Production Documentation

GMP as “Give me More Paper” – everyone working in a GMP-regulated environment has heard that one before. However: “Good documentation prevents the errors of verbal communication and enables traceability,” according to the EU GMP guideline. Good documentation practices are mandatory in the GMP environment.

Here "good" means:
As much as necessary – as little as possible! 

Documentation – Maintaining an Overview 

GMP operations use comprehensive documentation for various purposes in many different ways. The GMP system itself is described in work instructions and SOPs Standard Operating Procedures. Up to several hundred SOPs exist in a GMP operation and require continuous maintenance. Production documents such as batch records, specifications, test instructions, methodology descriptions and technical documents like system documentation, room books, maintenance and calibration instructions, and much more need to be prepared and administered. Consultancy regarding the fundamental layout of such documents and the goal-oriented structuring of professional documentation helps maintain an overview. Professional, reliable documentation can be realised this way. Training employees in good documentation practices completes the services offered.

Less is More – Stemming the Documentation Flood

Missing documents are not the only potential problem during inspections. Too many documents can also lead to findings. This occurs when mastery of the operation over the flood of documents is no longer credible. A targeted analysis helps to remedy this. What documents are missing? What can be omitted? The competent reduction of documents establishes clarity and conserves resources. Streamlining made by gempex.

Writing SOPs Means Redefining Processes

Of course there is no need to reinvent the wheel and document templates are readily available via the Internet today. But not all templates are created equal – the quality of the template contents and right initial selection count! Practical experience is a crucial advantage here. And the template alone is only half the battle. It only provides the matrix, serving as a guideline for the topics that need to be addressed and described. One and the same process can look very different between companies. Preparing an individual, optimum process definition requires analysis, conducting interviews in the operation and defining process steps. Processes can even be optimised in many cases. The result is put on paper with confidence. This creates a streamlined SOP that can also be put into practice.

When the Effort Becomes too Great – gempex is Glad to Take Over!

gempex offers advice on all matters related to professional GMP documentation, supplies templates, prepares analyses and structures, creates documents and provides training. And then? The ongoing administrative effort is simply too much for some operations or organisations. Essential personnel resources are lacking and perhaps there is a maintenance backlog. 

This is where gempex can provide the required resources. Either through experts on site at customer facilities, or by having gempex administer the documents directly in the external GMP office.

Benefits

  • professional templates developed over many years
  • structuring examples and document sets for various operations and multiple fields of application
  • professional process analysis and optimisation
  • an external perspective, state-of-the-art benchmarks
  • paper reduction
  • by request, added resources or external document administration 

Contact Person

Tim Ohlrich
Graduate Biotechnology Engineer (Dipl.-Ing FH)
Senior Consultant/ Manager
Pharmaceuticals/ Biotechnology Department Manager   

t-ohlrich@gempex.com
+49 621 819119-22