Pharmaceutical Technology-11-02-2016

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

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

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.

Reliable, high-quality products require innovative analytics and production.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

Sartorius Stedim Biotech’s polyethersulfone membrane is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies.

Dual-Shaft Mixers from Ross, Charles & Son are suitable for mixing 50-, 100-, and 200-gallon batches.

Yarra 1.8µm SEC-X300 from Phenomenex is a high-resolution gel filtration chromatography (GFC)/aqueous size-exclusion chromatography (SEC) column for the separation of high molecular weight biomolecules on high-performance liquid chromatography and ultra-high pressure liquid chromatography systems.

The InvivO2 workstations range from Baker Ruskinn allow researchers to conduct cell culture processes under a continuously controlled, physiologically relevant atmosphere.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

The pharmaceutical industry has weathered its share of “black swan” events.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

In 2009, the International Pharmaceutical Excipients Council introduced an Excipient Information Package that includes a product requirement datasheet, site quality overview, and site and supply chain security overview.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

CMO executives are focusing on M&A activity, new business models, and fundraising limits.

FDA redefines cocrystals as APIs and not drug-product intermediates.

CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

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