cGMP MANUFACTURING Clause Samples
The cGMP Manufacturing clause requires that all manufacturing activities comply with current Good Manufacturing Practices (cGMP) as defined by relevant regulatory authorities. This means that any products or materials produced under the agreement must be made in facilities that follow strict quality control, documentation, and process standards to ensure product safety and consistency. By mandating adherence to cGMP, the clause helps ensure that products meet regulatory requirements and reduces the risk of quality failures or regulatory non-compliance.
cGMP MANUFACTURING. When manufacturing material for use in human clinical trials, all product shall be manufactured according to cGMP guidelines. Any manufacturing deviations that could result in loss of drug product for use in clinical trials shall be reported to the Contracting Officer via a deviation summary report. Visterra, Inc. HHSO100201500018C
cGMP MANUFACTURING. 10.1.1 Objective: Manufacture, at ***** two lots of bulk Drug Substance according to cGMP.
cGMP MANUFACTURING. 16 11.0 QUALITY ASSURANCE AND QUALITY CONTROL.................................17