Practical Implications of GAMP 5
Updates from GAMP 4 to GAMP 5 there have been significant changes in the guidance given for Good Automated Manufacturing Practice.
After reading through the new enhancements to GAMP 5 have you asked yourself:
If I undertake remedial work using GAMP 5 on a system originally validated using GAMP 4 guidance what do I do?
Our GAMP experts would advise:
- Review your URS to identify critical quality requirements for remedial work.
- Draft a validation plan which includes the scope of testing defined from the risk assessment and approach to be followed to verify that the system will remain fit for intended use.
- Critically, GAMP 5 refers to the use of Risk Assessments, if you have 100% probability of Detection, through the use of continuous on line monitoring, why validate your system.
- Perform verification work according to the new GAMP 5 principles.
- Prepare summary reports to close out the remediation process.
Good quality management practices, a risk based approach with more of a reliance on science and more of a focus on the supplier and patient are the main improvements to this guidance manual.
These enhancements are all vital to the future of the pharmaceutical industry. GAMP will continue to support and enhance good manufacturing practices for suppliers, pharmaceutical manufacturers and regulators as we move into the future.
So contact us today with all of your questions and we can help you conform to these improvement in the way your drug development and manufacturing is managed.
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