New hire orientation good documentation practice presentation
Documentation in Food Manufacturing In a GMP Environment
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.
Agenda• Definitions• What departments use documents?• Who is responsible for creating documents?• Who is responsible for filling out paperwork?
Overview• We work in an FDA environment• Important Items: what do they mean? GDP FDA GMP SQF
TERMS TO REMEMBER• GMP = Good Manufacturing Practice• GDP= Good Documentation Practice• SQF = Safe Quality Food• FDA = Food and Drug Administration
GOOD MANUFACTURINGPRACTICE• GMP = Required for every employee.• Examples of GMP• Training required for everyone employed in the Food, Drug, Medical Device and other regulated industries
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!
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.
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.
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!
Questions?Please contact your supervisor for anyquestions related to any of the topicsdiscussed in this presentation.Thank you and Welcome to Ainsworth!