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PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
CAPA: Important and Necessary for Devices
There where several topics found by FDA
- Failure to establish and maintain adequate procedures to identify all the actions needed to correct and prevent the recurrence of nonconforming products and other quality problems, as required by 21 CFR 820.100(a)(3)
- Failure to review and evaluate all complaints to determine whether an investigation is necessary and maintain a record that includes the reason when no investigation was made, as required by 21 CFR 820.198(b)
- Failure to establish and maintain adequate procedures to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)
- Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, and include a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 CFR 820.30(c)
- Failure to establish and maintain adequate procedures to confirm that design output meets the design input requirements, as required by 21 CFR 820.30(f).
Outcome
For more detailed information and examples check FDA's Warning Letter. Review your CAPA System!
Source:
FDA/ Warning Letter