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QMS(Quality Management)
ALCOA to ALCOA Plus for Data Integrity
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa
Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
Over time, the concept of Alcoa plus has been adopted by various industries, as a framework for ensuring that data
OOS Handle
The objective of OOS investigation should beĀ to identify the root cause of the OOS result Or NSQ results and take appropriate corrective and preventative action. Investigation should include a review of Laboratory testing, review of production and sampling procedures, and will often include additional laboratory testing and Cross functional investigation along with the handling of associated samples and test data
Change Controle
The term change control is used to describe the controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance.
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Pharma Blogs
HOW TO DOCUMENT REACHED METHOD DEVELOPMENT- PHARMA
1. Define the Purpose and Scope Establish the method's objective before you begin writing. Method Title: Assign a descriptive name (e.g., "HPLC Method for the Quantification of Paracetamol in Tablets"). Objective: State exactly what the method achieves. Identify the...
Method Validation Vs System suitability Way to Understand weds story – Pharma
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,...
4 Surprising Truths About 21 CFR: The Obscure Rulebook That Governs Global Medicine
Introduction: Cracking the Code The pharmaceutical industry is filled with complex jargon and acronyms that can be intimidating to outsiders and newcomers alike. One term that frequently appears is "21 CFR," a seemingly cryptic code that holds immense weight in the...
Laboratory Incident Report
Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances (RS) by HPLC Analyst Name: Anil Patel (ID: 5122) I. Incident Description During the HPLC analysis of...
Incident, Deviation,OOS,OOT describes
Detailed Breakdown ā1. Deviation āDefinition: Any departure from a written procedure, standard, or instruction. āTypes: āPlanned Deviation: A temporary, pre-approved change. (e.g., "We are out of Filter A, so we have permission to use Filter B for this batch only.")...
Detailed Regulatory Nuances
1. EDQM / EU GMP (Europe) āFocus: 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). āRisk Management: EU GMP...
OOS AS PER FDA
The OOS FlowchartPhase I: Laboratory Investigation(Did the Lab make a mistake?) [ START: OOS Result Detected ] | v[ Notify Supervisor Immediately...
Description of Incident
The 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)...
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...
More question
HPLC Blogs
HPLC PUMP TROUBLESHOOTING
HPLC (High-Performance Liquid Chromatography) pump issues can significantly impact the performance and reliability of your chromatographic analysis. Here are some common problems and potential solutions: Common Issues: Flow rate inconsistencies: Variations in flow...
“Why Caffeine, Toluene, and B-Naphthol are Ideal for HPLC Column Calibration”
Using compounds like B-naphthol, Caffeine, and Toluene for HPLC (High-Performance Liquid Chromatography) calibration is a standard practice because they are "well-behaved" molecules. They help ensure your system is accurate without the risk of damaging expensive...
HPLC calibration which substance use why ?
B - naphtholCaffeineToluene Whu this use ā¢ Not harm your column ā¢ Easy mixtures like methanol water mix use the mobile phase ā¢ So not harm your column ā¢ Peak are very identical Not use any buffer so no harm in column
Chromatography 621 number chapter adjustment parameters is 8
1) Ph
2) injection volume
3) Temperature
4) buffer Concen
5) Column
6) Mobile phase ratio
7) Wave leny
8)Flow rate
FACTOR AFFECTS ON HPLC COLUMN
1) Partial Blockage of column 2) Adsorption of sample impurities inside column surface. 3) Poorly packed stationary phase. 4) Mechanical or thermal shocks during Handling. 5) Chemical attack on the stationary phase.
HPLC Interview Top 15 Question and answer
1. What is HPLC? Answer:HPLC stands for High-Performance Liquid Chromatography. It is a technique used for separating, identifying, and quantifying components in a mixture. It uses a liquid mobile phase under high pressure to pass through a column containing a...
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Analytical method validation Blog
HOW TO DOCUMENT REACHED METHOD DEVELOPMENT- PHARMA
1. Define the Purpose and Scope Establish the method's objective before you begin writing. Method Title: Assign a descriptive name (e.g., "HPLC Method for the Quantification of Paracetamol in Tablets"). Objective: State exactly what the method achieves. Identify the...
Method Validation Vs System suitability Way to Understand weds story – Pharma
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,...
Laboratory Incident Report
Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances (RS) by HPLC Analyst Name: Anil Patel (ID: 5122) I. Incident Description During the HPLC analysis of...
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...
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...
Uv development
UV development can refer to several distinct areas, primarily revolving around ultraviolet (UV) light and its applications. To provide a comprehensive answer, let's explore these different facets:1. UV Spectroscopy Method DevelopmentThis involves creating and...
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During Job How to Control your selfĀ Blogs
Way of success
Whenever when every morning when if you wake up first smileššš in your face. Then 15 minutes hard exercises. Then 15 minutes yoga. Then 15 minutes time spend your self. Then taken your breakfast š³āš(good nutrition). Then 15 minutes taken Scidual your work Afternoon...
Be healthy
Fighting Interview Fear – Why candidates get nervous during an interview ?
Interview fear is nothing to be ashamed of. In fact, itās natural, stemming from the human desire to seek approval and validation. So, first, when trying to deal with your interview fear, itās important to recognize that interview fear is normalāand have some...