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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