packaging line automation

ISPE Provides Guide On Design Of Packaging Facilities

The comprehensive guide emphasizes risk-based evaluation for complying with FDA cGMP regulations.
ISPE, the International Society for Pharmaceutical Engineering, has released new guidance on design, construction, commissioning, and qualification of packaging, labeling, and warehousing (PACLAW) facilities.
In presenting the first comprehensive guidance for PACLAW facilities for meeting FDA cGMP requirements, “ISPE Good Practice Guide: Packaging Labeling, and Warehousing Facilities” addresses Quality by Design, with directions on how to comply with FDA’s systems-based approach with a risk-based inspe
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