QUALITY MANUAL (PART 2 OF 2)
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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Resource Management
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Resource Management
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Resource Management
Infrastructure
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Vendor Evalution
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Validation / Qualification Policy
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Validation / Qualification Policy
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Validation/Qualification Policy
Validation Program
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Validation Program
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Validation Program
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Type of Validation
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Type of Validation
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Product Realisation
Planning of Product Realization
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Material Control On Receipt
Production Planning
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Method, Process And Cleaning Validation
PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
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PRODUCTION/ PROCESS CONTROL
Measurement, Analysis and Improvement
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Measurement, Analysis and Improvement
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Measurement, Analysis and Improvement
Water System
Referance
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Appendix
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Appendix
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Appendix
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Appendix
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Appendix
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Appendix
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Revision History
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