Quality Systems

Articles

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  

EMA Reviews Data on Paternal Exposure to Valproate

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

Kevin O’Donnell is R&D manager at DuPont Nutrition & Biosciences

Cliff Campbell is senior consultant at KPC.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles. 

Quality Quartets in  Risk-Based Qualification: ICH Q9(R1) Considerations

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

The industry is taking steps to automate the final product inspection process for complex therapeutics.

Progressing Finished Product Inspection Through Automation

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Ensuring OSD Quality and Safety

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

The more information shared, the smoother the approval process, says 
Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates. 

Sharing Critical Information for the Best Outcome

Kevin M. Kane, PhD, is CMC strategy director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Eugene J. McNally, PhD, is vice-president, early engagement and regulatory strategy, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Jeff L. Garwin, PhD, MD, is associate clinical science director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Debra A. Schaumberg is vice-president and global head, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Exploring an Intelligent Drug Development Paradigm

Environmental monitoring data can help keep sterile environments sterile.

Microbe Monitoring

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Drug Product Impurities Testing

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Quality Assurance/Quality Control