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GOOD DOCUMENTATION PRACTICES “ GOOD DOCUMENTATION PRACTICES AND HOW TO IMPROVE GOOD DOCUMENTATION PRACTICES ”

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Page 1: Good documentation practices

GOOD DOCUMENTATION PRACTICES

“ GOOD DOCUMENTATION PRACTICES AND HOW TO IMPROVE GOOD DOCUMENTATION PRACTICES ”

Page 2: Good documentation practices

GOOD DOCUMENTATION PRACTICES

This Training Presentation 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).

Page 3: Good documentation practices

GOOD DOCUMENTATION PRACTICESWhy 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.

• The GMP regulations from PIC/S, FDA and EU all include mandatory sections on documentation. Documentation provides both:

• Information on when, where, who, why and how to complete tasks, and Evidence proving that the tasks have been completed as they should be.

• Consequently, the standard of documentation within a company can directly impact the level of success in manufacturing quality products that are safe as well as success during audit situations.

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES

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GOOD DOCUMENTATION PRACTICES


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