About Lean GMP
The refinement and optimization of implementing GMP quality standards requires daily teamwork in different operation units and disciplines.
Designing validation and qualification concepts, quality control, quality assurance, manufacturing and IT, work at its best closely together in qualification or validation teams.
When we develop those validation and qualification strategies, we apply the Lean GMP Validation Concept. This helps us to follow refinement and reduction but keep to the regulatory expectations.
For our clients, it saves time and money by avoiding unnecessary, time-consuming, and costly validation and qualification activities. In regular project meetings, we develop and optimize the approach on implementation of qualification and validation concepts.
Our validation engineers are equipped with mind and reason to establish the objectives of your validation and qualification strategy.
Objective
Lean GMP validation aims to emphasize on an effective and efficient validation or qualification strategy to avoid time-consuming and costly Q&V activities.
Risk Assessment
Emphasize your qualification and validation strategy risk-based and focused on critical quality attributes (CQAs) and critical process parameters (CPPs).
Lean Validation Strategy
- Form interdisciplinary validation team
- Define precisely the validation activities
- Devise precisely the User Requirements Specification (URS)
- Incorporating of SAT and FAT
- Precisely specify documentation
Summary
When establishing the validation strategy remain focused and use common sense to establish the validation and qualification objectives.
Keep to the Lean Validation Strategies. This helps you to avoid costly and time-consuming retesting.
Precisely define your validation activities. Devise an intelligent URS and risk analysis. Avoid retesting where possible. Make the documentation as lean as possible.