1. Good Documentation Practice (GDP)
AEU ISS Feb 2019

2. Documentation
Documentation proves that we have followed our validated processes. It shows we know what we did, when we did it, who it was done by and why it was done. It allows traceability of every decision taken, every action carried out and every product produced. It is a critical part of cGMP. Documentation is only useful if it is 100% accurate. ‘If it’s not written down it’s a rumour….If it’s not signed and dated it’s graffiti’. A quote from an FDA auditor.

3. OUR DEFINITION OF DOCUMENT IS:
Information and it’s supporting medium.
The medium can be paper or electronic.
DOCUMENTS THAT WE COMMONLY USE INCLUDE
Procedures
Work Instructions
Forms
Specifications
Reports & Records

4. DOCUMENTATION
Procedures, Work Instructions, Forms, Specifications etc provide the user with information and / or instruction.
Reports and records provide evidence of activities or events that have been performed and / or achieved.

5. DOCUMENTATION MUST BE
CONCISE
Short, clear and understood by the intended user.
LEGIBLE
Must be clear and easily decipherable.
TRACEABLE
The reader must be able to identify who, where, when and how a document was completed or amended.

6. CONTEMPORANEOUS
Documented at the time the activity was done, or as close as possible to it.
ENDURING
Long lasting and durable.
ACCESSABLE
Easily available / retrievable by the intended user.

7. Golden rules of GDP
All actions MUST be documented! Everything documented MUST be signed and dated! ALWAYS use the dd/mmm/yyyy date format! Changes to paperwork MUST not obliterate the original information. The reasons for any such changes MUST be clear or explained! Never leave spaces or gaps in documents – if no information is required to be entered write ‘N/A’. Always use permanent black ink.

8. Golden rules of GDP REMEMBER AFTER A PRODUCT HAS BEEN SHIPPED
ALL THAT’S LEFT IS THE DOCUMENTATION
IT HAS TO BE CORRECT.