Wet Lab Analysis

GMP new update came out on the 25th of August 2022.

by | Dec 17, 2022 |

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use - Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft left many people operating in the...

What is polarize light?

by | Dec 12, 2022 | ,

Polarized light waves are light waves in which the vibrations occur in a single plane. The process of transforming unpolarized light into polarized light is known as polarization. There are a variety of methods of polarizing light. Instruments...

RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES

RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time of...
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QMS – CAPA MODULE

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...
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Out of specification top  five questions and answers pharma

Can we average an OOS result with passing retest results to get a passing average? A: Absolutely not. Both FDA and MHRA guidelines strictly prohibit averaging an OOS result with passing retests to "hide" the failure or bring the batch into compliance. Averaging hides...
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Strategic Guide: Managing OOS Investigations in Pharmaceutical Quality Control with real example

oos

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Optimizing HPLC Analysis for Pharmaceutical Quality Control

In the competitive landscape of modern pharmaceutical companies, ensuring precise product quality isn't just a regulatory requirement—it is the foundation of patient safety. At the heart of this quality assurance is HPLC analysis (High-Performance Liquid...
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jobs outside of India requires looking at specific global platforms

Finding pharmaceutical jobs outside of India requires looking at specific global platforms that specialize in life sciences. Since you have experience in Quality Control (QC), you can find many opportunities in manufacturing hubs like the USA, Europe (Germany,...
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Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development

FTIR METHOD DEVLOPMENT Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development because it provides rapid, sensitive, and eco‑friendly characterization of pharmaceutical substances, excipients, and formulations. It is especially...
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HPLC columns classification

HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the “L” designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...
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OOS AS PER FDA

The OOS FlowchartPhase I: Laboratory Investigation(Did the Lab make a mistake?) [ START: OOS Result Detected ]          |          v[ Notify Supervisor Immediately...
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Specificity analytical method validation creative way to understand

Specificity analytical method validation creative way to understand Imagine analytical method validation as building a highly specialized "detection machine" for a specific target. Specificity is about ensuring your machine only detects your intended target and...
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