Understanding Container Closure Integrity Testing

Understanding container closure integrity systems, reviewing past observations, and following the regulations and guidance documents are excellent ways to establish a compliant container closure integrity assay. This article describes recent changes to the United States Pharmacopeia (USP) , guidance documents, regulatory observations, common container closure methods, and provides recommendations on developing and validating a compliant container closure integrity test.

09-30-14-Presentation-Stability-Testing-Seminar-FDA-News-Virtual-Conference-September-30-2014

09-30-14-Presentation-Stability-Testing-Seminar-FDA-News-Virtual-Conference-September-30-2014

Stability Testing of Pharmaceutical Products

ABSTRACT

Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review

Single-Use (SU) Container Closure Integrity (CCI)

Regulatory & Industry Requirements
SSB Position Statement on SU-CCI
Quality Risk Management, Process Validation and QC
Supplier bag chamber leak test and Integrity Testing
Pre Use Leak Testing for Flexboy®
Conclusions

CONTAINERS—PERFORMANCE TESTING

á671ñ CONTAINERS—PERFORMANCE TESTING