To ensure a successful GxP outsourcing program, it is essential to proactively identify potential issues and implement strategies to mitigate them before they escalate into significant problems. Here are four valuable tips for effectively managing risk during GxP outsourcing:
In our latest article, we provide a comprehensive overview of the outsourcing process in the pharmaceutical industry. Discover how to maximize communication and oversight of your contracted operations to deliver real value to your organization
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.
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.
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!
In this article, we will explore the impact of technology on life science manufacturing, from intelligent automation to electronic Quality Management Systems.
This article provides an overview of the European Union (EU) legislation and explains the licensing requirements for marketing pharmaceutical products in Europe.
The use of digital technology in the quality assurance and control process can help standardize and streamline processes, making it easier to find potential issues and implement corrections. Automated systems can be used to monitor products, processes and documentation, and to perform tests more quickly and accurately.
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.
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.
Download our free Ultimate FMEA Guide, which is dedicated to GMP and pharma professionals.
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.
