Writing it Down! Keeping Good Records

1. Writing it Down! Keeping Good Records A GMP Training Program

2. GMP Good Manufacturing Practice Regulations developed and enforced by the Food and Drug Administration, an agency of our Federal Government.

3. Great Mounds of Paper? Some may think that GMP stands for Great Mounds of Paper! There’s some truth to that.

4. Our Paperwork is a Product The paperwork we produce is of equal importance to the products we produce. Product = Paperwork

5. QC Can we ship this batch? Not until the paperwork is released! Lot no. XYZ

6. 100 % Accuracy Our customers trust each of us to make sure that our paperwork is 100% accurate. Our customers don’t want us guessing!

7. Our customers are special.We call them patients.

8. FDA The FDA The FDA represents our customers, the patients. They inspect our company to ensure that our customers can trust us.

9. Why is so much paperwork required? • To make sure we know exactly what we did, and when we did it. • To be able to correct mistakes if they happen. • To be able to PREVENT mistakes from happening in the future.

10. Good Record Keeping Tips Here are four record keeping tips for us to remember.

11. Record Keeping Tip #1 Use a non-water soluble pen for writing on any official document. No pencils.

12. Record Keeping Tip #2 Clearly record the data.

13. Record Keeping Tip #2 Take your time and write clearly. • Slow down a little. • Take a deep breath! • Relax your body before writing on a document.

14. Record Keeping Tip #2 Sloppy writing is 100% preventable. A few seconds of composure helps reduce stress too, leading to a healthier you!

15. WJC 26 Jan 2007 Record Keeping Tip #3 There is a proper method for making corrections.

16. Record Keeping Tip #3 No erasures. No correction fluid. No “Post-it” notes.

17. Record Keeping Tip #4 Enter enough details so the document can be understood in the future. “I swear to tell the truth, …”

18. Let’s keep good records! Our customers are counting on us.