Risk Assessment

Standard Operating Procedure (SOP) for Process Validation

Standard Operating Procedure (SOP) for Process Validation

This SOP on Process Validation provides detailed guidelines for ensuring that manufacturing processes consistently produce products meeting predetermined quality criteria. Covering aspects such as responsibilities, validation steps (IQ, OQ, PQ), documentation, change control, training, compliance, and auditing, it serves as a comprehensive resource for maintaining high-quality standards in various industries including pharmaceuticals, biotechnology, medical devices, and chemicals.

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Standard Operating Procedure (SOP) for Risk-Based Inspection

Standard Operating Procedure: Risk-Based Inspection

This Standard Operating Procedure (SOP) outlines a comprehensive Risk-Based Inspection (RBI) process, prioritizing inspection resources on high-risk areas to ensure safety and operational integrity. It covers roles and responsibilities, risk assessment, inspection planning, execution, analysis, documentation, training, continuous improvement, and compliance.

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Standard Operating Procedure (SOP) for Product Recall

Standard Operating Procedure (SOP) for Product Recall

This Standard Operating Procedure (SOP) outlines a comprehensive process for handling product recalls, covering risk assessment, communication strategies, regulatory compliance, and post-recall evaluation. Essential for maintaining quality control and safeguarding consumer safety, this SOP provides a structured framework for swift and effective recall management.

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"Navigating Risk: Insights from Pharmaceutical QC Professionals through Interviews"

“Navigating Risk: Insights from Pharmaceutical QC Professionals through Interviews”

Explore the nuances of risk management in Pharmaceutical Quality Control (QC) through interviews with industry professionals. Gain insights into risk identification, assessment, and mitigation strategies, along with challenges and future trends shaping the dynamic landscape of QC. Stay informed to ensure product safety and compliance in the evolving pharmaceutical industry.

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