Quality Assurance/Quality Control

In Equal Measures: The Importance of Excipient Quality

September 03, 2023

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

September 03, 2023

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Preserving Process Integrity: The Importance of Equipment Cleaning

September 03, 2023

A structured cleaning procedure is essential to ensure the effective cleaning of equipment.

Clearing Up Confusion in Inspection Terminology

September 02, 2023

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

EMA Reviews Data on Paternal Exposure to Valproate

August 18, 2023

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

August 11, 2023

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations

August 03, 2023

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

Progressing Finished Product Inspection Through Automation

August 02, 2023

The industry is taking steps to automate the final product inspection process for complex therapeutics.

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.

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.