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.