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January 28, 2025

Standard Operating Procedure (SOP) Determination of Residual Hydrocarbon Content in Pharmaceutical Gases

1. Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the method for the determination of residual hydrocarbon content in pharmaceutical gases used in manufacturing processes. The accurate quantification of hydrocarbons ensures compliance with regulatory standards and maintains the quality of pharmaceutical products. 2. Scope This SOP applies to the analysis of residual hydrocarbon content in pharmaceutical […]

0 3 min read
January 7, 2025

Requirements of FDA for Training in Pharmaceuticals

The pharmaceutical industry operates in a highly regulated environment where adherence to stringent quality and safety standards is essential to ensure the production of safe, effective, and high-quality products. Among these regulations, the U.S. Food and Drug Administration (FDA) places a significant emphasis on employee training. Comprehensive and well-structured training programs are pivotal for maintaining compliance, reducing errors, and enhancing […]

0 4 min read
January 6, 2025

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 […]

0 7 min read