Generation of manufacturing records

Additional supporting documents are also included in the manufacturing records. These may include computerized print-outs from weighing equipment used to dispense chemical raw materials, or recorder charts obtained, e.g. from a freeze-drier upon completion of freeze-drying that batch of product. 

QC records relating to raw materials, in-process and final product are generated in much the same way — by printing/photocopying originals and filling in the test results obtained. 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

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