Quality Systems

Mitigating the Risk from Excipient Variability

August 03, 2022

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

An Integrated Approach to the Data Lifecycle in BioPharma

August 02, 2022

Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs

August 02, 2022

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Ensuring API Quality—The EDQM Perspective

August 02, 2022

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

FDA Joins Effort to Curb Drug Patent Abuses

August 02, 2022

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Ensuring API Quality—A Pharmacopeia Perspective

August 02, 2022

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

New Guidance on the Use of Real-World Evidence

August 02, 2022

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

Regulatory Applications for Biologics

August 02, 2022

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

FDA Confirms Ongoing Reliance on Remote Inspection Methods

August 02, 2022

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

The Stick and Carrot of Quality Management

August 02, 2022

How can we fix the quality manufacturing issues that come with product shortages?