by ramesh | Nov 13, 2022 | Pharmaceutical Guidance
A stress Study for Stability Guidelines is provided here for Pharmaceuticals Professionals. Stress Study is also calling as Forced Degradation (/Stress Testing). What is Stress Study Stress testing of the drug substance (API) will help to identify the likely...
by ramesh | Oct 31, 2022 | Pharmaceutical Guidance
ALCOA Plus (ALCOA+) is the “Heart and Soul” of DATA Integrity. Data integrity (DI) is an important and Key attribute to ensure compliance with cGMP (Current Good Manufacturing Practice). Full form of ALCOA and ALCOA Plus The ALCOA and ALCOA Plus full form...
by ramesh | Sep 14, 2022 | Pharmaceutical Guidance
Analytical Balance is the most important analytical instrument in the Pharmaceutical Industry. Based on the applications, weighing balances are utilized in different locations such as Quality Control & Manufacturing. Image Courtesy Mettler Toledo Analytical...
by ramesh | Aug 12, 2022 | Pharmaceutical Guidance
Audits and Inspections are so Important for all Industries to improve Quality systems. This will play a major role in the Pharmaceutical industry. Types of Audits and Inspections Based on the category, audits are classified into three (3) for user convenience. The...
by ramesh | Aug 11, 2022 | Pharmaceutical Guidance
Quality Control (QC) is the most important area in the Pharmaceutical industry. Quality Control (QC) in Pharma industry A major part of quality assurance is Quality Control defined by ISO as “the operational techniques and activities that are used to...
by ramesh | Aug 11, 2022 | Pharmaceutical Guidance
Quality Assurance (QA) is a Key department in the Pharmaceutical industry, by monitors, controls, and maintains Product Quality. Quality Assurance (QA) in Pharma Industry To achieve the right quality product, quality should be built into every stage of the process....