The Lock Box Blog
Our comprehensive guides offer in-depth insights, practical tips, and expert advice to ensure workplace safety and compliance.
Preparing for a Swissmedic Audit: A Comprehensive Guide
Swissmedic, Switzerland's regulatory authority for therapeutic products, audits pharmaceutical and biopharmaceutical facilities to ensure compliance with regulatory standards. Facilities preparing for a Swissmedic audit must focus on critical areas such...
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The Importance of Dryness Post-SIP in Pharma
Table of Contents 1. Introduction 2. Role of Steam-in-Place (SIP) in Sterilization 3. Importance of Dryness After SIP 3.1 Preventing Microbial Contamination 3.2 Maintaining Product Quality 3.3 Ensuring Equipment Longevity...
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When is a Risk-Based CQV Approach Too Risky?
Table of Contents Introduction Overview of Risk-Based CQV Regulatory Emphasis on Risk Management in CQV When is Risk-Based CQV Considered Too Risky? Steps for a Successful Risk-Based Approach Regulatory Perceptions...
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Avoiding the "Check-the-Box" Mentality in CQV
In the world of Commissioning, Qualification, and Validation (CQV), one of the most challenging mindsets to overcome is the "check-the-box" approach, where teams complete tasks simply to meet regulatory obligations...
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The Importance of User Requirements Specifications (URS) in CQV
Table of Contents Introduction What is a User Requirements Specification (URS)? Benefits of a Well-Defined URS 1. Establishing Clear Project Goals 2. Enabling a Science and Risk-Based Approach 3. Streamlining...
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Safety Slide for Drugs on the Job
The Lock Box Safety Moment Slide this week is on Drugs on the Job. Need the powerpoint (pptx) file for your presentation? No problem! Subscribe below and we will send you...
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Safety Slide for Taking a Vacation
The Lock Box Safety Moment Slide this week is on Taking a vacation. Need the powerpoint (pptx) file for your presentation? No problem! Subscribe below and we will send you out...
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Warning Slippery Signs: Improving Safety, Preventing Accidents
Discover the importance of Warning Slippery Signs in reducing workplace accidents and enhancing safety. This blog covers optimal sign placement, design features for maximum visibility, and compliance with safety regulations....
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Managing Construction for Seamless CQV in Pharma Projects
Table of Contents 1. Introduction 2. The Role of Construction Management in CQV 3. System Cleanliness and Its Impact on Commissioning 4. Ensuring Adherence to Regulatory Specifications 5. Strategies for...
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Understanding CQV: Commissioning, Qualification, and Validation
Commissioning, Qualification, and Validation (CQV) are essential processes in the pharmaceutical industry, ensuring that systems, equipment, and facilities are fit for their intended purpose. This blog explores the key phases...
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Integrating Vendor Documentation into CQV: Minimizing Duplication
Table of Contents Introduction Importance of Vendor Documentation in CQV Types of Vendor Documentation Useful for CQV Risk-Based Approach to Vendor Documentation Minimizing Duplication through Vendor Documentation Assessing Vendor Quality...
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Safety Slide for Confined Space Awareness
The Lock Box Safety Moment Slide this week is on Confined Space Awareness. Need the powerpoint (pptx) file for your presentation? No problem! Subscribe below and we will send you out...
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