The document structure provides clear steps to move from package conception to a validated commercial testing program:
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Annex 1 requires manufacturers to implement robust CCI validation during design, routine manufacturing, and stability testing. Understanding the foundational principles laid out in TR 27 helps manufacturers understand the evolution of these stringent rules and design better holistic control strategies. Accessing the PDF
When a customer reports an empty syringe or a leaking vial, TR 27 provides a decision tree for root cause analysis:
Selecting the right materials (glass, plastics, elastomers) and designing the closure system.
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