Standard operating procedure bioanalytical reports

A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or standard operating procedure (SOP). All experiments used to make claims or draw conclusions about the validity of the method should be presented in a report (method validation report). 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

Cross-validation is discussed by Viswanathan et al. [2] in the report from the 2006 Crystal City III AAPS workshop/conference Cross-validation procedures and acceptance criteria need to remain flexible considering the various bioanalytical situations where it would be (may be) required. Specific cross-validation criteria should be established a priori in a standard operating procedure (SOP). ... 

Standard Operating Procedures The bioanalytical report should include a brief description of critical SOPs (e.g., acceptance criteria for batches and repeat analysis). As appropriate, SOPs should be included as report appendixes. SOP deviations and their impact on the integrity of the study results should be described. 

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See also in sourсe #XX -- [ ]

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