Well, the Europeans are at it again, ahead of the U.S. in updating regulations to reflect the changing regulatory environment and expectations. This document will be effective on October 1, 2014. The major changes are summarized as follows:
1. Section 6.12 states that sampling plans used should be appropriately justified and based on a risk management approach.
2. Section 6.13 states that samples should be managed in a manner to minimize the risk of mix ups and to protect the samples from adverse storage conditions.
3. Section 6.7 states that there should be a procedure for the investigation of out of specification and out of trend results.
4. Section 6.37-6.41 addresses technical transfer of test methods, suggesting that a gap analysis be performed and documented to identify any supplementary validation that should be performed, prior to commending the tech transfer process.
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