Rajesh Kumar Ravichandran

🚀 QC Microbiology Key Testing Techniques & Terminologies Every Pharma Professional Should Know In the pharmaceutical industry, QC Microbiology safeguards product quality and patient safety. Here’s a quick guide to critical techniques and terminologies you’ll often come across in vaccine manufacturing and pharma QC: 🔬 Core Testing Techniques Bioburden Testing → Measures microbial contamination in raw materials or products before sterilization. Sterility Testing → Ensures finished products are free from viable microorganisms. Bacterial Endotoxin Testing (BET) → Detects endotoxins (pyrogens) using the LAL test to prevent fever reactions. Microbial Limit Testing (MLT) → Verifies products meet pharmacopeial microbial limits for safety and quality. Environmental Monitoring (EM) → Tracks contamination in cleanrooms and manufacturing areas via air, surface, and personnel sampling. Growth Promotion Testing (GPT) → Confirms that culture media supports the growth of microorganisms as intended. Antimicrobial Effectiveness Testing → Evaluates the ability of preservatives to prevent microbial growth in pharmaceutical products. 📘 Essential Terminologies CFU (Colony-Forming Units) → The number of viable microbial cells capable of forming colonies. TAMC & TYMC → Total Aerobic Microbial Count and Total Yeast and Mold Count to assess overall microbial burden. Objectionable Organisms → Specific microorganisms harmful or undesirable in certain products. Alert vs Action Levels → Predefined microbial count limits; Alert prompts investigation, Action requires corrective measures. Sterility Hold Time → Maximum time sterile product/components can be held before further processing or testing. Depyrogenation vs Sterilization → Depyrogenation removes pyrogens (endotoxins); Sterilization eliminates all microbial life. Media Fill Simulation → A test using sterile growth media instead of product to validate aseptic manufacturing processes. These techniques and terms form the backbone of QC Microbiology, ensuring pharmaceutical products remain safe, compliant, and effective for patient use. 💬 Question for you: Which QC Microbiology test or concept do you find the most interesting or challenging? #Microbiology #PharmaceuticalIndustry #QualityControl #VaccineManufacturing #Pharma #Biotech #LifeSciences #QC #GMP

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Q.24 - Why c is small in cGMP ? Ans.24 - In "cGMP", the "c" stands for "current", which is not a proper noun.The "c" is written in lowercase to differentiate it from other GMP guidelines that might have been used in the past. *cGMP* stands for *Current Good Manufacturing Practice*. The emphasis on "current" indicates that the guidelines and regulations are subject to change and update as new technologies, methods, and knowledge become available. This ensures that manufacturing practices remain up-to-date and aligned with the latest standards for quality, safety, and efficacy.

