On-site Analytical Method Development and Validation
The method is developed and validated in your laboratory, on the instruments it will run on every day
- No method transfer
- Method protocol and validation report
- Cosmetics, pharmaceuticals and raw materials
Why does Percevia validate methods on-site?
With Percevia Lab Acceleration, Percevia develops, optimizes, implements and validates analytical methods for the characterization of molecules, focused on manufacturing quality control. The work is done exclusively on-site: a Percevia scientist is assigned to your operation and works with your laboratory's infrastructure and instruments.
When a method is developed and validated in the environment where it will be applied, the validation reflects the real routine conditions: the same instruments, the same infrastructure and the same constraints on analysis time and cost.
This removes the transfer of the method between laboratories, a step in which differences in sensitivity and resolution between instruments may require adjustments.
Validate on-site, or validate off-site and transfer the method?
Another common way to obtain a validated method is to develop and validate it in an external laboratory (off-site) and then transfer it to the laboratory where it will be used. Here is how the two routes compare.
| Criterion | On-site (Percevia) | Off-site with transfer |
|---|---|---|
| Where the method is developed and validated | In the client's laboratory | In an external laboratory |
| Instruments used for validation | The routine instruments | The external laboratory's, which may differ from the routine ones |
| Method transfer | Not needed | Needed after validation |
| Instrument differences | Do not apply, since the method is validated on the destination instrument | Differences in sensitivity and resolution may require adjustments during transfer (FTIR is one example) |
| Client team | Follows development in its own laboratory | Receives the finished method at transfer |
| Use of the client's laboratory during the project | Requires laboratory access and instrument availability | Does not occupy the client's laboratory until transfer |
On-site validation
Advantages
- The method is validated on the instruments it will run on in the routine.
- No transfer between laboratories and no adjustments for instrument differences.
- Development accounts from the start for reproducibility, analysis time and cost in the real routine.
- The client's team follows the work in its own laboratory.
What it requires
- Laboratory access and instrument availability during the project phases.
- Techniques chosen among those compatible with the available infrastructure.
Off-site validation with transfer
Advantages
- Does not occupy the client's laboratory and instruments during development and validation.
- Development can use the external laboratory's infrastructure.
Limitations
- Requires an additional method transfer step after validation.
- The method is validated on instruments that may differ from the routine ones.
- Differences in sensitivity and resolution between instruments may require adjustments to the method during transfer. FTIR is one example of a technique in which these differences can be relevant.
- The client's team receives a finished method without having followed its development.
What is the starting point of analytical development?
The first decision in a project is whether an analytical specification with established parameters and ranges already exists.
From there, the strategy can follow one of two paths.
When there is no analytical specification yet
The project may involve:
- complete structural and physicochemical characterization of the molecule;
- identification of Critical Quality Attributes (CQAs);
- definition of acceptance criteria;
- selection of analytical techniques compatible with the client's infrastructure;
- method development focused on robustness, selectivity and applicability in quality control.
When an analytical specification already exists
The work may involve:
- critical assessment of the established parameters and criteria;
- development, optimization and/or adaptation of analytical methods;
- verification that the method is fit for purpose;
- adjustments for the quality control routine, considering reproducibility, analysis time and cost.
How does an on-site project work?
The project is organized into five sequential phases, carried out in the client's laboratory.
- 1
Diagnosis and Strategy
Definition of the analytical approach, scope and applicable techniques.
Estimated time: 1 to 2 weeks.
- 2
Analytical Development
Initial development of the methods.
Estimated time: 2 to 4 weeks.
- 3
Analytical Validation
Evaluation of the validation parameters. The parameters evaluated include precision, accuracy and linearity, along with others that apply to the project.
Estimated time: 2 to 4 weeks.
- 4
Documentation and Reports
Issue of the technical reports and documentation for the validation and the methods developed.
Estimated time: 2 to 4 weeks.
- 5
Post-Implementation Support
Technical support for adjustments and operational questions after delivery.
Planned period: 2 months of support.
How long does an on-site project take?
An on-site project takes approximately 7 to 14 weeks to complete the diagnosis, development, validation and documentation phases.
This is followed by 2 months of post-implementation support.
These times are estimates and may vary with the characteristics and scope of each project.
What do we deliver?
Over the course of the project, we deliver:
Protocol for the developed method
Documentation of the analytical method established during the project.
Analytical validation report
Technical record of the results of the validation process.
