Recent regulatory and compendial updates
emphasize the importance of gaining
full knowledge about our manufacturing
processes. The more information and
knowledge we have about our processes
and products, the more control tools
might need to be introduced to achieve
the expected quality of our products. The
draft version of the EU Annex 1 revision
emphasizes the use of quality risk management (QRM) principles to prevent microbial
contamination
in the final
product.
In other words, the collection of records/data
from our processes is the way to gain more
knowledge about our processes.
Within this context, USP <1207> Sterile Product
Packaging—Integrity Evaluation supports
Annex 1 by describing and recommending the technologies to support container
closure inspection purposes.