by ramesh | Jul 16, 2022 | Pharmaceutical Guidance
Safety Health and Environment (SHE / EHS) refers to the principles and practices aimed at ensuring the safety, health, and well-being of employees, as well as the protection of the environment and surrounding communities. This encompasses a wide range of areas,...
by ramesh | Jul 15, 2022 | Pharmaceutical Guidance
Retention Sample Management is an important aspect of the Pharma Industry to meet cGMP requirements (ICH Q7). It is also called a Reserve Sample / Control Sample. Handling of Retention Sample A retention sample refers to a portion of a product that is kept for later...
by ramesh | Jul 15, 2022 | Pharmaceutical Guidance
Hold Time Study Guidance is essential for Pharmaceutical Industry to meet the cGMP requirements. Hence the Guidance is provided at PharmaeliX. Here in the Holding study of Products described here. This is for your information only (Guidance). Hold Time Study...
by ramesh | May 24, 2022 | Pharmaceutical Guidance
Incident Investigation Reporting is an important aspect of the Pharmaceutical Industry. Herein are the brief details of “Incidents/ Deviations, reporting, Investigation, Correction, Corrective Action and Preventive Actions, and Closure” discussed below....
by ramesh | May 19, 2022 | Pharmaceutical Guidance
Corrective and Preventive Actions (CAPA) / Corrective Action and Preventive Action are important aspects of the Pharmaceutical Industry to meet regulatory requirements. Hence, it is an essential requirement for continuous improvement. Herein we are providing complete...
by ramesh | Mar 4, 2022 | Pharmaceutical Guidance
The key functions of Quality Control department in the Pharma Industry are defined here for better clarity and guidance. Quality Control Laboratory is the heart of any Pharmaceutical Industry. Key Functions of Quality Control The laboratory (QC) is required to perform...
