Annual product quality review programme begins
Ergopharm has begun a formal annual product quality review programme, examining each product once a year across every source of data the site holds about it.
The review pulls together what is otherwise scattered: in-process and finished-product results trended across the year, every deviation and its investigation, all changes made, stability results, returns, complaints, and the adequacy of previous corrective actions. Reviewed together, patterns appear that no single batch record would show — a slow drift in dissolution, a recurring cause behind unrelated-looking deviations.
“A year of batches says things that no single batch record can.”
Where a review identifies a trend, it produces an action rather than an observation: a revalidation, a specification tightening, a supplier discussion. Conclusions are tabled at management review, closing the loop between what the data says and what the organisation decides.
The programme follows the content set out for product quality reviews in EU GMP Chapter 1 and forms part of the site's ICH Q10 pharmaceutical quality system.
Key facts
- Frequency
- Annual, per product
- Covers
- Trends, deviations, changes, stability, complaints, returns
- Output
- Actions, not observations
- Governance
- Conclusions tabled at management review