In the pharmaceutical industry, Out of Specification (OOS) means a value that is either higher than or lower than a specified limit set under any regulatory documents, manufacturing procedure or quality control process. OOS results bring various consequences of poor product quality, imperiled patient safety, and noncompliance with regulatory requirements. For this reason, any form of OOS must be dealt […]
1. Objective 1.1 The intention of this procedure is to facilitate the creation of best practices as to the right approach with regard to sampling during process validation. It embraces types of sample, sampling and sample collection, sample handling, analysis, documentation, and reporting that are critical in establishing product quality as well as compliance to regulatory requirements. 2. Scope 2.1 […]
Pharmaceutical validation is crucial for product quality and patient safety. Explore the Importance of Validation in Pharmaceuticals and optimize your validation process.
