Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Companies can use metrics as a tool to help drive positive change and quality process improvements.
The contract provider needs to know as much as the NDA holder.
The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.
Contract organizations must have highly organized teams and plans to accommodate today's audits.
Why SOPs are rarely followed, often cited, and in great need of follow-through.