Current Good Manufacturing Practice (cGMP) testing is required for manufactured products in order to meet the compliance standards of the international regulatory authorities. Charles River Biopharmaceutical Services (BPS) offers a comprehensive range of tests for medicinal drugs and medical devices. Our global testing capabilities and extensive in-house experience enable us to design testing packages that specifically suit your needs, while following the relevant guidelines.
Medicinal Drug (Oral Solutions/Injectables/Nasal)
- Finished product (cGMP)
- Endotoxin testing
- Excipient testing
- General safety testing
- Identity testing
- Preservative effiicacy
- Physico-chemical characterization
- Potency
- Purity/impurity profiling
- Pyrogenicity
- Stability
- Sterility
- Toxicology
Medical Devices
- Raw Materials
- (Bioburden, cytotoxicity, in vitro endotoxin testing, microbial analysis of water, microbial limits, sterility)
- Process validation
- Finished Product
- (Bioburden, in vitro endotoxin testing, microbial limits, sterility)
- Process validation
- Drug delivery
- Injectables, drug-coated devices
- Endotoxin, pyrogenicity, sterility
To check which of our BPS facilities perform these services and get local facility contact information, click here. For additional information, please contact us at askcharlesriver@crl.com.