Good Documentation Practice (GDP) AEU00510 ISS 02 05 Feb 2019

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.

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

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.

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.

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.

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.

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