Record review

You generally review the plant records after you have finished all of your interviews. The records review includes  

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This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

Master production and control records. 211.188 Batch production and control records. 211.192 Production record review. 

Master Production Instructions Batch Production Records Laboratory Control Records Batch Production Record Review Materials Management General Controls Receipt and Quarantine... 

A retrospective record review of 300 patients with Graves disease and 100 with silent thyroiditis who had undergone thyroid scans showed that the likelihood of lithium exposure was 4.7 times higher in the latter, suggesting a link between lithium and thyrotoxicosis caused by silent thyroiditis (649). 

Documentation and records (systems, specifications, raw materials, intermediates, labeling, packaging materials, master production and batch records, laboratory control records, batch production record review)... 

Maintenance records Application software documentation Data reproduction accuracy Documented verification of process steps Operator identification Data record review by quality control Electronic record/signature type, use, control, and audit trail... 

Qualification results review Deviations status Change record review Qualification status statement Reference documents... 

Finally, QA is the effort taken to ensure compliance with government regulations for the systems, facilities, and personnel involved with manufacturing products. Quality assurance audits will be quite varied in scope to achieve this assurance. These responsibilities include batch record reviews, critiques of product design, process validation activity, and, possibly audits of other departments operations. 

The batch record, one of the most critical operations for a manufacturer, can also be one of the most misunderstood or misused. This chapter will evaluate the regulations for batch records, review the life cycle of batch record development, compare European and U.S. batch record philosophy, examine some supporting documentation, and offer a few practical guidelines for batch records. 

Are changes to the master production record reviewed and evaluated by RA How are changes to the master production record reviewed in relationship to the regulatory filing How are changes reported to the applicable government agency Problems in these areas will reflect seriously on the outcome of the audit. 

If a deviation occurs, it is usually first observed as an OOS or OOT result in the testing laboratory. An exception to this is the observation during production of an operator-related or process-related problem that can be identified and addressed prior to submission of samples to the laboratory (e.g., through batch record review or operator/supervisor observation). 

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