Written by LBG’s Lauren Schoukroun-Barnes, Ph.D., Dianne Cantara, Sarah DeDonder, Ph.D., and Dawn Speidel, “Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic” was recently published in BioProcess International.
The article reinforces the need for Quality oversight to ensure that Quality is built into the manufacturing, testing, and evaluation of a product.
“Companies do not have to be compliant with every single area when in the earlier stages of development,” says Dr. Schoukroun-Barnes. “By following the required ‘phase-appropriate’ aspects of the Code of Federal Regulations (CFR), companies can become more efficient while moving along the product development lifecycle. In addition, by integrating Quality within product development at an early stage, companies are more prepared when transitioning from nonclinical to clinical studies.”
Working together was a collaborative process that allowed each team member to contribute their expertise and insight.
“We hope the article explains the pharmaceutical quality requirements within a changing regulatory landscape,” says Dr. Schoukroun-Barnes. “Incorporating quality earlier into product development mitigates future burdens on early- to mid-stage pharmaceutical companies and enables ongoing compliance.”
Read the complete article here.
BioProcess International is a monthly, controlled-circulation magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics.