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Regulatory Affairs

July 25, 2025

Process Validation In Pharmaceutical: Principles, Types, Case Studies And FAQs

  • By Dr Pramod Kumar Pandey - July 25, 2025

Learn about process validation in the pharmaceutical industry, its principles, types, and key case studies. Understand its importance for ensuring product quality, regulatory compliance, and patient safety.

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July 14, 2025

5 Key Differences Between Qualification and Validation: Learn Quickly

  • By Dr Pramod Kumar Pandey - July 14, 2025

Discover the key differences between qualification and validation in the pharmaceutical industry, including real-world case studies, regulatory insights, and FAQs to ensure GMP compliance

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July 9, 2025

Key Difference Between GMP and cGMP: Learn Easily In 5 Minutes With FAQs

  • By Dr Pramod Kumar Pandey - July 9, 2025

The key difference between GMP and cGMP is that GMP (Good Manufacturing Practices) refers to established guidelines for manufacturing quality products, while cGMP (current Good Manufacturing Practices) emphasises the ongoing implementation of up-to-date technologies, practices, and regulations to ensure product quality and compliance with evolving industry standards. In this blog, I will discuss the key […]

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July 5, 2025

GLP And GMP in Pharmaceuticals: Key Differences, Applications, and 7+ FAQs

  • By Dr Pramod Kumar Pandey - July 5, 2025

Both GLP and GMP are the critical pillars of regulatory compliance. GLP (Good Laboratory Practice) applies to research and development activities, ensuring quality and reliability in testing, while GMP (Good Manufacturing Practice) governs manufacturing processes to ensure product quality and safety. Each GLP and GMP plays a unique role in different phases of drug development-from […]

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June 20, 2025

OOS vs OOT: A Must-Know Guide for Pharma Professionals in 2025

  • By Dr Pramod Kumar Pandey - June 20, 2025

OOS Vs OOT, explore their advantages, and gain insights through case studies and FAQs—essential knowledge for pharma professionals in 2025

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June 18, 2025

What Is Pharmaceutical Audit: Learn In 3 Minutes

  • By Dr Pramod Kumar Pandey - June 18, 2025

Learn what is pharmaceutical audit , why it’s essential, and explore a detailed GMP audit checklist to ensure compliance, quality, and regulatory readiness.

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June 18, 2025

7 Key Differences Between Audit and Inspection In The Pharmaceutical Industry: Learn In 3 minutes

  • By Dr Pramod Kumar Pandey - June 18, 2025

Learn key differences between audit and inspection in the pharmaceutical industry. Learn with a real-life case study, practical insights, and FAQs to ensure compliance and regulatory readiness

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June 18, 2025

What Is Difference Between External Audit and Internal Audit: Explained With FAQs

  • By Dr Pramod Kumar Pandey - June 18, 2025

Learn difference between External Audit and Internal Audit with FAQs

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June 18, 2025

How to Handle FDA Warning Letters: Common Causes, Key Challenges and Proven Solutions with Expert Tips

  • By Dr Pramod Kumar Pandey - June 18, 2025

Learn how to handle FDA warning letters with expert tips, common causes, real case study, and proven compliance solutions to protect your business

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June 18, 2025

The Role of Regulatory Affairs (RA) in Drug Development: From Discovery To Approval

  • By Dr Pramod Kumar Pandey - June 18, 2025

Explore the vital role of regulatory affairs in drug development—from discovery to FDA approval—with insights, key steps, and FAQs

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June 18, 2025

How To Define Specifications of Pharmaceuticals: Learn In 3 minutes

  • By Dr Pramod Kumar Pandey - June 18, 2025

Learn How to design specifications of pharmaceuticals with case studies and FAQs

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June 17, 2025

What is FDA Certificate: Importance, Approval Process, Expert Tips & 5 FAQs

  • By Dr Pramod Kumar Pandey - June 17, 2025

FDA Certificate

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June 17, 2025

Form 483, Form 482, Form 484, EIR, OAI, NAI and VAI: Terms Related To FDA Inspection

  • By Dr Pramod Kumar Pandey - June 17, 2025

Learn about Form 483, Form 482, Form 484, EIR, OAI, NAI, and VAI with FAQs

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June 16, 2025

QMS (Quality Management System) In Pharmaceuticals: Learn In 3 Minutes

  • By Dr Pramod Kumar Pandey - June 16, 2025

Learn QMS (Quality Management System) in pharmaceuticals, it key components with FAQs

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June 13, 2025

Compliance And Data Integrity In Pharmaceuticals: How They Ensure Safety And Success

  • By Dr Pramod Kumar Pandey - June 13, 2025

Learn the importance of compliance and data integrity in pharmaceutical development to ensure drug safety, regulatory approval, and trust

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June 12, 2025

FDA’s Artificial Intelligence Guidelines for Drug Development: Know In 3 Minutes

  • By Dr Pramod Kumar Pandey - June 12, 2025

Learn FDA's Artificial Intelligence Guidelines for Drug Development, covering key regulations, validation processes, ethical considerations, and the future of AI in pharmaceutical innovation

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June 12, 2025

The Crucial Role of Pharmaceutical Regulatory Affairs in Ensuring Drug Safety and Market Access

  • By Dr Pramod Kumar Pandey - June 12, 2025

Learn what is Pharmaceutical Regulatory Affairs and its role in Ensuring Drug Safety and Market Access

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June 11, 2025

Artificial Intelligence (AI) in Drug Discovery and Development: How Helpful Is It

  • By Dr Pramod Kumar Pandey - June 11, 2025

Learn Artificial Intelligence (AI) in Drug Discovery and development, with faster processes, lower costs, and a real-world case study from Insilico Medicine

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March 23, 2025

What Is DMF (Drug Master File): Learn In 11 Minutes

  • By Dr Pramod Kumar Pandey - March 23, 2025

Learn about DMF (Drug Master File), including its types, content, requirements, filing process, and advantages.

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