by ramesh | Jul 28, 2022 | Pharmaceutical Guidance
GLP SOP is essential for Pharmaceutical Industry in order to maintain Current Good Manufacturing Practices (cGMP). GLP is also known as “Good Laboratory Practices”. Good Laboratory Practice SOP (GLP SOP) Herein Good Laboratory Practice SOP (GLP SOP) is...
by ramesh | Jul 16, 2022 | Pharmaceutical Guidance
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...
by ramesh | Jul 16, 2022 | Pharmaceutical Guidance
Analytical Method Transfer Guidance is required for Pharmaceutical Industry for the Harmonization of the procedures (SOP). Method Transfer is also calling as “Analytical Method Transfer”. The Analytical method transfer (AMT), or “Technical Transfer...
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...
