Unexpected Turns in Validation

Managing expectations in process validation, especially when proving the absence of risks, can lead to some intriguing scenarios. It's not always straightforward to validate a specific claim; at times, you need to craft a unique strategy tailored to the specific situation.

Take, for instance, an experience where I had to demonstrate that a dry composition maintained its consistency over time. The client was primarily concerned with how long the material had been stored. Yet, in assessing the risk factors to its uniformity, the duration of storage wasn't the primary concern. The real issue was the potential for movement of the container holding the powder. Such movements could cause vibrations, possibly resulting in the powder layers separating.

Therefore, our validation strategy centered on the risk of vibrations from movements, rather than solely focusing on the passage of time. This approach was later confirmed as technically sound, and with this rationale accepted, we were able to successfully resolve the issue.

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