working within GMP
23 years of experience with Verification of the HPLC method
tens of years of HPLC scientific expertise
This approach is typically used for existing analytical methods qualified in a different laboratory when the method is to be transferred from that laboratory (sending laboratory) to a new laboratory (receiving laboratory).
Methods which are not validated at LUNARIA are subject to method transfer prior their use for the quality control analyses. The method transfer consists of method feasibility analyses, to confirm the performance of the method in LUNARIA laboratories, method transfer protocol preparation and approval, method transfer analyses followed by method transfer report.
LUNARIA either prepares own method transfer protocol and report according to our SOP or we incorporate the customer designed protocol and report.
Validation of analytical methods
We offer validation of instrumental and non-instrumental analytical methods, either provided by the customer or developed in-house. Validations are performed in accordance with the ICH/VICH guidelines on validation of analytical procedures (ICH Q2(R1) guideline, VICH GL1 and GL2 guidelines).
In the first phase of the validation, a validation protocol is prepared and approved. The validation protocol contains a description of the validated method, preparation procedures for all reference and test solutions and a detailed list of validation tests together with pre-defined acceptance criteria for individual tests.
In the next phase, validation experiments are performed according to the validation plan. Any deviations or results not fulfilling the approved acceptance criteria are documented and thoroughly investigated.
The results are summarized in a validation report. It compares all validation results to the acceptance criteria and clearly concludes the suitability of the analytical method for the intended purpose.
Verification of the analytical method
We are performing in-house verification of compendial (pharmacopoeial) analytical methods and verification of validated analytical methods which have not been previously qualified (validated, transferred or verified) in LUNARIA.
The verification of an analytical method is performed in order to verify that the given analytical method meets the expected performance under the set conditions of the given laboratory (chemicals, instruments, personnel) and is suitable for its intended purpose.
In the first phase of the verification, a verification protocol is prepared and approved. In the next phase, verification experiments are performed according to the verification plan. Any deviations or results not fulfilling the approved acceptance criteria are documented and thoroughly investigated.
The results are summarized in a verification report. It compares all verification results to the acceptance criteria and clearly concludes the suitability of the analytical method for the intended purpose.
We help our customers with the process validations. We are commonly perform the requested sample analyses (from the process validation phase) and discuss the results.
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Head of QC and R&D