The guide offers a full overview of sterility testing including why the sterility test is such an important requirement for the manufacture of sterile products. It provides some practical steps that will help ensure the standards as set out by the European Pharmacopoeia and GMP are met. The eBook also addresses the role of environmental monitoring programs and how these are critical to successful sterility testing, product quality and business reputation.
Andy Whittard, Cherwell Laboratories’ Managing Director comments: “While we recognise that sterility testing is a critical step in ensuring that pharmaceutical products are safe for human use, we also all know that the test is not perfect. Therefore, we have put together this eBook to offer some guidance and practical steps to overcome the challenges involved with sterility testing. Our guide will help the reader mitigate the risk of sterility test failure for their facility by using better processes and continuous environmental monitoring methods.”
Topics covered within the eBook include: the sterility test principle; what the expectations are within the pharmacopoeia and GMP; key considerations in the sterility testing process; how to tackle a sterility test failure and practical steps to minimise risk of contamination.
With over thirty five years’ experience in manufacturing Redipor prepared media and within environmental monitoring applications, Cherwell has expertise in delivering high quality products and services to their clients. The company is flexible and reactive to the individual needs of its customers and is adept at working with customers to offer bespoke solutions to accommodate customers’ unique needs.
NEW! Revised Environmental Monitoring Process and Validation Guide
How are you going to meet the challenge of the new EU GMP Annex 1?
Our revised and updated guide helps highlight decisions and actions to ensure you remain compliant.