LeanWays

“Always do right – this will gratify some and astonish the rest.” – Mark Twain

LeanWays

“Always do right – this will gratify some and astonish the rest.” – Mark Twain

Quality Risk Management for Cleaning Processes Improvements

Subject Matter Expert
TAKEDA / SHIRE – Belgium
via Altran

Context & Objectives:
In the manufacturing plant of the biotech company, install and implement a QRM approach for Cleaning
Validation.

Approach & Achievements:

  • Harmonization & Leaning of CV practices.
  • Support of site projects & personnel.
  • Recommendations on strategic options for CV & improvement proposals to Site
    Leadership Team.

Approach & Achievements:

  • Harmonization & Leaning of CV practices.
  • Support of site projects & personnel.
  • Recommendations on strategic options for CV & improvement proposals to Site
    Leadership Team.

Results & added value:

  • Worst case soiling / equipment grouping
    determination.
  • Determination of Stage 3 Validation
    Maintenance.
  • Teaching site personnel.
  • Financial assessments.

Results & added value:

  • Worst case soiling / equipment grouping
    determination.
  • Determination of Stage 3 Validation
    Maintenance.
  • Teaching site personnel.
  • Financial assessments.