BioScreen provides cGMP data packages at an additional cost of the test performed. Please indicate on the sample submission form that this is required.
Test methods, which are not proprietary, can be provided to the client. All test methods can be reviewed on site during an audit of BioScreen. If a proprietary method is requested by a Government agency, BioScreen will provide the method directly to the agency. Minimal cost will be charged to the client for preparing and shipping these documents. Please inquire for charges.
Yes, BioScreen is registered with the Drug Enforcement Agency (DEA) and can handle schedule I through IV drugs. Please request a DEA form 222 to be sent to you prior to submitting any samples.
Current Good Manufacturing Practice (cGMP) regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing compliance of drug products with established specifications, must meet proper standards for accuracy and reliability. In addition, microbiological test methods may require validation per pharmacopoeia (USP, EP, etc) requirements. Please inquire with our sales department regarding the cost of method validations.