ISO 9000 is a series of internationally recognized standards that have been developed and published by the International Organization for Standardization (ISO) to guide organizations in establishing and maintaining effective quality management systems (QMS). These standards are based on universally accepted principles of quality assurance and management. The ISO 9000 family aims to help organizations … Read more
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
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
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
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
Chemical degradation of penicillins involves various reactions that can occur under different conditions, leading to the loss of their pharmacological activity. 1. Acid Hydrolysis: Mechanism: Penicillins are susceptible to acid hydrolysis, where the β-lactam ring is opened, leading to inactive degradation products. Conditions: Acid hydrolysis occurs in acidic environments, such as the stomach or acidic … Read more
Penicillin, the most important antibiotic, was first extracted from the mould Penicillium notatum. Subsequently, a mutant of a related mould, P. chrysogenum, was found to give the highest yield of penicillin and is employed for the commercial production of this antibiotic. Penicillin belongs to a group of antibiotics called β-lactam antibiotics. The basic structure of … Read more
Beta-lactam antibiotics are a class of antibiotics characterized by the presence of a beta-lactam ring in their molecular structure. This ring is crucial for its antibacterial activity as it interferes with the synthesis of bacterial cell walls, ultimately leading to bacterial cell death. Beta-lactam antibiotics are generally well-tolerated but can cause allergic reactions in some … Read more
INTRODUCTION Antibiotics, also known as antimicrobial agents, are medications that destroy or slow down the growth of other species of microorganisms. They include a range of powerful drugs used to treat diseases caused by bacteria, fungi, actinomycetes, etc. Or The term antibiotic originates in the word antibiosis (i.e. against life). Antibiotics are chemical substances obtained … Read more
Introduction Clinical Significance of Protein Binding: Protein binding of drugs refers to the reversible interaction between a drug and proteins in the blood, mainly albumin, alpha-1 acid glycoprotein, and lipoproteins. This binding has crucial clinical implications because it directly affects the drug’s pharmacokinetics, pharmacodynamics, therapeutic efficacy, and safety profile. Only the unbound or free form … Read more
