LB Quality Process
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Quality Management System (QMS)

Assessment, development and improvement of quality systems, with an emphasis on risk, evidence and control.

Illustrative editorial image: Quality Management System (QMS)
Our approach

Quality as a system.
Evidence in operations.

Quality needs to be embedded in operations and decision-making. Our work considers the maturity of each system, the applicable health requirements and the evidence needed to maintain a state of control.

Technical scope

How we can help.

Systems and governance

  • Assessment, adaptation and implementation of Quality Management Systems
  • Audits and gap assessment
  • Qualification and assessment of manufacturers, suppliers and service providers
  • Change control, deviations, CAPA and quality indicators
  • Quality risk management and assessment of action effectiveness

Documentation and control

  • Development and review of procedures, manuals, plans and technical records
  • Documentation of systems, facilities and processes
  • Product Quality Review, where applicable
  • Contamination Control Strategies (CCS) in line with applicable guidance

Qualification and validation

  • Planning and oversight of cleaning validation
  • Development of strategies and protocols for process validation
  • Aseptic Process Simulation (APS / media fill), where applicable
  • Holding-time studies and continued process verification
  • Facility qualification and technical assessment or oversight of equipment, utilities and support-system qualification studies, within the agreed scope

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.

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Related services.

PROCESSES

Engineering and Industrial Processes

REGULATORY AFFAIRS

Regulatory Intelligence and Affairs

QUALITY + PROCESSES

Qualification and Validation

Shall we review your situation?

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

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