Reusable quality at Sicor Biotech

Situation:

Sicor Biotech UAB is a biotech pharmaceutical company that develops and produces recombinant biopharmaceuticals using advanced science and production technologies.

The company needed to validate a large number of electronic spreadsheets used as calculation templates at its production facility in Vilnius, Lithuania.

Validation is a mandatory requirement of cGMP. Any computerized system that affects patient safety, product quality or data integrity must be appropriately validated.

Challenge:

To develop and implement a pragmatic strategy that would enable validation to be carried out as efficiently as possible in full compliance with regulations.

Solution:

Based on Sicor Biotech’s Quality Management System and “GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems,” PlantVision helped to develop a modular and reusable concept for the validation of the electronic spreadsheets. Validation was carried out in two phases.

① An initial electronic spreadsheet of medium complexity was validated. During the process, specific but reusable documents were developed, e.g. combined User Requirement Specification and Functional Specification (URFS), Risk Assessment, Qualification Protocol, Final Report, and a common Validation Plan.

② The lessons learned were used to optimize working methods. The remaining electronic spreadsheets were then validated in parallel, reusing the templates and principles established during phase one.

Results:

  • By establishing close cooperation, PlantVision gained a thorough understanding of Sicor Biotech’s internal processes, enabling the project to be planned very effectively.
  • Using a modular, risk-based and reusable validation concept enabled the company’s cGMP-critical electronic spreadsheets to be validated extremely quickly and cost effectively.
  • Carrying out risk assessment analyses for each electronic spreadsheet meant qualification tests could focus on the functions representing the most risk. This enabled validation to be carried out in a flexible, focused and scalable manner.