A C D E F G H I L P Q V
Pre Pro

Predicate Rules

Predicate Rules sind die eigentlichen Anforderungen der FDA – etwa 21 CFR 211 für Arzneimittel oder Part 820 (seit 2026 QMSR) für Medizinprodukte -, die festlegen, welche Aufzeichnungen zu führen und welche Unterschriften zu leisten sind. 21 CFR Part 11…
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Process

A process is a set of interrelated or interacting activities which transform inputs into outputs.…
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Process Validation

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes (EU GMP Annex 15). Initial validation establishes this capability; the…
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