This document discusses good documentation practices for the pharmaceutical industry. It explains that documentation needs to meet certain standards to ensure product quality and safety. Poor documentation can negatively impact manufacturing and quality assurance, potentially reducing patient safety. The regulations from PIC/S, FDA, and EU all include mandatory sections on documentation, as it provides information on tasks and evidence that tasks were completed properly. Following good documentation standards can help companies successfully manufacture quality, safe products and improve audit outcomes.

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

2. 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).

3. 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.
• 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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