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Method Development, Validation and
Method Development, Validation and Transfer
Method validation is essential for compliance with current good manufacturing specifications (CGMP) and good
laboratory specifications (GLP). Analytical method validation (AMV) is the requirement of the biopharmaceutical
industry for all methods used in the testing of raw materials, in-process materials, final containers and excipients.
The development and validation of analytical methods are critical to drug development and access to reliable
analytical data that you need to reach your next development milestone. The development and validation of
methods can be complex, expensive, and labor-intensive. A full understanding of current regulatory expectations
and related chemical methods, coupled with advanced instrumentation, is essential for the development of
efficient, accurate and reliable analytical methods.
BOC Sciences is pleased to offer Analytical Method Development, Validation and Transfer services:
Methodologies will be developed to assess the ability to measure compounds of interest in the final solution
of interest in actual use. Specific analytical methods need to be developed and validated before any
quantitative leachate assessment of drugs can be carried out. Although deviations, such as lower validation
levels for some applications, are possible, MD&V (Method Development, Validation) is based on the ICHQ2
(R1) method validation guide. These tests may include parameter specificity, linearity, method range, accuracy,
precision, LOD/LOQ, and robustness.
All our work strictly complies with cGMP requirements, and our analytical operations are based on formal
written, detailed standard operating procedures and strict quality assurance measures.
* Services & Products Interested
Method Development, Validation