Quality assurance unit compliance documentation

The study director is a formal appointment and a key management function for each study. This position is responsible for the scientific conduct of the study as well as for the interpretation, analysis, documentation, and reporting of the result. This person works very closely with the quality assurance unit (QAU) to assure the study is in compliance with GLP. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Batch documentation is an important factor. Preparation of master batch records in accordance with plant standard operating procedures (SOPs) should be followed by an approval of the document by the sponsoring division, usually the formulator or process development staff of the R D unit. On completion of a batch, review of the batch records by the quality assurance group ensures compliance to GMP and that all necessary deviations from and modifications to the manufacturing records are properly explained and documented. 

The quality control unit should review every batch processing order and packaging order issued to manufacture a new batch to assure that these documents are in compliance to the latest monograph. Any change and adjustment in the batch processing order or packaging order should have quality control approval prior to execution of production. 

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