Quality Systems

Articles

Validation and batch testing failures were among the violations found by the FDA at the company’s 
Jiangsu facility.


Wuxi Medical Instrument Factory Receives FDA Warning Letter

The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.

FDA to Fund Manufacturing Research Programs at NIPTE

Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.

Scripps Confirms QC Mechanism that Protects Protein Production

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Process Validation: Do We Need Brainwashing?

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

The Role of the Quality Unit

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Hildegard Bruemmer, PhD, is operational laboratory manager at SGS Life Sciences, Germany. 

Forced degradation studies can identify stability problems for drug substance and drug products.

Stepping Up the Pace of Drug Stability Studies

Frances DeGrazio is Vice President, Marketing and Strategic Business Development at West Pharmaceutical Services, Inc.

When it comes to getting the best out of quality by design, timing is everything.

A QbD-Based Approach to Drug Packaging and Delivery

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

A Look at Batch Record Review

James Jardine is a marketing content specialist for MasterControl.

Walt Murray, ICLA, CSSMBB, president and CEO of ARC Experts and strategic partner for MasterControl Quality & Compliance Consulting, is a globally recognized compliance and risk consultant.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations. 

Quality Assurance/Quality Control