Pharmaceutical Technology-11-02-2016

Ask the Expert
Pharmaceutical Technology

November 02, 2016

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

Pharmaceutical Technology

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.

Regulatory Watch
Pharmaceutical Technology

November 02, 2016

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

Pharmaceutical Technology

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

Pharmaceutical Technology

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

Pharmaceutical Technology

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

Pharmaceutical Technology
Product Spotlight

November 02, 2016

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

Pharmaceutical Technology
Product Spotlight

November 02, 2016

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.

Pharmaceutical Technology

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

Pharmaceutical Technology
Features

November 02, 2016

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

Pharmaceutical Technology

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

Supply Chain
Pharmaceutical Technology

November 02, 2016

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

Pharmaceutical Technology
Supply Chain

November 02, 2016

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

Supply Chain
Pharmaceutical Technology

November 02, 2016

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.

Pharmaceutical Technology
Cover Story

November 02, 2016

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

Cover Story
Pharmaceutical Technology

November 02, 2016

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

Outsourcing Outlook
Pharmaceutical Technology

November 02, 2016

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

Pharmaceutical Technology
API Synthesis & Manufacturing

November 02, 2016

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

From The Editor
Pharmaceutical Technology

November 02, 2016

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

Regulatory Watch
Pharmaceutical Technology

November 02, 2016

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

Issue PDF
Pharmaceutical Technology

November 02, 2016

Click the title above to open the Pharmaceutical Technology November 2016 issue in an interactive PDF format.