GLP and cGMP Analytical Chemistry Services
Employing state-of-the-art instrumentation in HPLC, GC, and mass spectrometry, VxP Pharma develops analytical chemistry methods from initial concept to validation and can verify or improve existing methods for the analysis of a wide range of active compounds. All analytical services can be provided to meet GLP/GMP guidelines (or non-GLP as requested) for both small molecule and large molecule programs.
Method validation is an important part of the overall qualification process that establishes, through rigorous testing, that the performance characteristics of the method meet the requirements of the intended analytical application. Method validation provides an assurance of reliability of laboratory studies during normal use, and is sometimes referred to as the process of providing documented evidence that the method does what it is intended to do. In addition to being good science, regulated laboratories must carry out method validation in order to be in compliance with governmental and/or other regulatory agencies. A well defined and documented method-validation process not only satisfies regulatory compliance requirements, but also provides evidence that the system and method are suitable for their intended use.
An effective analytical method development process involves evaluating and optimizing various method parameters to satisfy the goals of the procedure; a properly developed and optimized method can help to insure its success upon implementation. Many different approaches to method development have evolved, however the basic premise of changing selectivity to effect a separation that satisfies requirements of the method is the common theme. A comprehensive method development approach also often involves forced degradation studies, robustness development, standard addition, and other pre-validation studies performed to insure the resulting method can be validated.
At VxP Pharma, we have extensive experience with Method Development, and Method Validation, as well as meeting FDA, GMP, and ISO requirements.
The state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.
Method Development and Validation Services
- Assay method development and validation services as per ICH/FDA/USP guidelines:
- Impurities method development and validation services as per ICH/FDA/USP guidelines:
- API / Other drug substances
- Preformulation / Drug – Drug / Drug – Excipient compatibility studies
- Finished drug products
- Devices containing pharmaceutically active compounds
- Stability testing programs
- Dissolution method development and validation per ICH/FDA/USP guidelines:
- Intrinsic dissolution / Solubility of API or other drug substances
- Finished drug products including modified release dosage forms
- Stability testing programs
- Cleaning validation method to determine if any residual agents or active compounds are present in equipment/facilities
- Coupon/swab recovery
- Material recovery from swab after controlled spike