Quality assurance unit standard operating

Already the Consensus Document on Quality Assurance (OECD No. 4, 1999) had recognised that these two possibilities would not sufficiently describe the real-life inspection activities of a Quality Assurance unit, and the revised GLP Principles have acknowledged this extended view of inspection types. Inspections dealing with the conduct of, and the activities within, a study are now further subdivided into two different types, so that there are finally three types of inspections, which are just named in the OECD Principles, are described in the OECD Consensus Document on Short-Term Studies (OECD No. 7,1999), and which have to be further specified by Quality Assurance Programme Standard Operating Procedures. These three types are ... 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

There are several areas in the GLP guidelines which are more difficult to implement in an academic setting than in other settings. These are requirements for a separate Quality Assurance Unit (QAU) and the responsibilities thereof establishing Standard Operating Procedures (SOP s) and conformance to them as written and the significant added costs of doing business under the GLP s. 

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. 

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