with the focus on quality critical elements, the overall on-site testing requirements can be reduced, introducing significant time and cost savings.

Commissioning is a key component of the CQV lifecycle, it is a systematic approach to the start-up and turnover of facilities, systems, and equipment to the end user to ensure that user requirements are met. Commissioning planning and development of the commissioning strategy is a vital part of CQV and must be defined alongside validation planning or be incorporated into the Validation Master plan.

URS

We work with the client to ensure that the URS is produced in line with the current compliance and regulatory guidance and that the requirements are SMART and unambiguous;

  • Specific
  • Measurable
  • Achievable
  • Realistic
  • Time-bound

The URS can also be used to define the CQV expectations of the client to the supplier and feed into the validation planning and leveraging strategy.

Factory and Site Acceptance Testing (FAT & SAT)

At BSL we advocate leveraging of factory and site commissioning testing as part of the overall CQV strategy.  We ensure that particular attention is paid to the standard of documentation generation and completion at these stages so that it can meet the quality system requirements and be leveraged into the validation package, reducing the need for re-testing.

System and Component Impact Assessments
Computer System Risk Assessments
Requirements Traceability Matrix
Commissioning Testing/Start-Up and Turnover (IV/OV)
  • Installation Verification
  • Operational Verification/Functional Testing
Design Qualification and Design Reviews (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Decommissioning Testing

There are many factors to consider during the decommissioning process, including documentation, process management, Environmental, Health, and Safety (EHS), compliance, financial, operational, maintenance, supporting contracts, and interfaces with other facilities and site utilities.

The retiring of equipment, systems and facilities needs to be managed to ensure business continuity and GxP compliance up to, during, and post disposal/retirement. BSL ensure that this is managed and executed in a planned, controlled, and cost-effective way that ensures patient safety throughout.

Revalidation and Periodic Reviews

BSL advocate a risk-based approach to revalidation and defining the revalidation strategy, this approach also allows the scientific justification of the periodic review frequency.  Routine revalidation should be applied to high-risk processes such as sterilisation and aseptic processing.

Risk Assessments

We offer extensive experience in Quality Risk Management, based on the principles in ICH Q9 to ensure that the evaluation of the risk to quality is based on;

  • Scientific knowledge with the focus on the protection of the patient
  • The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.

BSL work with interdisciplinary teams to identify the perceived failure with respect to process, equipment, facilities and systems using the following non exhaustive list of tools;

  • Failure Mode Effects Analysis (FMEA);
  • Failure Mode, Effects and Criticality Analysis (FMECA);
  • Fault Tree Analysis (FTA);
  • Hazard Analysis and Critical Control Points (HACCP);
  • Hazard Operability Analysis (HAZOP)

Equipment Qualification

Qualification refers to the activities undertaken to demonstrate that systems, utilities and equipment are suitable for their intended use and perform as stated in the User Requirement Specification. Qualification activities focus on the those elements, instruments or components of the system that are considered to be critical to product quality. Those elements that have an indirect or no impact to product quality may be commissioned only.

BSL has experience in the commissioning and qualification of wide range of equipment and systems, ranging from small laboratory and bench top equipment to entire facilities including;

  • Utilities
    • Water systems – Purified, WFI, Chilled and Softened water
    • Clean and Plant steam
    • Instrument and Process air
    • Process Gases – Nitrogen, CO2
    • Electrical and UPS systems
  • Clean Room Validation (in line with ISO 14644)
    • HVAC commissioning and balancing
    • Smoke Visualisation
  • Manufacturing Equipment
    • Fermenters
    • Isolators
    • Tablet Press Machines
    • Fillling Lines
    • Packaging Lines
    • Tanks and Vessels
  • Laboratory and Small Bench Top Equipment
    • Biological Safety Cabinets
    • Laminar Air Flow Cabinets
    • Balances, Centrifuges, pH/Conductivity Meters
    • Bench Top Autolcaves
    • Cell Counters

Computer System Validation

At BSL we have a wide range of experience in Computer Systems Validation, from standalone software systems to immersed system equipment including;

  • Laboratory Information Management System (LIMS)
  • Enterprise Management Systems (EMS)
  • Building Management Systems (BMS)
  • HPLC & UPLC
  • Real Time PCR
  • Electronic Chart Recorders (e.g. Eurotherm, Yokogawa)
  • PLCs, Controllers and Control Panels for Equipment
  • Bar Coding and Vision systems
  • Control Systems
  • Spreadsheet Validation

Cleaning Validation

BSL have experience in implementing cleaning validation programmes in both multi product and dedicated product facilities and associated Analytical Method Validation for detection.

Process Validation and Aseptic Process Simulations

We have carried out process validation for active substances, biological medicinal products and medical devices.

Temperature Mapping

BSL has over 20 years’ experience in temperature mapping including the following using a range of temperature mapping devices;

  • Warehouses
  • Fridges, Freezers and Hot/Cold Rooms
  • Incubators
  • Autoclaves
  • SIP Systems
  • Sterilsing Ovens and Tunnels

We are able to provide the use of our  SenseAnywhere™ data loggers, calibrated to UKAS standards, for your temperature mapping projects. These AiroSensor loggers provide accurate monitoring over a range of -40⁰C to +70⁰C.