Investigating Patient Complaints About Combination Products

In this audio clip originally published by by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Link to the audio clip and article on Pharmaceutical Technology

Investigating Prefilled Syringe Complaints and Component Failures

When a patient reports that a prefilled syringe failed to inject, determining the root cause can be challenging, particularly when the drug manufacturer purchases the syringe from an external supplier. However, pharmaceutical manufacturers remain responsible for the quality and performance of their finished products, including the components used in their delivery systems.

In this Ask the Expert discussion, the expert explores how manufacturers can approach complaints involving commercial syringe components, emphasizing the importance of supplier qualification, quality assessments, and thorough complaint investigations.

The discussion also highlights the role of human factors and usability testing in ensuring that delivery systems are suitable for their intended patient populations. Manufacturers should evaluate whether patients can use the device correctly and whether existing instructions adequately address potential challenges.

Additionally, the article emphasizes the importance of reviewing complaint procedures, evaluating real-world feedback, and establishing clear responsibilities through supplier agreements and quality agreements. By strengthening supplier oversight, usability assessments, and complaint management processes, manufacturers can better address device-related complaints and support product quality and patient safety.

Read the full article and watch the Ask the Expert discussion:
Investigating Prefilled Syringe Complaints and Component Failures