Analytical methods – development, validation, transfer

Analyses are carried out by either standardized methods, officially recommended (e.g. pharmacopoeial) ones, or customers’ methods, or methods developed by PozLab. We are also prepared to optimize methods used already by the customer, if for any reason their application is not satisfactory. Methods are developed according to scientific basis, with particular attention paid to meet legal requirements and customer’s needs.

The in-house developed methods or standardized methods, the scope of which does not coincide with the range specified in the method description, are validated according to proper requirements. In the case of drug products and materials for pharmaceutical industry, methods are validated in accordance with the ICH Q2(R1) Validation of Analytical Procedures guidance. In the case of methods applied for impurities determination, the development and validation of analytical methods follow the recommendations contained in relevant ICH guidelines:

Q3A(R2) – Impurities in New Drug Substances

Q3B(R2) – Impurities in New Drug Products

Q3C(R5) – Impurities: Guideline for Residual Solvents.

Method developed in PozLab might be further used in our laboratory to carry out analyses requested by customer and/or can be transferred to customer’s laboratory.