Quality Risk Management (QRM) Fundamentals

Quality Risk Management (QRM) is an important aspect of the Pharmaceutical Industry as per ICH Q9. Hence, brief details on “QRM” is illustrated here for guidance purpose. Principles of Quality Risk Management (QRM) The Quality Risk assessment (QRM) should...

Safety Health and Environment 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,...

Latest Retention Sample Management 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...

Latest Hold Time Study 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...