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This book details the essential principles and practices for ensuring pharmaceutical quality during manufacturing and inspection. It serves as a comprehensive guide for regulatory bodies and pharmaceutical manufacturers, outlining the critical elements required for compliance with international standards. The text focuses on the systematic approach to quality assurance, covering facility design, personnel training, process validation, and documentation necessary for producing safe and effective medicines.
The World Health Organization's publications on pharmaceutical quality are widely regarded as authoritative resources within the global health community. This text, focusing on GMP and inspection, is expected to be a foundational document for regulatory agencies and industry professionals seeking to uphold stringent quality standards in drug manufacturing. Its content is likely to be technical and prescriptive, aimed at ensuring compliance and the safety of pharmaceutical products worldwide.
Page Count:
413
Publication Date:
2007-01-01
ISBN-10:
9241547081
ISBN-13:
9789241547086
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