Quality Assurance

Quality Assurance

Unveiling the Essence of Quality Management Systems: A Comprehensive Guide to Ensuring Excellence and Customer Satisfaction

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Unveiling the Essence of Quality Management Systems: A Comprehensive Guide to Ensuring Excellence and Customer Satisfaction Quality is a paramount factor in the success of any organization, regardless of its industry or sector. To consistently deliver products and services that meet or exceed customer expectations, organizations rely on robust Quality Management Systems (QMS). These systems … Read more

Achieving Excellence with Six Sigma: Driving Process Improvement and Quality Assurance

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 Achieving Excellence with Six Sigma: Driving Process Improvement and Quality Assurance In today’s competitive business landscape, organizations strive for excellence in terms of process efficiency, quality assurance, and customer satisfaction. Six Sigma is a data-driven methodology that empowers organizations to identify and eliminate process defects, reduce variability, and drive continuous improvement. By implementing Six Sigma … Read more

HPLC System Software Validation

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HPLC System Software Validation: Ensuring Accuracy and Reliability High-Performance Liquid Chromatography (HPLC System) is a widely used analytical technique in various industries, including pharmaceuticals, biotechnology, environmental analysis, and food and beverage. It allows for the separation, identification, and quantification of chemical components in complex mixtures. While the hardware components of an HPLC system play a … Read more

Auditing in the Pharmaceuticals Industry

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Auditing in the Pharmaceuticals Industry: Ensuring Quality, Compliance, and Safety The pharmaceutical industry plays a critical role in society, providing essential medicines and therapies to improve health and save lives. With the stakes so high, it is imperative to maintain stringent standards of quality, compliance, and safety throughout the pharmaceutical manufacturing process. This is where … Read more

Internal Audit in the Pharmaceutical Industry

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Internal Audit in the Pharmaceutical Industry: Enhancing Governance, Risk Management, and Compliance The pharmaceutical industry operates in a highly regulated and complex environment, with stringent quality and compliance requirements. To ensure the integrity of operations, enhance governance practices, manage risks effectively, and comply with regulatory standards, internal audit functions play a pivotal role. In this … Read more

Pharmacokinetic Principles

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Pharmacokinetic Principles A drug should be able to reach its intended site of action after administration by some convenient route. In some cases, a chemical that is readily absorbed and distributed is administered and then converted to an active drug by biologic processes—inside the body. Such a chemical is called a prodrug. In only a … Read more

Pharmacodynamic Principles

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Pharmacodynamic Principles Most drugs must bind to a receptor to bring about an effect. However, at the molecular level, drug binding is only the first in what is often a complex sequence of steps. Types of Drug-Receptor Interactions Agonist drugs bind to and activate the receptor in some fashion, which directly or indirectly brings about … Read more

UTILITY REQUIREMENTS FOR STERILE PRODUCT MANUFACTURING

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UTILITY REQUIREMENTS FOR STERILE PRODUCT MANUFACTURING Any utility in direct product contact is subject to formal qualification through the confirmation of the quality of the delivered material at each use point. Water-for-injection (WFI) systems are considered the most critical of all, and the qualification period for WFI is the longest and may be as long as … Read more

Checklist for sample preparation

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Checklist for sample preparation Checklist for Do’s Use a heating mantel or burner with glass beads to avoid bumping. Specific gravity – check the temperature during the analysis Weight/ml – avoid air bubbles in the tube. Polarimeter – Avoid air bubbles in the cell. For melting point, powder the substance to fine particles & fill in … Read more

Checklist for sample preparation by U.V. analysis

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Checklist for sample preparation by U.V. analysis Checklist for Do’s for U.V. analysis Cells used for the analysis should be identical and transparent. The solution whose U.V. reading is to be taken should be clear and transparent, it should not contain any foreign particles or fibres. For analysis solvents used should be spectroscopic grade. Where … Read more