LB Quality Process
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Qualification and Validation

Strategies, protocols, execution and documented evidence for facilities, equipment, utilities and processes.

Illustrative editorial image: Qualification and Validation
Our approach

Control demonstrated
through criteria and evidence.

Demonstrating control requires sound planning, justified technical criteria, traceable documentation and risk-proportionate assessment. The scope is defined by each system’s characteristics and criticality.

Technical scope

How we can help.

Systems and equipment

  • Validation master plans and qualification/validation strategies
  • Design, installation, operational and performance qualification, as applicable
  • Technical review and oversight of qualification studies for utilities, HVAC, equipment and classified areas performed by qualified teams or providers, where applicable
  • Facility qualification, within the agreed scope, and documentary review of studies performed by third parties

Processes and cleaning

  • Manufacturing process validation, including solid dosage forms and sterile products, as applicable
  • Development and oversight of cleaning validation
  • Aseptic process simulation, where applicable, and technical assessment of airflow visualization studies (smoke tests)
  • Holding-time studies, validation of material transfer processes into classified areas and continued process verification, where applicable

Services depend on the applicable regulatory framework and the agreed scope. Certificates and official approvals, where relevant, can only be issued by the competent authorities or accredited bodies.

Explore more

Related services.

QUALITY

Quality Management System (QMS)

PROCESSES

Engineering and Industrial Processes

REGULATORY AFFAIRS

Regulatory Intelligence and Affairs

Shall we review your situation?

Describing your technical need is the first step in identifying requirements, priorities and scope.

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