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Manufacturing

3 Effective Strategies for Validation Specialists in the Pharmaceutical Industry

Validation is crucial in pharmaceutical manufacturing. It minimizes defects and errors, reduces costs, and ensures compliance with regulations. However, validation specialists face challenges, including changing regulations and diverse product categories. In this article, we delve deeper into the realm of pharmaceutical validation, exploring the strategies that validation specialists can employ to ensure the effectiveness of the validation process.

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General

Precision Matters: Why Traceability is Essential for Calibration in Pharma

Accurate measurements are critical to ensure the quality of pharmaceutical products and ultimately impact the health of patients. That’s why calibration is an essential aspect of the manufacturing process.

Our latest article discusses the importance of traceability in calibration and how it ensures reliable and accurate results.

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General

The Importance of Authorisations: Operating as a Pharmaceutical Distributor in the EU

In this article, we’ll be uncovering the crucial role of the distribution process, the essential guidelines that must be adhered to, and the various certifications and authorisations required for distributors operating within the EU. So, buckle up and let’s explore the exciting world of distribution together!

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Audits

Ensuring Quality With A Risk-Based Pharmaceutical Supplier Audit Plan

Regulatory bodies are requiring more thorough investigations into supplier audits for pharmaceutical companies in order to ensure the highest quality of sourced products and services. Risk-based supplier audit plans provide a systematic and cost-effective method for examining current and potential suppliers, and this article looks into the definition, benefits, and factors to consider when implementing this approach.

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General

Uncovering the Benefits of System Risk Assessment

System risk assessment (SRA) aims at identifying risks and vulnerabilities in the systems and processes that businesses use, and then determining what action needs to be taken to minimize the risks. This article will provide an overview of SRA, the different types of risk assessments, and the benefits of using SRA for businesses. 

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Manufacturing

5 Important Things to Consider Before Performing A Thermal Validation

To validate something is to prove its accuracy, and temperature validation is no different. When monitoring the temperature of an environment, the proof is just as important as a result. Read this article to learn more about thermal validations and key things you need to consider before performing one.

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This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

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