1. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Writing it Down! Keeping Good Records A GMP Training Program

2. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY GMP Good Manufacturing Practice Regulations developed and enforced by the Food and Drug Administration, an agency of our Federal Government.

3. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Great Mounds of Paper? Some may think that GMP stands for Great Mounds of Paper! There’s some truth to that.

4. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Our Paperwork is a Product The paperwork we produce is of equal importance to the products we produce. Product = Paperwork

5. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Can we ship this batch? QC Not until the paperwork is released! Lot no. XYZ

6. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY 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. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Our customers are special. We call them patients.

8. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY The FDA FDA The FDA represents our customers, the patients. They inspect our company to ensure that our customers can trust us.

9. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY 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. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Good Record Keeping Tips Here are four record keeping tips for us to remember.

11. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Record Keeping Tip #1 Use a non-water soluble pen for writing on any official document. No pencils.

12. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Record Keeping Tip #2 Clearly record the data.

13. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY 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. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Record Keeping Tip #2 A few seconds of composure helps reduce stress too, leading to a healthier you! Sloppy writing is 100% preventable.

15. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Record Keeping Tip #3 There is a proper method for making corrections. WJC 26 Jan 2007

16. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Record Keeping Tip #3 No erasures.No correction fluid.No “Post-it” notes.

17. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY “I swear to tell the truth, …” Enter enough details so the document can be understood in the future. Record Keeping Tip #4

18. At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED FOR PREVIEW PURPOSES ONLY Let’s keep good records! Our customers are counting on us.