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Method validation pharma environment
Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for many years. What is the ICH?: The International Conference on Harmonisation (ICH) started in 1990. It is a group where regulators…
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 valuable for fingerprinting Active Pharmaceutical Ingredients (APIs) and validating methods without the need for solvents. — …
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Method Validation Vs System suitablity Way to Understand weds story
What a Wedding Day Can Teach You About Perfect Lab Results1. Introduction: The Universal Language of AnalogyHave you ever felt locked out of a conversation by technical jargon? Science, in particular, can feel like an intimidating world of its own. But the truth is, even the most complex ideas can be unlocked with a simple key: a powerful, relatable story.The secret to understanding a critical…
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Detailed Regulatory Nuances
1. EDQM / EU GMP (Europe) Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). Risk Management: EU GMP explicitly ties deviation handling to ICH Q9 (Quality Risk Management). You must categorize deviations (e.g., Minor, Major, Critical)…
Description of IncidentThe High-Performance Liquid Chromatography (HPLC) sequence was interrupted unexpectedly during a scheduled run.Analysis in Progress:
A sequence of 15 samples (ID: LIR-20251123-A) was being run for the quantitative analysis of [Specify Compound/Analyte] in [Specify Matrix, e.g., pharmaceutical tablet, environmental water sample]. The sequence included standards, blanks, and quality control (QC) samples.Point of Interruption: The interruption occurred during the analysis of the 7th sample (ID: LIR-20251123-A-07), approximately 3…
Analytical method validation other concepts
Understood. “Analytical image method validation” refers to the process of ensuring that image-based methods used for quantitative or qualitative analysis consistently produce reliable, accurate, and fit-for-purpose results. This is crucial in fields like pharmaceuticals, materials science, environmental monitoring, and medical diagnostics, where image data drives critical decisions.Here’s a…
Uv analysis sop in pharma
This sounds like you’re looking for a Standard Operating Procedure (SOP) for Ultraviolet (UV) analysis. Here’s a general outline of what a comprehensive SOP for UV analysis would typically include. Keep in mind that the specific details will vary depending on the instrument model, the type of analysis being performed, and your laboratory’s quality system requirements.1. Objective: * Clearly state…
Specificity analytical method validation
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:“Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.”This means that a specific analytical method should be able to measure the target analyte accurately…
