Quality Assurance & Quality Control
A batch is released only when it meets its written specification. This page sets out who decides that, and on what evidence.
Standards followed
IP / BP / USP
What happens to every batch
Incoming material check
Actives and excipients are quarantined and tested against specification before they are released to production.
In-process control
Defined parameters are checked and recorded at each stage of manufacture, not only at the end.
Finished product testing
The batch is tested for the parameters set out in its specification, against the applicable pharmacopoeial monograph.
Batch release
A qualified person reviews the complete batch record and test results, and either releases or rejects the batch.
Retention and stability
Retention samples are held for the required period, and ongoing stability samples are pulled and tested on schedule.