Unit 1

ISO 14000: Overview, Benefits, Elements, and Steps

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ISO 14000: Environmental Management Systems Overview of ISO 14000 The ISO 14000 series is a set of international standards and guidelines developed by the International Organization for Standardization (ISO), specifically focused on environmental management systems (EMS). These standards provide a structured framework for organizations to systematically manage and improve their environmental performance. The primary aim … Read more

ISO 9000: Overview, Benefits, Elements, steps for registration

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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

Quality by Design (QbD) in Pharmaceutical Development

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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)

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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

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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

Total Quality Management (TQM)

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1. Introduction to Total Quality Management Total Quality Management: In today’s hyper-competitive global market, where customer expectations are ever-evolving and regulatory pressures are mounting, quality is not merely an operational requirement—it is a strategic imperative. This is especially true in industries such as pharmaceuticals, healthcare, biotechnology, aerospace, and manufacturing, where a small deviation from quality … Read more

Quality control, Quality assurance and GMP

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quality control

1. Introduction to Quality control Quality control: The pharmaceutical industry is a cornerstone of modern healthcare systems, entrusted with the monumental responsibility of delivering high-quality, safe, and efficacious therapeutic agents to patients worldwide. In this highly regulated environment, the importance of maintaining stringent standards cannot be overstated. Three foundational concepts—Quality Control (QC), Quality Assurance (QA), … Read more