BRIEFLY EXPLAINED
Method transfer
High speed in the individual processes and correspondingly fast results are essential factors in the assessment of suppliers of laboratory services.
We at HHAC are aware of the relevance of the time factor in each phase; we are correspondingly efficient in our internal processes and their coordination among our laboratory.
Depending on their degree of complexity, methods can be developed or optimized at our company in the shortest possible time. In order not to lose any time, HHAC as a contractor is able to perform the contract analysis in routine on-site or to transfer the method to the client or another laboratory.
We support our customers from the planning stage (preparation of transfer plans and acceptance criteria) to the final documentation (transfer report), ensure a permanent “hot line” to the customer and thus ensure a rapid and, above all, efficient introduction of the methods into the routine operation.
Our plan for an analytical method transfer
- Objective of the analytical transfer
- Definition of the test methods to be transferred and specifications of the products to be tested
- Definition of the test specifications to be used, with reference to the validation reports available to date
- Description of samples, equipment, reagents, media, reference substances and other working materials
- Definition of who will provide standards, samples and, if applicable, placebo mixtures, and in what form
- Description of the work and tests to be performed
- Agreement of the reporting form for the results
- Establishment of procedures for statistical evaluations
- Establishment of acceptance criteria
The results of the analytical transfers are comprehensively documented. The individual work steps, the results, as well as special observations or deviations from the plan are listed. Furthermore, the report makes a final assessment of the results as well as any deviations found. For this purpose, it evaluates whether the accepting laboratory is qualified for the transferred procedures and can be approved for the tests. The authorization of this report is carried out by our customer.