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Quality

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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GMP Trivia

Deciphering Temperature Directives: The Guidelines Governing Pharma Storage

The pharmaceutical industry relies on precise temperature storage to maintain product effectiveness and safety. Regulatory guidelines provide general principles, while organizations like the ICH and USP define specific temperature ranges. Adhering to these guidelines is crucial for minimizing risks and ensuring product integrity. Strict temperature storage protocols are essential for delivering safe and effective medications to patients.

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General

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

In this blog, we will delve deeper into the European regulations and guidelines that meticulously dictate the temperature storage requirements in the pharmaceutical domain. From understanding the basic principles to analyzing the nuanced details, we will provide you with a comprehensive guide to remain compliant throughout the entire lifecycle of temperature-sensitive products.

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Audits

Empowering Your Quality Journey: Essential GMP News from 2022-2023

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.

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