Manufacturers of Drug Products require analytical testing to assess the quality and purity of these products for use in humans. With our proven track record of success on optimization of existing research methods, full development and validation studies, and transfer of previously validated methods, we offer the best expertise in our field to support your needs.
Method Feasibility, Qualification and Validation
Eurofins BioPharma Product Testing Netherlands support customers at various stages of the development / validation process. With our proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods, we offer the best expertise in our field to support your needs.
Method Feasibility
When methods are submitted for qualification or validation, we recommend performing feasibility prior to proceeding. Feasibility allows us to gain familiarity with the method and evaluate the method for attributes such as precision, linearity, accuracy and specificity, avoiding protocol acceptance criteria failures.
Method Qualification
Mainly performed on methods supporting early phase products, with a Method qualification, we ensure that the method is appropriate for its intended use.
Method Validation
Generally performed on methods supporting later phase products, methods should be validated as consistent with the USP general chapter and the ICH guidelines. Validation is performed under the direction of a protocol.
Protocol Writing for
Method Transfer Studies
The formal transfer of a test methodology is a required GMP process that qualifies a receiving laboratory to utilize a method that originated in a transferring laboratory. This process is intended to ensure and document that the method is performed as intended within the receiving laboratory environment.
Eurofins BioPharma Product Testing Netherlands offers advantages over other contractors in providing ICH based protocol writing support as well as maintaining a large breadth of testing capabilities and capacity, using the latest technologies, to support the method transfer process.
Types of Transfers
Eurofins BioPharma Product Testing Netherlands works closely with clients to determine the most appropriate strategy for an efficient method transfer. Our approach is based on regulatory guidance combined with a risk analysis. Transfer options typically include:
- Comparative Testing – This is the most common approach and requires the testing of homogeneous lots of material by the sending and receiving laboratories. The transfer protocol will stipulate the details of the procedure, the samples that will be used and the acceptance criteria.
- Co-validation – When multiple laboratories are required for GMP testing covalidation between two or more laboratories is the most efficient transfer strategy. In this case, the receiving laboratory is part of the validation team and performs the intermediate precision experiments to obtain data for the assessment of reproducibility.
- Revalidation – In cases where the transferring laboratory is unavailable for comparative testing, revalidation is often the best option. Under this option, a risk based approach is used to determine which elements of the original validation will be repeated by the receiving laboratory.
- Transfer Waiver – A transfer may be omitted based on the experience of the receiving laboratory (current use of a procedure on another product, transfer of personnel, etc.) or the procedure being transferred is in the USP-NF. Verification should apply in this case.
Recommendations for a Method Transfer project
The degree of success for a method transfer is often proportionate to the degree of collaboration between the client and the contract testing laboratory. We work closely with all parties involved to provide an efficient, timely and cost effective transfer:
- The transferring lab should provide a copy of the method and validation report early for initial discussions.
- Both parties should build time into the project for feasibility (familiarization) to allow the receiving laboratory to gain familiarity with the new method(s) prior to execution of the formal protocol.
- The transferring laboratory must work closely with the receiving laboratory and use their experience to develop a risk-based approach for the transfer.
Please contact us to discuss your needs.
Why choose Eurofins BioPharma Product Testing Netherlands
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multi-disciplinal organization.
- Quick turnaround time on feasibility assessment of the methods, execution of the protocol and generation of the final report.
- A flexible process that allows out-of-the-box thinking and solution driven.
