Quality Assurance/Quality Control

Control Strategy: A Feedback-Feedforward ‘Controls Hub’ for Risk, Knowledge, and Product Lifecycle Management

September 29, 2023

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

Being Innovative in CGMP Training While Adapting to Change

September 19, 2023

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

Dealing with Data: How to Keep It Manageable

September 06, 2023

Advanced analytical tools generate more data in today’s labs than ever before.

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.