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The new Annex 1 revision emphasizes validation and qualification for sterile drug production as well as the importance of contamination control strategies, cleanroom classification, and personnel gowning. Ensure product quality and contamination control in your products by learning about in-depth requirements for premises and equipment.
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Implementing an effective Contamination Control Strategy (CCS) requires the collaboration and expertise of professionals across various departments. Discover how a robust CCS can mitigate contamination risks and gain insights from Ugo Omeronye's detailed responses in our comprehensive reference guide.
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Understanding and managing critical air patterns are essential for controlling an environment, particularly in the pharmaceutical industry, where adherence to regulations is paramount. Read more to understand their enhanced role in quality by design and revised Annex 1 guidelines.
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Watch to review how standards and regulations promote a cohesive environmental program that applies to the risks of specific manufacturing environments, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.
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Annex 1 mandates a risk assessment to identify optimal sample point locations and is crucial to understand the implications of these locations in terms of environmental control. Uncover factors in risk assessment, equipment selection, and system design to maximize data value.
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Modern environmental monitoring systems are vital for pharmaceutical manufacturing. Gain insight into how this advanced system offers a comprehensive suite of tools for data collection and the benefits of having a tool for analysis and processing that ensures compliance.
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In the realm of pharmaceutical manufacturing, maintaining cleanroom compliance is absolutely essential. Safeguard the cleanliness and safety in your pharmaceutical manufacturing with cleanroom standards cards that simplify compliance with concise and essential information from major regulatory bodies.
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