2. Introduction
• Good Documentation Practice is a
Requirement but What does it
Mean???
• Not only is Good documentation a
requirement but it protects our
employees and our company.
3. Agenda
• Definitions
• What departments use documents?
• Who is responsible for creating
documents?
• Who is responsible for filling out
paperwork?
4. Overview
• We work in an FDA environment
• Important Items: what do they mean?
GDP FDA
GMP SQF
5. TERMS TO REMEMBER
• GMP = Good Manufacturing Practice
• GDP= Good Documentation Practice
• SQF = Safe Quality Food
• FDA = Food and Drug Administration
6. GOOD MANUFACTURING
PRACTICE
• GMP = Required for every employee.
• Examples of GMP
• Training required for everyone employed
in the Food, Drug, Medical Device and
other regulated industries
7. GOOD DOCUMENTATION
• Good Documentation Practice
• Set of rules to protect and control what
we do.
• WRITE DOWN WHAT YOU DO OR IT
DIDN’T HAPPEN!
8. SQF
• SQF = Safe Quality Foods:
• Program to audit our facility, people,
processes to be sure we are producing a
safe quality product. Audits occur
annually.
9. FOOD AND DRUG ADMINISTRATION
• Food And Drug Administration: The FDA
regulates many industries including ours.
We are mandated by them to product a
quality product while proving what we
do.
10. Document mistakes
• No one is perfect! We make mistakes. Here is how we deal with
them.
• 1. If you make a mistake, draw a line through your mistake and
write the correct item , date and initial.
• 2. Write a brief explanation of the mistake beside the line out.
• 3. For errors of a wrong number or letter, write “EE” for entry
error.
• Please do not use the following:
• Write over, white out, pencil (blue or black pen only), legible
writing. Remember just because you write it, doesn’t mean no
one will read it!
11. Questions?
Please contact your supervisor for any
questions related to any of the topics
discussed in this presentation.
Thank you and Welcome to Ainsworth!