Premises

Premises must facilitate proper operation. This applies, in particular, to proper manufacture, control, storage, packaging and marketing of medicinal products. The individual requirements depend on the type and scope of production.

With our pdf downloads we offer clear and concise guides about this specific GMP topic.

Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets

What safety features for product and personnel protection do isolators provide? What regulatory requirements must be met?

With this clear and concise guide you will get answered to these and other frequently asked questions!

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Classes and Grades for Air Cleanliness

This pdf download provides you with the tools you need to achieve compliance with the limits for airborne particles and microorganisms. Learn all you need to know about GMP requirements for cleanroom premises!

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The Ultimate Checklist for Premises and HVAC Qualification

Do you know which regulatory and normative provisions are to be observed? Are you using checklists for the systematic handling of qualification activities?
Here is what you need: a pdf download providing you with all you need to know about the qualification of premises.

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Monitoring of HVAC Systems in GMP Environments

This pdf download explains all important aspects regarding pharma monitoring of HVAC systems, including physical and microbiological monitoring, as well as validation of the monitoring system in accordance with GAMP®5.

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Environmental and Microbiological Monitoring at Drug Manufacturing Sites

This pdf download leads you step by step through the 4 key processes in microbiological monitoring.
Additionally you will get a detailed look at monitoring and testing in 3 critical areas: surfaces, personnel and air.

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