Packaging and Labeling

Shifts in Container Closure Integrity Test Methods
Technical
Shifts in Container Closure Integrity Test Methods
Newer container closure integrity (CCI) test methods are more accurate and reliable than longtime industry standards. Transitioning to include deterministic testing alongside probabilistic methods may seem daunting at first, but it is in the industry’s best interest.
Guidance Documents
Guidance Docs

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

Good Practice Guides
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.
Guidance Documents
Guidance Docs

Overview of Packaging Validation for Drug Products

Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding...
PE Magazine
PE Magazine

Processing and Package Equipment and Automation

Drug packaging is expected to be multi-purpose in today’s complex pharmaceutical supply chain with constantly increasing global challenges, including...
Development & Manufacture of Drug Substances, ICH Q11
Guidance Docs

GMP Regulation Handbook: Development & Manufacture of Drug Substances, ICH Q11

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics...