Our latest article delves into the nuances of FDA’s Form 483, offering essential guidance on how to transform FDA observations into concrete actions.
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In an industry that is constantly evolving, it’s crucial to stay informed about the latest trends and updates. In this article, we shall journey into the heart of Good Manufacturing Practice (GMP) — reviewing the key changes and developments over recent years.
In this blogpost, we delve into the common challenges faced during audits and provide effective solutions to help you navigate through them. By implementing these strategies, you can transform the daunting prospect of audits into an opportunity for achieving audit success.
In this article, we’ll explore how the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has shaped the landscape of regulatory compliance and fostered a more flexible approach to ensure the registration of safe, effective, and high-quality medicines worldwide.
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:
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.
Remote audits in the GMP world, have become a necessity because of the COVID-19 pandemic. Qualifyze posses a lot of experience with remote audits and shares their helpful insights through this case study.
In this article I will give you five reasons and explain to you how external auditors can save your organization a lot of trouble and money.