Quality Systems

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

Articles

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Application of QbD and QRM to Analytical Method Validation

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

Europe Strengthens Collaborations with Japanese Pharmacopoeia

The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.

OMCL Network Met Market Demand in Europe During 2015

Susanne Keitel, MD, is head of the European Directorate for the Quality of Medicines of the Council of Europe. EDQM is responsible for the European Pharmacopoeia.

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

Significant Revisions and Updates to the European Pharmacopoeia

The agency now allows production of water for injection by non-distillation technologies.

European Pharmacopoeia Revises WFI Monograph

The directorate is looking for experts to join the European Pharmacopoeia network.

EDQM Looking for Experts

Agnes Shanley is senior editor of Pharmaceutical Technology.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

Optimizing Semisolid Dosage Forms

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

EMD Millipore Presents New Sustained-Release Excipient for Oral Dosage Forms

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.