New Microbiology Laboratory

10/09/2020

In the pharmaceutical industry, ensuring compliance with regulatory requirements is of the utmost importance. Laboratory Equipment Validation (LEV) is a key aspect of this compliance, as it verifies that equipment and systems in the laboratory are capable of consistently performing according to their intended use. KVALITO, a leading provider of validation and compliance services, was engaged to support a pharmaceutical company in their LEV efforts for a new build Microbiology Laboratory.

 

Challenge

The company faced several challenges in their LEV process for the new laboratory. Challenges included resources, timelines and Covid;which had an impact on timelines and presented challenges to executing validation.

 

What KVALITO did

KVALITO worked closely with the company to address these challenges and improve its LEV process. Our Validation Engineers facilitated the Laboratory Equipment Validation for the new build Microbiology Laboratory. This included:

  • Documenting and successfully testing all LEV requirements.
  • Maintaining up-to-date knowledge of EMA and FDA regulatory requirements.
  • Participating in project meetings and supporting the project team in all project-related topics.
  • Coordinating and communicating validation issues to team members and management.
  • Ensuring equipment changes were implemented according to change control procedures.
  • Updating equipment procedures, Trackwise and Vendor agreements.
  • Coordinating Vendor site visits, witnessing and documenting validation activities.
  • Completing work as necessary within the scope of the contract.

 

Roles & Responsibilities

KVALITO provided a dedicated team of validation experts to work on the project. Our Validation Engineers were responsible for the following:

  • Ensuring all performance qualification (PQ) requirements are documented and successfully tested. (Including deviation management).
  • Maintaining up-to-date knowledge of EMA and FDA regulatory requirements.
  • Participation in the various project meetings and supporting the project team in all project-related topics
  • Project coordination and communication of validation issues to team members and management.
  • Ensure equipment changes are implemented as per change control procedures.
  • Completing work as necessary within the scope of the contract.
  • Deliverables for Project:
  • Performance Qualification (PQ) protocols and test scripts
  • Action plan for Performance Qualification (Planning dates and resources)
  • PQ report

 

Processes and Tools

KVALITO used a variety of processes and tools to support the project, including:

  • Regulatory research and analysis to ensure compliance with EMA and FDA requirements.
  • Change control procedures to ensure equipment changes were implemented correctly.
  • Project management tools meetings to coordinate and communicate with the project team.
  • Document management systems to maintain accurate and up-to-date records.

 

Value Delivered

Through KVALITO’s efforts, the company was able to successfully document and test all LEV requirements for the new build Microbiology Laboratory, maintain compliance with EMA and FDA regulations, and improve coordination and communication within the project team. This ensured that the company was able to meet regulatory requirements and improved its overall efficiency and effectiveness in the LEV process, ultimately saving time and money. The deliverable LEV protocols, test scripts, action plan and LEV report, helped the company prepare for future audits and ensure the new Microbiology Laboratory fully complies with the regulations.

 

Client Reference

  • Allergan / AbbVie

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