BioConvergence LLC cGMP Stability Testing Program - Amazon Web ...
BioConvergence LLC cGMP Stability Testing Program Stability testing plays a crucial role in the drug development process.1 Stability studies support formulation development, the use of pre-clinical & clinical products, drug registration, and marketed products. Scientists at BioConvergence develop and conduct stability program planning, storage, and cGMP analytical testing of new chemical entities (NCE), active pharmaceutical ingredients (API), or drug-coated medical devices. Studies comply with cGMP requirements for 21 CFR Part 211 testing. ICH storage conditions of stability studies are listed below along with the minimum submission time requirements; however, in many instances these are increased over a longer period of time (e.g. 24 months – 48 months). ICH Storage Conditions for Stability Studies Intended Label Storage Condition Room Temperature Refrigerator Freezer
Stability Study Type Long Term Intermediate Accelerated Long Term Accelerated Long Term
Storage Conditions 25°C/60%RH 30°C/65%RH 40°C/75%RH 5°C/Ambient 25°C/60%RH -20°C/Ambient
Submission Minimum Requirements 12 months 6 months 6 months 12 months 6 months 12 months
Stability Test Program Materials: APIs, NCEs Combination products, formulated products, clinical trial materials Small & large molecule drugs Drug-coated medical devices Placeboes & controlled drugs Stability Test Program Services: Design and management of stability studies; offering custom time-points and reports Transportation, temperature cycling, and freeze/thaw studies Material compatibility testing (e.g. containers, packaging, stoppers, infusion sets, IV bags) Development and validation of stability indicating methods 1 – Huynh-Ba, Kim, Handbook of Stability Testing in Pharmaceutical Development, New York: Springer, 2009. Print.
BioConvergence LLC is audited to, and compliant with cGMP and ISO requirements as a service provider to the pharmaceutical, animal health, and medical device industries. Founded in 2006, the company is a woman-owned business operating in a 72,000 square foot facility in Bloomington, Indiana, within 90 minutes of both FedEx and UPS hubs. The company’s service lines include supply chain operations, drug formulation development, analytical methods development and testing activities, and labeling and kitting operations. •
Contact us to discuss requirements: 812.961.1700
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Website: www.bioc.us
BioConvergence LLC 4320 West Zenith Drive, Bloomington, IN 47404 BSLO-SO1215
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Stability Study Type Long Term Intermediate Accelerated Long Term Accelerated Long Term
Storage Conditions 25°C/60%RH 30°C/65%RH 40°C/75%RH 5°C/Ambient 25°C/60%RH -20°C/Ambient
Submission Minimum Requirements 12 months 6 months 6 months 12 months 6 months 12 months
Stability Test Program Materials: APIs, NCEs Combination products, formulated products, clinical trial materials Small & large molecule drugs Drug-coated medical devices Placeboes & controlled drugs Stability Test Program Services: Design and management of stability studies; offering custom time-points and reports Transportation, temperature cycling, and freeze/thaw studies Material compatibility testing (e.g. containers, packaging, stoppers, infusion sets, IV bags) Development and validation of stability indicating methods 1 – Huynh-Ba, Kim, Handbook of Stability Testing in Pharmaceutical Development, New York: Springer, 2009. Print.
BioConvergence LLC is audited to, and compliant with cGMP and ISO requirements as a service provider to the pharmaceutical, animal health, and medical device industries. Founded in 2006, the company is a woman-owned business operating in a 72,000 square foot facility in Bloomington, Indiana, within 90 minutes of both FedEx and UPS hubs. The company’s service lines include supply chain operations, drug formulation development, analytical methods development and testing activities, and labeling and kitting operations. •
Contact us to discuss requirements: 812.961.1700
•
Website: www.bioc.us
BioConvergence LLC 4320 West Zenith Drive, Bloomington, IN 47404 BSLO-SO1215
•
