Pharma Interview

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[wemahesh]

summary of global nitrosamine regulations FDA, EMA, ANVISA, SWISSMEDC, HEALTHCANDA.

* Nitrosamines are trace chemical impurities. * They are classified as probable human carcinogens. * Global agencies require a strict 3-step risk assessment framework. * Manufacturers must evaluate, test, and fix any impurity risks.1. The Global CPCA SystemAgencies use the **Carcinogenic Potency Categorization Approach (CPCA)** to set safety limits. This system groups impurities into 5 categories…

[wemahesh]

job interview in chemistry, an academic interview for admission or research, or a general knowledge interview

Got it — you said “Chemistry interview.” That’s a broad request, so let’s narrow it down. Are you preparing for a job interview in chemistry, an academic interview for admission or research, or a general knowledge interview? Each has a different focus. To give you a concrete idea, here’s a sample of the kind of preparation I can help with:—⚗️ Common Chemistry Interview Questions– Basic concepts:…

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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 occurrence Product/Batch details Area/Department involved Immediate impact assessment Initial containment action 2. DATA…

[wemahesh]

Understanding Analytical Method Validation: Interference and Specificity

Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn’t being ‘fooled’ by other things in the mixture. ​Case 1: (Specificity / No Interference) Like a clear road, the signal you are looking for passes through without being blocked or…

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[wemahesh]

Acid base titration explain points cover

The Arrhenius TheoryThis theory is based on the production of ions in aqueous (water) solutions.An acid is defined as a substance that releases hydrogen ions (H+) when it is dissolved in water.A base is defined as a substance that releases hydroxide ions (OH-) when it is dissolved in water.A neutralization reaction is viewed as the combination of H+ and OH- to form water (H2O). The Brønsted-Lowry…

[wemahesh]

What is call Liniarity

The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.What is call Liniarity

[wemahesh]

How to Manage Your Diet and Mental Health in Shift Duty

Working irregular hours can take a massive toll on the human body. When the natural circadian rhythm is disrupted by rotating schedules, both physical metabolism and psychological well-being are significantly impacted. However, with the right structural changes, health can be effectively maintained. Below is a practical blueprint designed to help professionals thrive while working…

[wemahesh]

Troubleshooting Retention Time Shift in HPLC: Causes, Solutions, and Best Practices

If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating moment when the peaks start drifting. Suddenly, you are dealing with:System suitability failuresIncorrect peak…

[wemahesh]

Maximizing Efficiency in Modern Quality Control Labs

Operational excellence is demanded by modern quality control laboratories. Every single day, high testing volumes are managed by laboratory analysts. Accuracy must be maintained during complex testing procedures, including HPLC analysis and Karl Fischer titration. When workflows are optimized, regulatory compliance is easily achieved by pharmaceutical professionals.The Importance of Process…

[wemahesh]

HPLC troubleshooting related RT

Fluctuating retention times Unstable Pressure, check pressure section If mobile phase is not pre-mixed, there could be problem with the ratio been properly mixed(Inconsistent on-line mobile phase mixing) Unstable Column temperature Increasing Retention Times Decreasing Flow rate Decreasing column temperature Decreasing Retention Times Increasing flow rate Increasing column temperaHPLC…

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Global Regulatory PulseWeekly Regulatory Highlights (June 1–3, 2026) 

🇺🇸 FDA Updates CAVHANZA (nilotinib) approved (June 2, 2026) for Ph+ chronic myeloid leukemia with improved formulation allowing use alongside PPIs/H2 blockers without restrictions. Ensitrelvir (Xocova) approved (May 29, 2026) as the first oral option for COVID-19 post-exposure prophylaxis. Zaynich (cefepime + zidebactam) approved (May 29, 2026) for complicated urinary tract…

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Key FDA Updates (Late May–Early June 2026)

The FDA’s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming regulatory decisions on therapies for COVID-19, urinary tract infections, smoking cessation, and kidney disease. These developments highlight both immediate consumer safety concerns and major advances in oncology and infectious disease treatments.”)  —🔑 Key…

[wemahesh]

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…

[wemahesh]

Key Pharmacopoeia Updates 2026

These updates are quite significant because they reshape compliance expectations across different regions and therapeutic areas. Let me break down where the impact is most pronounced:🌍 Key Pharmacopoeia Updates– Indian Pharmacopoeia 2026    – 121 new monographs, especially in anti-tubercular, anti-diabetic, and anti-cancer drugs.    – First-time inclusion of blood component monographs for…

[wemahesh]

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 This procedure applies to all CAPAs arising from all GxP activities within the organization including manufacturing, QC, QA,…

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Audit Trail Features pharma, life sciences

🚀 Building Compliant LIMS Software: Key Audit Trail FeaturesDesigning a pharmaceutical LIMS requires a relentless focus on data integrity, 21 CFR Part 11 compliance, and ALCOA+ principles. Here are the core audit trail features I’m prioritizing for our software modules:Immutable Metadata Logging: Automatically capturing the “Who, What, When, and Why” for every data entry, ensuring logs can never…

[wemahesh]

The International Council for Harmonisation (ICH) Q4 series is a milestone in global regulatory collaboration. 

🌍 Harmonizing Pharmaceutical Quality Testing: ICH Q4 GuidelinesThe International Council for Harmonisation (ICH) Q4 series is a milestone in global regulatory collaboration.  🔹 Core Guideline (Q4B): Establishes the process for evaluating pharmacopoeial texts across the US, EU, and Japan. Once deemed equivalent, these methods are officially interchangeable.  🔹 Annexes (Q4B-1 to Q4B-14): Cover…