MD/MV/Transfer Protocols/Reporting and Working on projects at your site
A typical scenario in working with WPBAD on a method development/validation/transfer Project:
1) Agreeing on interest to work with each other, signing a confidentiality form, audit activities
2) Key researchers describes a methods development/transfer/validation project to WPBAD either in a face-to-face meeting or in a conference call
3) Quotations and acceptance of project by pharma/biotech customer and WPBAD
4) Full disclosure meeting with all acceptance criteria and exact requirements done up front to determine critical processing parameters, targets and ranges
5) Clarify in-process and finished product specifications
6) Understand roles and responsibilities for individuals on the team
7) Establish the documentation trail for a technology transfer process
8) Work commences at your laboratory site and progress meetings 1x/week during project in person at site
9) WPBAD examination/signing off on lab data and report by lab supervisor, QC, and QA
10) Report/data submission and transfer of laboratory data to customer
11) Report acceptance and post project follow-up
During method development parameters will be investigated to assure a validatable method outcome and a well documented report. Prior to initiating a validation study, a well-planned validation protocol should be written and reviewed for scientific soundness and completeness by qualified individuals. The protocol should describe the procedure in detail, and should include pre-defined acceptance criteria and pre-defined statistical methods. Following approved by the appropriate corporate and Quality Control authorities, the protocol should be executed in a timely manner. A typical assay validation will require the preparation of product placebo(s), standards, and many samples.
Subsequent to the execution of the method validation protocol, the data must be analyzed with results, conclusions and deviations presented in an official validation summary report. Provided the pre-defined acceptance criteria are met, and the deviations (if any) do not affect the scientific interpretation of the data, the method can be considered valid. A statement of the method's validity should be placed at the beginning of the final summary report, along with the signatures and titles of all significant participants and reviewers.
In the final analysis, the purpose of validating methods is to ensure the procurement of high quality data. After all, if the quality of data is questionable, no meaningful conclusions can be reached about the quality of the product - which will have seriously detrimental effects on stability study data reviews, process validation data reviews, and annual batch reviews, to name a few. Time invested in validating analytical methods in the beginning pays big dividends in the long run. We are not a typical contract laboratory - we work under contract at your site and provide validated, reproducible results in a much faster time frame!
Additionally, WPBAD provides protocol/report writing, method transfer services and training...we can help!