ISO 13485 2016 is here… what now?

PIC/S GMP Documentation Tips

What you need to know about PIC/S GMP Documentation Tips

The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and provides the following PIC/S GMP documentation tips.

Overview of the main changes

Sections relating to documentation and records in PIC/S PE 009-13 (Part 1) have been revised and in some cases expanded to provide clarity on a number of points, including:

  • which documents to retain
  • retention duration
  • location of retention
  • control of retained record integrity
  • responsibility for retention
  • quality or GMP training required.

The new guidance acknowledges that documentation can be paper-based, electronic, photographic, or ‘hybrid’ – a combination of paper-based and electronic. It uses ‘documentation’ and ‘record(s)’ interchangeably. Interestingly now, the term “typed” is the same as “written”, so trying to get everyone on the same “page”, or now “screen”.

A closer look at the changes

Chapter 4, Documentation, contains a new section called Retention of Documents and a couple of other changes. As you read through the new guidance, look out for the following:

There are some sections outside of Chapter 4 that also deal with documentation and we should consider in the blog around PIC/S GMP Documentation tips. Keep an eye out for these points as you read through the new guidance.

Other changes relating to documentation:

Want more?

In addition to this blog on PIC/S GMP documentation tips, we also have blogs on PIC/S version 13 URSs and continuous quality reviews.

For more specifically on documents and quality systems, the following blogs may be of interest:

If you want more hands-on experience, sign up for class room training run by one of Australia’s Leading GMP Consultants or our ever-popular our online GMP training.