Establishment Inspection Report , good

During the inspection, both conditions and procedures should be observed. If a hazard poses an immediate threat, preventative action must be taken right aw, not after the inspection. Notes are made, specifying details of the hazard, including its exact location. When completing the inspection report, it is a good idea to classify each hazard by degree of possible consequences (for example A = major, B = serious, C = minor). In this way, priorities for remedial action are established. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

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