SOPs for BA-BE Studies V 2.0

To establish a standard procedure for the preparation, verification, and documentation of mobile phase composition used in LC-MS/MS systems for BA/BE bioanalytical studies.
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To define the procedure for the safe, ethical, and regulatory-compliant disposal of used biological samples, such as blood, plasma, serum, and urine, after completion of analysis in bioavailability and bioequivalence (BA/BE) studies.
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To establish a standardized procedure for receiving, inspecting, and logging biological samples such as plasma or serum received from the clinical site to the bioanalytical laboratory in bioavailability/bioequivalence (BA/BE) studies.
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To define the procedure for documenting and maintaining the storage conditions of biological samples such as plasma, serum, and urine during BA/BE studies to ensure sample integrity and compliance with regulatory requirements.
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To define the procedures to be followed for verifying and ensuring the physical and analytical integrity of biological samples (e.g., plasma, serum) before conducting bioanalytical evaluations in BA/BE studies.
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To define the acceptance criteria for bioanalytical runs and outline the procedure for run review and approval to ensure data integrity and compliance with ICH, FDA, and WHO bioanalytical guidelines.
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This SOP outlines the systematic procedure to identify criteria for rejecting analytical batches and the process to repeat the analysis, ensuring that data quality and regulatory compliance are maintained during bioanalytical evaluations in BA/BE studies.
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To establish a standardized approach for initiating, assessing, documenting, and implementing changes in validated bioanalytical methods used in BA/BE studies, in compliance with ICH, US FDA, and OECD GLP guidelines.
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To establish a procedure for evaluating and documenting the technical competency of analysts involved in bioanalytical activities in BA/BE studies through scheduled proficiency testing in accordance with regulatory expectations.
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To define the procedure for reviewing instrument calibration logs to ensure that all analytical equipment used in bioanalytical studies for BA/BE trials is accurately calibrated and meets performance requirements prior to use.
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