by ramesh | Aug 6, 2022 | PharmaeliX
Good HPLC Practices are considered to be Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). A detailed procedure has been given below to maintain High-Performance Liquid Chromatography Instruments. Waters HPLC Instrument is shown in the image...
by ramesh | Aug 6, 2022 | Pharmaceutical Guidance
Validation is a term widely used in all manufacturing industries. However, it is the most important aspect of the Pharmaceutical Industry. In the pharmaceutical industry, it refers to the process of demonstrating and documenting that a specific process, equipment,...
by ramesh | Aug 2, 2022 | Pharmaceutical Guidance
Pharmaceutical water refers to purified water used in the pharmaceutical industry for the manufacture of pharmaceutical products. It is an essential ingredient in many pharmaceutical products, and is used for a variety of purposes, including washing, mixing, and...
by ramesh | Aug 2, 2022 | Interview Questions, Pharmaceutical Guidance
Quality Control Definitions and Terms are useful and essential for every pharmaceutical scientist or employee. Quality Control Definitions and Terms Herein the list of Terminology and Definitions Used in Quality Control is provided as Guidance. Amorphous A term used...
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...
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...
