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How to implement Good Documentation Practices

White paper: How to implement good Documentation Practices This white paper describes the fundamental requirements of good Documentation Practice (GDP) routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the Code of good Manufacturing Practice (GMP). This document was prepared in February 2016, any content including links and quoted regulation may be out of date. Please refer to the appropriate source for the most recent information. We endeavour to keep an up-to-date record of information at 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. MKT_TMP200_01_r06. PharmOut white paper: How to implement good Documentation Practices Why are document standards important? In a GMP environment Documentation needs to meet certain requirements to ensure product quality and product safety. If an instruction or record is poorly documented, then the manufacture or Quality assurance/control of a product can be negatively impacted, potentially reducing patient safety.

PharmOut white paper: How to implement Good Documentation Practices PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@pharmout.net Web: www.pharmout.net ©2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients.

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