Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Ensuring OSD Quality and Safety

August 02, 2023

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Phasing Out COVID-19 Regulatory Flexibilities

August 02, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Industry Challenges Medicare Price Negotiation Scheme

August 02, 2023

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Sharing Critical Information for the Best Outcome

August 02, 2023

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

Exploring an Intelligent Drug Development Paradigm

August 02, 2023

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Microbe Monitoring

August 02, 2023

Environmental monitoring data can help keep sterile environments sterile.

FDA Releases Guidance on Standards Related to Pharmaceutical Quality

August 01, 2023

The program aims to aid submissions from external stakeholders and FDA staff.

FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals

August 01, 2023

The guidance document outlines recommendations to limit potential carcinogenic risk.

Drug Solutions Podcast: Innovations and Advances in Drug Dosage Forms

August 01, 2023

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

Congress Leaves Town with Major Drug-Related Bills on Hold

July 28, 2023

Pandemic, PBM, and other policies on hold during the summer recess.