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<p id="viewer-foo">Yearly validation of equipment in the pharmaceutical industry is essential to ensure your company follows good manufacturing practices (GMP). This quality-assurance process makes sure that your pharmaceutical company produces high-quality products and operates at full functionality. Validation is also necessary for all manufacturing steps so that each product’s design and quality specifications are predictably and consistently met. Thus, this short guide will discuss the validation of equipment and what factors are part of the validation protocol.</p>
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<h2 id="viewer-9mcc3">What Is Yearly Validation of Equipment?</h2>
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<p id="viewer-8ahi9">Yearly validation of equipment is a process in which you prove that all procedures, techniques, equipment, materials, activities, or computer systems for manufacturing pharmaceutical products will lead to the expected results. Validation is mandatory for quality assurance and by law.</p>
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<h2 id="viewer-2m25n">A Quick Overview of Equipment Validation Protocol</h2>
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<p id="viewer-c3il8">There are certain aspects of equipment validation that you must meet as a manufacturer. Here is an overview of the protocol.</p>
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<h2 id="viewer-da2rt">Design Qualification (DQ)</h2>
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<p id="viewer-o26t">DQ verifies that the equipment’s designs will:</p>
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<p id="viewer-a28dc">· meet the user requirement specifications</p>
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<p id="viewer-dpbsd">· comply with all applicable standards and guidelines</p>
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<p id="viewer-69t52">· comply with validation master plans</p>
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<h2 id="viewer-53q1r">Installation Qualification (IQ)</h2>
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<p id="viewer-2f83n">Installation qualification verifies that the pharmaceutical company has installed the equipment correctly, based on manufacturer recommendations and the user’s approved specifications.</p>
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<h2 id="viewer-619q7">Operational Qualification (OQ)</h2>
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<p id="viewer-1tfkf">Operational Qualification verifies that the equipment operates correctly. It also guarantees that the critical components’ responses are within the desired range and match the intended values.</p>
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<h2 id="viewer-d5b81">Performance Qualification (PQ)</h2>
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<p id="viewer-r1qt">Performance Qualification verifies that the pharmaceutical equipment performs reproducibly and adequately in the intended conditions set for specific preparation processes while using approved methods.</p>
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<h2 id="viewer-40o4s">Cleaning Validation</h2>
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<p id="viewer-4e7ac">Cleaning validation is an integral part of the yearly validation of equipment. It demonstrates that the equipment, and its components that touch finished pharmaceutical products or reagents during the preparation process, are acceptable for the intended purposes. It also verifies that any residues of microbiological, radiochemical, chemical, and cleaning agents are eliminated to the level defined by the cleaning procedure.</p>
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<h2 id="viewer-7f2n7">Process Validation</h2>
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<p id="viewer-12fta">While process validation is not a part of equipment validation, it is necessary for overall quality assurance. It ensures that the quality of each product is consistent.</p>
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<h2 id="viewer-bpa41">Validation Summary Report (VSR)</h2>
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<p id="viewer-ak7b1">A validation summary report is a document that summarizes the whole validation protocol results. It also provides insights into the protocol’s suitability.</p>
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<h2 id="viewer-c44vh">Why Yearly Validation of Equipment Is Important</h2>
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<p id="viewer-1v5uk">Yearly validation of equipment is necessary because it ensures that you produce your finished pharmaceutical products to the appropriate standards. Consistent quality is essential to prevent potential harm to your customers and any lawsuits to your company. Moreover, a change in equipment can significantly impact product quality consistency as the raw material measurements may be slightly inaccurate. Consequently, the manufacturing process may yield a significantly different product.</p>
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<p id="viewer-4op8t">For effective validation of equipment and processes, you must hire a dedicated team specializing in this field. This way, your company can deliver products with safe and high quality.</p>
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<p id="viewer-budkd"><em>For more information on validation of equipment and processes and securing histopathology products, visit us at </em><a href="http://meddbot.com/" target="_blank" rel="noreferrer noopener"><em>Meddbot</em></a><em>!</em></p>
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