Annex 1 Utilities
9 Key Areas for Utilities: Annex 1 proposed changes to provision of Utilities
At Honeyman, our aim is keep our clients up to date with all the current regulatory requirements as well as providing an impartial view on future changes that might affect you.
As we communicated earlier in February via our e-news bulletin, there are a significant amount of proposed changes to Annex 1 of the EU GMP.
In this edition we highlight the EU GMP proposed changes to Annex 1 Section 7 Utilities:
The new section on utilities includes the following changes for water systems
- Use of risk assessment is required to define high risk utilities
- Regular analysis on critical parameters for high risk systems
- Water for injections should now be produced from purified water
- Water Flow should remain turbulent through the pipes to prevent microbial adhesion
- New requirements for piping systems
- Additional requirements for Vent filters on Storage Tanks
- New requirements for system sanitisation
- New requirements for sampling and the use of continuous monitoring systems.
- New requirements for feed water quality to steam generator
During our up and coming Pharmaceutical Water: Principles in Practice® course, our experts will discuss the changes in more detail, provide impartial views on the changes and offer a round the table discussion with all delegates to generate a greater understanding.
If you wish to find out more about our Pharmaceutical Water: Principles in Practice® course, please click here or contact us on +44(0)1833 690101 and ask to speak to one of our training consultants.
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