Analytical Method Development & Validation
About this service
We specialise in method development and validation, finished product quality control, raw materials testing, and stability evaluation. We follow a scientific and risk-based approach to develop and maintain analytical procedures used to test and characterize pharmaceutical products. Whether it involves verifying existing methods, modifying them, or developing new analytical techniques, we adhere to pharmacopeial requirements and internationally recognized ICH guidelines.
Analytical Method Development
Main focus on creating robust and reliable procedures for testing pharmaceutical products. This involves designing and optimising analytical methods that are tailored to the product’s unique characteristics. Our goal is to ensure that the methods are precise, accurate, selective, and capable of providing meaningful data for product evaluation.
Our approach to method development includes:
- Gaining a comprehensive understanding of the product’s properties and requirements.
- Identifying potential risks and taking proactive measures to mitigate them.
- Applying Quality by Design (QbD) principles to understand critical method parameters and their impact on results.
- Conducting thorough method suitability testing to confirm the methods’ applicability.
Analytical Method Validation
Method validation is a critical process to demonstrate that the developed analytical procedures are suitable for their intended use and consistently produce accurate results. We perform method validation following industry best practices and regulatory guidelines.
Our method validation process includes:
- Verifying accuracy and precision to ensure close agreement between measured and true values.
- Testing specificity and selectivity to accurately measure the analyte of interest in the presence of potential interferences.
- Establishing linearity and range to ensure reliable quantification across different analyte concentrations.
- If required, determining the Limit of Detection (LOD) and Limit of Quantitation (LOQ) to assess method sensitivity.
- Evaluating robustness and ruggedness to identify potential sources of variation.
- Establishing system suitability criteria to ensure proper functioning of the analytical instruments.
Phase Appropriate Method Development and Lifecycle Management
The analytical requirements of a pharmaceutical product may change throughout its lifecycle. Methods to be developed are tailored dependant on the stage of the product’s development. Methods are validated only as appropriate for the clinical phase that the product is to be used for. This ensures that the methods remain suitable, compliant, and cost-effective.
- Early-Stage Development (clinical phase I and II): Creating rapid and cost-effective methods to provide essential data for decision-making.
- Late-Stage Development (clinical phase III onwards): Refining methods to meet regulatory requirements and prepare for commercialization.
- Post-Approval Support: Managing the lifecycle of analytical methods and conducting periodic reviews and updates using the principles of Analytical Quality by Design.
Method Transfer and Verification
Efficient and accurate method transfer is crucial when moving analytical procedures
- Developing comprehensive transfer protocols outlining critical steps and acceptance criteria.
- Conducting comparative testing to confirm the equivalence of the transferred method.
- Troubleshooting and optimising the method as needed to ensure suitability and compliance.
Forced Degradation Studies and ASAPrime™ Impurity Profiling
Understanding the stability and degradation patterns of a product is essential for ensuring its safety and efficacy. We conduct Forced Degradation Studies, and use ASAPrime™ software to quickly and accurately determine product shelf-life.
We perform stress testing on pharmaceutical products under various conditions to simulate potential degradation pathways. Products are subjected to elevated temperature, humidity, light, oxidation, and other stress factors to identify and characterise potential degradation products. These studies are critical for assessing the product’s stability and establishing degradation pathways, which are essential for formulation development and ensuring the product’s shelf life.
Discriminating Dissolution Methods
Dissolution testing is critical in assessing drug release and bioavailability. Discriminating dissolution methods provide accurate data to support formulation development, process optimisation, and quality control.
Our discriminating dissolution methods encompass:
- Customising dissolution conditions to match a product’s unique characteristics.
- Implementing biorelevant dissolution methods when necessary to mimic in vivo conditions.
- Conducting comparative dissolution studies to evaluate different formulations or manufacturing processes.
Dissolution Biowaiver Studies
In certain cases, dissolution biowaiver studies can be conducted to support product development, saving time and resources associated with bioequivalence studies.
Dissolution biowaiver studies involve:
- Providing a scientifically sound rationale for conducting the studies.
- Preparing appropriate regulatory documentation for submissions.