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Preserving Quality and Compliance: Which Storage Guidelines Should Be on Your Radar?

A significant proportion of medicinal products, including vaccines and biologics, are temperature-sensitive, requiring stringent storage conditions. The cold chain is crucial in the pharmaceutical supply chain, ensuring careful management of temperature-sensitive products. Auditors play a vital role in scrutinizing cold chain management, ensuring adherence to regulatory standards. European regulations such as EU GMP and EU GDP guidelines, along with the WHO Model Guidance, provide comprehensive frameworks for manufacturing, storage, and distribution, safeguarding the quality and safety of pharmaceutical products. Compliance with these regulations is essential for protecting public health.

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Quality Risk Management Demystified: The Essential Steps (by ICH Q9)

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.

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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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