Continued process verification programme established
Ergopharm has established a continued process verification programme, trending routine commercial batches statistically rather than treating validation as something completed once and filed.
Process validation has three stages: design, qualification and — the one most often neglected — ongoing verification. The third stage asks a question the first two cannot: is the process still behaving now as it did when it was qualified? Answering it requires data from routine production, analysed as a series rather than batch by batch.
“Specification tells you whether the batch is acceptable. Trending tells you whether the process is still the one you validated.”
Critical process parameters and critical quality attributes are trended with control limits derived from the qualification batches. A drift within specification but outside the expected distribution triggers investigation before it becomes a failure, which is the entire point.
Findings feed the annual product quality review and, where a shift is confirmed, a revalidation or a process change under change control.
Key facts
- Stage
- Third stage of the process validation lifecycle
- Basis
- Control limits from qualification batches
- Trigger
- Drift within specification but outside expected distribution
- Feeds
- Product quality review; revalidation where confirmed