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

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.

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.

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

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 untilthe

paperwork is released!

Lot no. XYZ

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!

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.

At our company we put patients first. © GMP Training Systems, Inc. ALL RIGHTS RESERVED

FOR PREVIEW PURPOSES ONLY

The FDA

FDA

The FDA representsour customers, the patients.

They inspect our company to ensure that our customers can trust us.

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.

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.

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.

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.

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.

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.

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

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.

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

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.