Quality by Design (QbD) in Pharmaceutical Development

Screenshot 2025 10 20 100943 Quality by Design (QbD) in Pharmaceutical Development

Definition Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. According to the ICH Q8 guideline: “QbD is a systematic approach to development that begins with predefined objectives and emphasizes product … Read more

ICH Stability Testing Guidelines (Q1 Series)

Screenshot 2025 10 18 141959 ICH Stability Testing Guidelines (Q1 Series)

Introduction Stability testing forms the backbone of pharmaceutical product development, ensuring that drug substances and drug products maintain their intended physical, chemical, biological, and microbiological properties throughout the proposed shelf life. The primary objective of stability testing is to furnish evidence on how the quality of a drug substance or product varies with time under … Read more

QSEM and Q-Series Guidelines

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1. Introduction to ICH and QSEM The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays an indispensable role in the global pharmaceutical landscape. Formed in 1990, the ICH emerged from the necessity to bring regulatory authorities and pharmaceutical industry stakeholders together to harmonize the scientific and technical aspects of … Read more

ICH Guidelines: Purpose, Participants, and Process

Screenshot 2025 10 18 121230 ICH Guidelines: Purpose, Participants, and Process

1. Introduction The pharmaceutical industry is one of the most regulated industries worldwide. Medicines and medical products must be safe, effective, and of high quality before reaching the public. To achieve these goals across diverse regions and regulatory frameworks, a unified approach to drug development and approval is essential. Historically, drug manufacturers had to fulfill … Read more

Introduction to Autacoids and Classification of Histamine

Screenshot 2025 10 02 153613 Introduction to Autacoids and Classification of Histamine

Introduction to Autacoids The word autacoid originates from the Greek words “autos” (self) and “akos” (remedy or healing). Literally, autacoids mean “self-remedy” or “self-healing” substances. In pharmacology, autacoids are defined as biologically active chemical substances produced by the body that exert local effects, generally close to the site of their synthesis, and are subsequently metabolized … Read more

Parenteral Products: Production Procedure, Production etc

Screenshot 2025 10 02 143655 Parenteral Products: Production Procedure, Production etc

1. Introduction Parenteral products are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Unlike oral formulations, they bypass the gastrointestinal tract and enter directly into the systemic circulation or localized tissues. Because of this, sterility, pyrogen-free status, particulate-free nature, isotonicity, and safety are critical quality attributes. Parenterals … Read more

Parenteral Products: Definition, Types, Advantages, and Limitations

Screenshot 2025 10 02 131013 Parenteral Products: Definition, Types, Advantages, and Limitations

Parenteral products are sterile pharmaceutical preparations intended for administration by injection, infusion, or implantation into the body. These products bypass the gastrointestinal tract, making them essential for patients who cannot take medications orally due to various medical conditions. The term “parenteral” is derived from the Greek words para (beside) and enteron (intestine), meaning that the … Read more

International Conference on Frontiers in Pharma

📅 Date: 29th – 30th September 2025 📍 Venue: F2 Auditorium, Amity University Uttar Pradesh, Noida, India About the Conference The pharmaceutical industry is currently witnessing a paradigm shift driven by technological innovation, artificial intelligence (AI), nano-engineering, and genomics. To explore these exciting frontiers, Amity Institute of Pharmacy, Amity University Uttar Pradesh (AUUP), with the … Read more

Artemis Hospitals, Gurgaon Job

Greetings from Artemis Hospitals! Artemis Hospitals, Gurgaon, a flagship healthcare institution renowned for its excellence in patient care and advanced medical practices, is expanding its team of highly skilled professionals. We invite passionate, committed, and qualified nursing professionals to join us in our mission of delivering world-class healthcare with compassion, precision, and integrity. At Artemis, … Read more