Ask the Expert: Enhancing Out-of-Specification Procedures

This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Link to the Video and Article on Pharmaceutical Technology

Strengthening Out-of-Specification (OOS) Investigations and Procedures

Despite established regulatory guidance, pharmaceutical companies continue to receive inspection observations related to out-of-specification (OOS) procedures. In this Ask the Expert discussion, Susan J. Schniepp of Nelson Labs and Siegfried Schmitt, PhD, of Parexel explore common challenges in OOS investigations and how organizations can strengthen their processes.

The experts emphasize the importance of avoiding overly restrictive procedures that delay investigations and adopting a more comprehensive approach to identifying root causes. Key recommendations include implementing robust trending to identify recurring issues, evaluating the entire process from sampling through laboratory testing, and assessing potential sources of human error.

The discussion also highlights the importance of consistent OOS procedures across contract partners, comprehensive employee training, and electronic systems that provide timely access to relevant data. By focusing on process transparency, effective investigations, and meaningful performance indicators, pharmaceutical manufacturers can strengthen their OOS programs and improve inspection readiness.

Read the full article and watch the Ask the Expert discussion:
Strengthening Out-of-Specification (OOS) Investigations and Procedures