Guidelines for application and routine use
Guidance for applying the method in the operational routine.
Post-implementation support
Two months of technical support for adjustments and operational questions after delivery.
Companies that trust Percevia
Some of the companies and institutions Percevia has worked with:
- Beiersdorf
- Croda
- Brenntag
- Blanver
- SENAI
- Polícia Científica
- Concepta Beauty
Methods developed for the quality control routine
A method intended for quality control must account not only for its analytical performance but also for the conditions in which it will be used.
For that reason, development can consider factors such as robustness, selectivity, fitness for purpose, reproducibility, analysis time, cost, available infrastructure and the product's maturity stage.
The goal is to develop methods aimed at quality release and aligned with the client's technical, regulatory and operational requirements.
Which techniques do we develop and validate methods on?
The techniques on which Percevia develops and validates analytical methods include HPLC, GC, UV-Vis and FTIR.
The technique is chosen according to the molecule, the parameter to be controlled and the instruments available in your laboratory.
Which sectors is Percevia Lab Acceleration for?
Percevia Lab Acceleration serves:
- Cosmetics
- Pharmaceutical industry
- Raw materials
One of Percevia's three divisions
Lab Acceleration is Percevia's division 02, serving Quality teams (development and validation). The other two are Characterization, a partner to R&D teams in developing new products and formulations, and Biosensors, focused on continuous monitoring and lower cost in routine analysis.
On-site analytical method development and validation with Percevia
Whether your company needs to develop a new method, work from an existing specification, optimize or adapt a method, or prepare it for use in quality control, Percevia structures the project around the product's stage and the available infrastructure.
All the work happens in your laboratory, with your instruments.
Frequently asked questions
What is Percevia Lab Acceleration?
Percevia Lab Acceleration is the Quality division of Percevia, a Brazilian analytical laboratory based in São Paulo. It develops, optimizes, implements and validates analytical methods on-site, in the client's laboratory and on the instruments the method will run on, for quality control of cosmetics, pharmaceuticals and raw materials.
Why validate an analytical method on-site?
Because the method is developed and validated on the same instruments and under the same conditions in which it will be used routinely. There is therefore no transfer between laboratories, a step in which differences in sensitivity and resolution between instruments may require adjustments to the method.
What is the difference between validating on-site and validating off-site and transferring the method?
In on-site validation, the method is developed and validated in the client's laboratory, on the routine instruments. In off-site validation, the method is validated in an external laboratory and then transferred to the client's laboratory. Transfer is an additional step and may require adjustments when the instruments differ in sensitivity or resolution. Percevia works on-site only.
What is analytical method transfer?
Analytical method transfer is the process of moving a method developed and validated in one laboratory to another laboratory where it will be used, verifying that it remains suitable on the new instruments. In Percevia's on-site model this step is not needed, because the method is already validated in the destination laboratory.
What is analytical method development?
Analytical method development is the process of choosing the technique and setting the conditions of a method so that it measures what it needs to measure, with the selectivity and robustness suited to its intended purpose. At Percevia, development is aimed at the characterization of molecules and the use of the methods in quality control.
What is the difference between analytical method development and validation?
Development establishes and adjusts the analytical method. Validation evaluates its performance to confirm that it meets its intended purpose. Validation includes parameters such as precision, accuracy and linearity, among others that apply to the project.
Which techniques does Percevia develop methods on?
The techniques include HPLC (liquid chromatography), GC (gas chromatography), UV-Vis and FTIR. The technique is chosen according to the molecule, the parameter to be controlled and the instruments available in the client's laboratory.
How long do development and validation take?
The four phases before support take approximately 7 to 14 weeks. This is followed by 2 months of post-implementation support. These times are estimates and may vary by project.
Does a method developed on one instrument automatically work on another?
Not necessarily. Differences in sensitivity, resolution and instrument characteristics may require adjustments when a method is transferred. FTIR is one example of a technique in which these differences can be relevant. This is why Percevia develops and validates methods on-site, on the instruments they will run on.
What does fit-for-purpose mean?
Fit-for-purpose means verifying that a method is suitable for the purpose for which it will be used. At Percevia, this verification is part of projects in which an analytical specification already exists.
Does Percevia work with existing methods?
Yes. When an analytical specification already exists, the project may involve critical assessment, development, optimization or adaptation of the method, and verification that it is fit for purpose.
Which sectors is the service aimed at?
Percevia Lab Acceleration serves cosmetics, the pharmaceutical industry and raw materials.