Verification, Validation and Transfer
Methodverification, Mehthodvalidation and Methodtransfer
Analytical service providers have made it their business to support companies in the pharmaceutical sector with the necessary documentation and assurance of product quality.
The basis for this are analytical methods that deliver reliable, correct and reproducible results. In order to meet the strict regulatory requirements, these must therefore be verified or validated.
A verification is a suitability test or partial validation of an already existing, valid pharmacopoeia method, in which only the suitability of the method under the environmental conditions of the performing laboratory is tested.
For simple pharmacopoeia methods, such as pH measurements, verification is usually not necessary. However, the more complex the analytical procedure or sample preparation, the more likely verification is required and the greater the scope of verification.
Decisions for or against verification are always made in close consultation with the respective customer.
If the method is to change from one lab to another lab, this is referred to as a method transfer. It represents a proof that qualifies the target laboratory to successfully perform a transferred method.
Validation is intended to ensure that a method is suitable for its intended use and provides reliable and reproducible results at all times, irrespective of the person performing the test.
Validation is required when a new method is to be used for routine measurement, when the practical implementation is to be modified, when the method is to be used for quality control in a pharmaceutical laboratory, or when it is to be used for cleaning validation.
Validation of a method is mandatory for the release of pharmaceutical products. The steps required for validation are specified by the applicable guidelines, such as ICH Q2(R1).
The essential parameters of a validation are:
- Limit of detection and quantification
However, depending on the nature and purpose of the method, it may not be possible to validate all parameters.
Our experts at Reference Analytics have considerable know-how in carrying out verifications, validations and transfers and can also provide comprehensive consulting services to help with questions.