EC guide to GMP, Ch 3 (Premises and Equipment)

Introduction

As more compounds that are considered to be highly potent enter our manufacturing areas the controls around management and handling becomes increasingly important.

The use of risk assessment has been heavily employed with the aim of assessing operator handling procedures together with increasingly complex calculations relating to cleaning validation.  Ultimately the design, maintenance and use of equipment within our facilities is as important as it ever was.

Some points of interest:

  • Expansion of guidance to avoid cross contamination.  This takes into account recent EMA guidance on dedicated facilities which is also worth a read.

How can you help your fellow members?

  • Do you know how to compile the right factors into a cross contamination risk report?  Do you know who should be involved in working on this with you?
  • Have you been involved in the design of a facility that was intended for compounds where increased risk of cross contamination was a factor?  Importantly, have you been involved when a compound was introduced to your facility and you had to make changes?
  • Members can benefit from your advice in the same way the authors of the guidance can.

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