UNTIE®-Prozess.
In maximum 4 steps to your validated analytics.
Developed toether with experts.
These challenges
we would like to solve for you.
- new analysis required
- complex matrix
- Time pressure
- Cost pressure
Step 1: UNDERSTAND customer needs.
Requirement specification.
What we do:
- Development of a detailed requirement specification for the method.
- Definition of regulatory requirements.
- Discussion of practical limitations in terms of sample material and specification.
- Defining the scope and acceptance criteria.
How we work:
- CUP Contract Labs scientists in consultation with the client.
- Literature research.
Time required: approx. 1-2 weeks*
Step 2: TEST of existing method.
Feasibility.
What we do:
- Test of the agreed monograph or client method or the proposed method from step 1 for validation (method not yet modified).
- Preparation of a feasibility plan and report.
How we work:
- Scientists with laboratory experts from CUP Contract Labs.
- First laboratory test series.
Time required: approx. 1-2 weeks*
Step 3: INVESTIGATE
in method development.
Development report.
What we do:
- Development and optimization of an analytical method, e.g. by using different separation columns and/or detectors.
- Consideration of the requirement specification and the results of the feasibility test.
How we work:
- Scientists with laboratory experts from CUP Contract Labs.
- Comprehensive laboratory tests.
Time required: approx. 5 weeks*
Step 4: EXECUTION of validation
according to ICH Q2 (R2).
Validation report.
What we do:
- Product-specific validation of the analytical method according to ICH Q2.
- Preparation of the validation plan.
- Preparation of a validation report.
How we work:
- Scientists with laboratory experts from CUP Contract Labs.
- After agreed requirement specification from step 1.
- After successful feasibility test from step 2 and/or successful method development (step 3).
- Carrying out all necessary series of measurements.
Time required: approx. 4 weeks*
*All times refer to internal working hours and may vary depending on delivery times and customer availability.
Developed together
with one of the best experts.
Together with our long-standing partner and HPLC expert Stavros Kromidas, we were able to jointly develop the UNTIE® -process and publish it in his book. We are proud of this.
In maximum 4 steps
to your validated analytics.
