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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…
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…
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,…
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)…
Lupin Limited Ahmedabad interview in 11th June 2023 for Production Department Quality Control Department IPQA etc check now
Hiring for Lupin Limited – Nagpur for Injectable Facility An innovation led transnational pharmaceutical company is looking for bright professionals for its State of art Injectable Manufacturing Facility at MIHAN Nagpur, (Maharashtra) for the following Walk-in Interview @ Ahmedabad Interview Date: 11th June 2023 (Sunday) LUPINpositions: Interview Time: 9.30 am to 3.00 PM Venue – Regenta…
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Pilot batch sample has been taken to stability.
No Only manufacturing area or production batch taken as stability
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Openings for Drug Inspector (55 Posts) in Public Service Commission
The history of Constitution of India reveals that the concept of conducting competitive examination for appointment to certain posts came into consideration way back in the year 1853 and a committee for giving shape to that was constituted under the chairmanship of Lord Macaulay in the year 1854. Later on the Federal Public Service Commission and the State Public Service Commissions were…
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Sun Pharma – Walk-In Interviews For Production / QA/ Engineering / Maintenance / Microbiology
Introduction Sun Pharmaceutical Industries Limited is a leading Indian multinational pharmaceutical company headquartered in Mumbai. The company is known for manufacturing and selling pharmaceutical formulations and active pharmaceutical ingredients in over 100 countries worldwide. Sun Pharma is conducting walk-in interviews for various positions in the fields of Production, Quality Assurance…
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