Gap Analysis for Regulatory Compliance in Pharmaceutical Industry

For pharmaceutical corporations in the field, compliance is more than just a legal responsibility because it is essential to product safety and patients’ well-being as well as customers’ confidence in the products they buy. Various bodies like the FDA in the United States, EMA in Europe, and WHO at worldwide level outline various policies and standard that firms in the […]

Out of specifications (OOS) in the Pharmaceutical Industry

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 […]