Quality Systems

Articles

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Enhancing Quality Through Training

Nicholas Saraceno is editor at Pharmaceutical Commerce.

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

Pii Boosts Prefilled Syringe Capabilities with $3.6 Million Investment

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected?

Data Governance, Data Integrity, and Data Quality: What’s the Connection?

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

Feliza Mirasol is the science editor for 

Videos

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.

AAPS PharmSci 360: The Importance of HCP Analysis in Biomanufacturing

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan. 

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

CPHI Milan 2024: Navigating CMC Challenges for GLP-1 and Oral Peptides

Contract organizations offer assistance when managing changes to material suppliers during a product’s lifecycle.

Navigating a Material Supplier Change

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Quality Assurance/Quality Control