PDA Technical Report No. 57

PDA Technical Report No. 57 : Analytical Method Validation and Transfer for Biotechnology Products

Similar to the manufacturing process, an analytical method can also be considered a process. The validation strategy for analytical methods could therefore conceptually follow those of Process Validation. As such, Analytical Method Validation (AMV) can be defined as the collection and evaluation of data from the analytical method development stage throughout routine QC testing which establishes scientific evidence that an analytical method is capable of consistently delivering accurate and reliable results.


i am new to analytical method validation in bulk.

can u brief me the analytical method validation,if possible.

Thanks in advance