Quality Assurance/Quality Control
Design Quality in Pharmaceutical Design: A Primer for Facility Executives
March 07, 2025
Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.
FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides
January 03, 2025
The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.
Specification Equivalence—A Practical Approach
December 30, 2024
In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
The Impact of USP Chapter <86> on Endotoxin Testing
December 11, 2024
Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter Bacterial Endotoxins Test Using Recombinant Reagents.
Enhancing Quality Through Training
December 11, 2024
With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.
Pii Boosts Prefilled Syringe Capabilities with $3.6 Million Investment
November 23, 2024
The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
November 08, 2024
Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.
Data Governance, Data Integrity, and Data Quality: What’s the Connection?
November 06, 2024
Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected?
What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?
October 23, 2024
This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.
AAPS PharmSci 360: The Importance of HCP Analysis in Biomanufacturing
October 23, 2024
Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.