In the pharmaceutical industry, a quality manual is a critical document that describes the company’s entire Quality Management System (QMS). It serves as a roadmap for ensuring consistent production of safe and effective medications.
A pharmaceutical quality manual is a foundational document outlining an organization’s commitment to quality and compliance. It details the quality management system (QMS), encompassing policies, procedures, and responsibilities. This manual ensures adherence to regulatory requirements like GMP, outlining how products are consistently manufactured, tested, and released. It covers aspects like document control, change management, and deviations, fostering a culture of quality. Risk management and continuous improvement are also emphasized, ensuring product safety and efficacy. The manual serves as a guide for employees, auditors, and regulatory bodies, promoting transparency and accountability across all operations.
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Table of contents
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Table of contents
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Table of contents
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Approval
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Introduction
Quality Management System
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Quality Policy
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Quality Objective
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Product Life Cycle
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Six System Approach
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Production System
Facility and Equipment System
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Laboratories Control System
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Material System
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Packing and Labeling System
Quality System
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General Information
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Responsibility of Quality Assurance Department
Responsibility of Quality Control Department
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Responsibility of Quality Control Department
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Responsibility of Quality Control Department
Document Management
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Document Management
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Document Management
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Document Management
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Document Management
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Document Management
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Document Management
Management Responsibility
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Document Management
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Document Management
Resource Management
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Resource Management
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