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🚀 Goal: Pharmacovigilance Scientist at TCS (Fresh/Entry Level) 1️⃣ Understand the Role At TCS, a PV Scientist typically: ✅ Processes ICSRs (Individual Case Safety Reports) ✅ Performs MedDRA coding and WHO drug dictionary coding ✅ Prepares narratives and case assessments ✅ Uses safety databases (Argus, ArisG, or TCS internal systems) ✅ Ensures compliance with regulatory timelines ✅ Works in shifts depending on client projects. 2️⃣ Core Skills to Build Technical Skills: ✅ Pharmacovigilance fundamentals (case processing, causality assessment, seriousness assessment) ✅ MedDRA & WHO-DD basics ✅ Medical and pharmacological terminology ✅ MS Excel (filtering, sorting, VLOOKUP for handling line listings) ✅ Basics of clinical research & GCP (Good Clinical Practice) Soft Skills: ✅ Attention to detail ✅ Communication (verbal & email clarity) ✅ Time management & SLA awareness ✅ Teamwork & flexibility for rotational shifts 3️⃣ Certifications to Pursue 🎓 Pharmacovigilance certification (Clini India, ICRI, IGMPI, or Udemy specialization) 🎓 Clinical Research Fundamentals 🎓 Medical Writing (optional but helpful) 4️⃣ Steps You Can Take Now ✅ Focus on pharmacology, adverse event reporting, and ICSR basics during B.Pharm studies. ✅ Complete a certification in pharmacovigilance before final year or immediately after. ✅ Start learning MedDRA coding structure (System Organ Class, Preferred Terms). ✅ Follow PV-related pages on LinkedIn to stay updated on trends. ✅ Connect with professionals like Akash Verma for guidance and mock interview tips. ✅ Practice case scenarios available online to understand real-world PV processing. ✅ Strengthen basic MS Excel skills. 5️⃣ Placement & Application Strategy ✅ Apply during TCS off-campus drive or through Naukri/LinkedIn for PV roles. ✅ Highlight certifications, B.Pharm knowledge, Excel skills, and internships in your CV. ✅ Prepare for HR questions on strengths, teamwork, and willingness for shifts. ✅ Be ready for PV scenario-based questions during the technical round. 6️⃣ Suggested Learning Resources 📘 Essentials of Pharmacovigilance (Textbook for structured learning) 📘 MedDRA official website for basic training modules 🎥 YouTube channels: Clini India, Pharmacovigilance India 🎓 Udemy course: “Pharmacovigilance: A Comprehensive Course” 🖥️ Practice MedDRA coding using case examples available online. 7️⃣ Timeline Suggestion (Based on your current B.Pharm timeline) ✅ Next 3 months: Complete certification + learn MedDRA + Excel practice ✅ Next 6 months: Mock interviews + connect with PV professionals ✅ Apply within your final year and immediately after graduation.

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Basic Calculations for Pharmacists 1. Batch Size Calculation https://lnkd.in/dg94etka 2. Potency or Assay Calculation of API https://lnkd.in/dr_Nm2fJ 3. Batch Yield Calculation https://lnkd.in/dMkBG6sM 4. Machine Capacity Calculation https://lnkd.in/dQR65-cr 5. Blender Occupancy Calculation https://lnkd.in/dirgzYys 6. Tip Speed Calculation https://lnkd.in/diAmdDcg 7. Dwell Time Calculation https://lnkd.in/d7vp-Bkv 8. Impurities Calculation https://lnkd.in/gC-irhTj 9. Mass Balance Calculation https://lnkd.in/dek92p22 10. Cleaning Validation Acceptance Criteria Calculation https://lnkd.in/d88Cq3Ee 11. Signal to Noise Ratio Calculation https://lnkd.in/dqFSQHCf 12. Peak to Vally Ratio Calculation https://lnkd.in/dtDnuc6j 13. Tailing Factor Calculation https://lnkd.in/dtBKT5yx 14. Retention Factor Calculation https://lnkd.in/d7ciHsJz 15. Peak Resolution Calculation https://lnkd.in/dSrRBxfW 16. Molarity and Normality Calculation https://lnkd.in/dayxzYN9 17. Milliequivalents and Millimoles Calculation https://lnkd.in/dXQwajTj 18. Molality and Mole Fraction Calculation https://lnkd.in/dt_2wtNg 19. Drug Dose Calculation https://lnkd.in/drg-_GUr 20. F1 & F2 Value Calculation https://lnkd.in/dpqrrTNb 21. Powder Flow Rate Calculation https://lnkd.in/dfhQMHyq 22. Powder Density Calculation https://lnkd.in/dNkSPjpQ 23. Loss on Drying Calculation https://lnkd.in/dcxFp6Rx 24. Process Capability Index Calculation https://lnkd.in/d2hAw7gD 25. Process Performance Calculation https://lnkd.in/decCHurC 26. Solid Fraction Calculation Formula https://lnkd.in/g3kj-4eP 27. Overall Equipment Effectiveness Calculation https://lnkd.in/gfgNVd3P 28. 10 Important Formulas for a SCM Professional https://lnkd.in/gKf2hrwr 29. Clinical Pharmacy Calculation Formulas https://lnkd.in/gk3jMfRG 30. NAPLEX Calculation MCQs https://lnkd.in/gBiKNRyF

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