Analytical Method Validation Services
Gain an experienced partner with a good working knowledge of method validation requirements suitable for different phases of development. Valentia Analytical respects the highest standards of the pharmaceutical industry by following relevant ICH guidelines such as ICH Q2 (R1) or Pharmacopoeial methods/compendia guidance in combination with client-specific protocols.
cGMP laboratory method validation
Analytical method development and method validation are part of an integrated quality program. It refines the deliverable of the method by validating it for use in the intended operating environment. Process conditions throughout the lifecycle are in addition to the accuracy of the analysis, and rely on qualified and selected controls in the media as well as the integrity of the equipment and personnel involved in the implementation of the method.
Choose Quality by Design
Our team is located in California, where our new laboratory facility utilizes a wide range of analytical technology to meet your specific drug's analytical needs. Save on time, reduce your costs and concentrate on your core activities thanks to a reliable method development and validation partner. Bringing quality and safety to life, Valentia meets and exceeds your quality, safety and regulatory standards.
Analytical method validation services
Valentia’s method validation confirms the method is reliable based on factors such as specificity, precision, accuracy, and robustness. Our work and ability ensure the accuracy of the results and proves that the method is right, fit-for-purpose, and quantified accurately for your targeted compound.
Bio-analytical assays
Identification
Assay testing
Testing for impurities
Stability indicating methods
Light stressing
Microbial testing
Particle size analysis
Why work with a cGMP laboratory?
Valentia has been leveraging years of experience across industries to develop robust analytical methods for techniques including UHPLC, HPLC, CE-SDS, CIEF, and GC. We conduct validation according to regulatory guidelines including ICH Q2. Our analytical professionals use cutting-edge equipment and techniques to generate methods trusted by industries around the world.
Choose Valentia Analytical for your analytical method development
As a leader in analytical services, Valentia Analytical has a wide range of core capabilities, a high level of skilled staff that understands how to address your individual needs and an approach based on delivering the data you need to make informed decisions. We are proud to provide pharmaceutical companies with a reliable validation protocol relying on innovative analytical procedures, extensive experience and knowledge of regulatory requirements.
Our mission: Return data fast with utmost quality
Valentia’s analytical laboratory is supported by strong foundations of expertise, quality and reliability. We strive to not only be compliant to all requirements and regulations, but to be a model of efficient analytical testing in America. Quality by Design is deeply embedded in our own laboratory and quality systems so we can better support you.
Committed to upholding cGMP standards, our mission is about returning data fast with utmost quality. The faster we deliver… the faster your new drugs and products can help patients around the world.
Learn more about method validation and Valentia Analytical’s services
Analytical validity, also known as method validation, is the process used to determine the suitability of an analytical method. The purpose of method validation is to provide evidence that the analytical method is fit for its intended purpose. It characterizes method performance based on quantitative aspects, although qualitative aspects such as analyte identity can also influence method suitability.
Biological tests and pharmaceutical product tests require method validation. Validation is a requirement for entities involved in developing and introducing drugs and testing samples for drugs, and is also of great value for any type of routine testing that requires consistency and accuracy. They can be performed at any stage of the drug product development, preclinical and clinical.
What are the requirements of method validation?
The requirements of analytical method validation will vary according to its purpose. There are guidance documents employing considerations of specificity, accuracy, linearity, precision, robustness, limits of detection, limits of quantitation, and effectiveness as a stability indicator. Quality design evaluating these elements are directly corrected to the intended purpose of a method. For example, the design of the validation varies depending whether it is used for identification, quantation, impurities, or as a limit test.
Analytical method development can be described as the process of designing, developing and validating a test designed to measure a specific drug’s characteristics in samples. A well designed and validated analytical method is the important step in the development process according to Good Laboratory Practice (GLP).
The aim of analytical method development is to design tests that will measure the drug substance or API (Active Pharmaceutical Ingredient). Tests for identity, purity, permeability, stability and potency of drugs, bioavailability and stability are a part of this overall aim.
The validation of methods ensures that a specific method is suitable for its intended purpose. It must be fully demonstrated in the laboratories and shown to be valid for the job it is designed to do. So in laboratory quality control, we prove that the specific analytical procedure is suitable for its intended purpose.
This implies that whenever a method is altered or the test sample changes outside of the originally validated scope, the validated method must be verified. Different parameters can be re-evaluated so that they fit an acceptable change, such as when a method is used in a new environment. Whether the method is used for release or stability testing, it must be proven as fit for its intended purpose so that an effective regulatory and control strategy can be used.
What is the difference between method validation, partial validation and method verification?
Method validation is the process that establishes performance characteristics, based on factors such as precision, specificity and robustness, while partial validation is performed on a method that was previously validated, but has undergone some modifications. On the other hand, method verification aims to confirm that the validated method works as intended under the conditions of its actual use.
Both are important, as the performances of a validated method may change with different applications or different methods. Method verification doesn't require a full reassessment of all the performance characteristics.
There are three method validation protocols used during a drug development program: Full, Partial, and Cross-Validation.
Full validation is needed for the new methods if they haven't been used before, or when major changes to the existing method affect the scope or critical components;
Partial validation is a way of confirming that the assay is accurate even with changes in quantitation range or equipment.
Cross-validation is when two or more bioanalytical methods are used to generate data within the same study or across different studies to assess elements such as inter-method equivalency.
Method validation is a critical activity which is required by good manufacturing practices (GMPs) and cGMP’s like Valentia Analytical. Guidelines exist for this from major organizations such as the FDA, the European Commission, and the Food Safety Management Committee.
The validation of methods is done according to eight criteria: accuracy, precision, specificity, linearity, detection limit, quantitation limit and robustness.
Accuracy
The accuracy of an analytical method measures how close results from that method are to the true value.
Precision
The precision with which a particular analytical method gives reproducible test results is called its precision. It is measured according to three factors:
- Repeatability: Can the procedure be done repeatedly by an analyst using the same equipment;
- Reproducibility: Can the procedure be done in a different laboratory;
- Intermediate precision: The intermediate precision measures lab variations on different days, different analysts, different equipment and other events;
Specificity
Specificity is the ability to target the right analyte when elements such as impurities, degradation products or other components of the sample matrix are present in pharmaceutical products. The used method should see the difference between compounds of closely related structures and the analyte, and be unaffected by said materials.
Linearity
Linearity is the ability for a method that provides a precise and proportional relationship to the analyte concentration. Good statistical methods provide information that is in direct proportion, which maps the analyte concentration range on the graph or chart allowing for accurate decisions.
Limit of detection and Limit of quantitation
Limit of detection: The detection limit is the lowest concentration at which an analyte can be detected in samples, not quantified;
Quantitation limit: The limit of quantification is the lowest concentration at which a test can be identified with acceptable precision and accuracy;
Robustness
The robustness of an analytical procedure during normal usage is measured by how well it performs when environmental variables or parameters are slightly shifted. It provides an indication as to how well the analytical procedure performs and how appropriate it is during normal usage.