Method Validation

Method validation is a process usually used to test whether the employed analytical procedure is suitable for its intended use and can meet the requirements of cGMP, GLP regulations and other organizations. Analytical method validation has been recommended as an essential tool in ensuring product’s quality for a variety of manufacturing. Especially for the pharmaceutical development, such strategy has gained a lot of importance to choosing and optimizing methods that applied for testing raw materials, in-process materials, final containers and excipients. BOC Sciences has a team of highly skilled analysts to support its clients with their need for method development & validation as per their specifications for reduction of time and cost along with catering to their need for accurate & precise results.

Figure 1. Types of analytical method validation

BOC Sciences generally provides three types of validation:

• Full Validation: Suitable for those newly developed approaches or additional analyses/ metabolites
• Partial Validation: C to modify the already validated bio/analytical method
• Cross Validation: Generally applied for comparing validation parameters when more than one methods are used

Our team of experts can offer method validation services including but not limited to:

• Newly developed material or with new compounds
• Validation of samples that from different analyst
• New instruments
• Different environmental conditions, chemicals, analytical parameters
• Method is validated once its performance is verified
• Establishment of the intended use of the method and its performance requirements
• Development of a validation protocol
• QC and QA compliant execution of assays
• QC all data
• Optimize and finalize the test method

Given the significant role of biopharmaceuticals in treating some specific diseases such as cancer, we also provide method validation services for the biological products:

• Selectivity
• Matrix effects
• Accuracy
• Precision
• Reproducibility
• Sensitivity
• Linearity and range
• Lower limit of quantitation (LLOQ)/Upper limit of quantitation (ULOQ)
• Stability evaluations
• Effect of haemolysed/lipaemic samples and dilution evaluation

To ensure that your method validation needs are met more accurately and quickly, we have employed the highly efficient work flow as follows:

• Analyzing the new compounds
• Planning the method validation policy as per requirement
• Validating samples from different analyst
• QA reviewing and data submission to QC Department
• Validating method once its performance is verified
• Compiling data

We have a statistical team that is capable of establishing equivalency across samples and instruments through the use of statistics. A statistical analysis package can be provided by our experts to give you additional value which can further examine the test data, establish equivalency between test variants, and evaluate the impact of specific factors to optimize results. Additionally, a comprehensive report will be finally provided for each statistical evaluation conducted, including the design used, the results, and statistical conclusions.