Analytical Testing Services to Support Repackaged Product Safety and Compliance
Pharmaceutical repackagers face distinct regulatory and quality control challenges. Whether relabeling for distribution, changing packaging formats, or consolidating lots, each step requires documented evidence that drug identity, strength, and integrity remain intact. Testing programs must account for the effects of repackaging on product quality, packaging compatibility, and shelf life—while aligning with FDA, USP, and ICH requirements.
BA Sciences delivers analytical testing services tailored to the needs of pharmaceutical repackagers, supporting compliance with current Good Manufacturing Practices (cGMP) and helping ensure safe, effective product distribution.
Our Testing Capabilities for Repackaged Products
We offer a range of analytical and microbiological testing services to support repackaging operations:
- Identity and strength verification
To confirm that the drug substance remains consistent post-repackaging using validated methods such as HPLC and spectroscopy. - Container-closure integrity testing (CCIT)
To ensure packaging maintains sterility and prevents contamination under expected storage and transport conditions. - Stability and shelf-life evaluation
To assess whether repackaging impacts product degradation under ICH-specified conditions. - Particulate and appearance testing
To detect visible and subvisible particulates and confirm that product presentation remains acceptable. - Microbial testing
To perform USP <71> sterility, USP <85> endotoxins, bioburden, and USP <61>/<62> microbial limits testing, as applicable.
Each study is documented in accordance with applicable regulatory requirements and aligned with USP, EP, or JP standards.
