Watch Your Batch: Tips for a Smooth Drug Product Release
When it comes to your batch release – whether it’s a drug’s introduction to the market or the return of an existing product – a seamless rollout can save your reputation and minimize overhead costs. Ensuring that you follow standard procedures and protocols is essential in all stages of the process to guarantee success. We’ve gathered some useful tips to help manufacturers coordinate a smooth drug product release, from start to finish:
Avoid routine roadblocks
There are common errors that can interrupt your path to a successful batch release. Typically, this can include Out of Specification (OOS) results, which encapsulate all test results that fall outside the acceptance criteria established in drug master files or by manufacturers. Another common pitfall is breakdowns in instrumentation that aren’t properly calibrated, which can lead to unreliable results.
Compliance with regulations
Failing to meet regulations can severely impact your batch release and can lead to various violations. Regulatory knowledge and careful execution are essential for the production process.
Read this article for more helpful tips on ensuring a smooth drug product release.