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The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Seven Success Criteria for Hiring (and working with) a Good GMP Consultant

Seven Success Criteria for Hiring (and working with) a Good GMP Consultant

Apr 16 | The QA Pharm

The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with a good GMP consultant.

Epiphanies – Disclose at Your Discretion

Epiphanies – Disclose at Your Discretion

Apr 6

I’ve recently come to the conclusion that there are two kinds of epiphanies – the kind you like to brag about and the kind where you look around and say to yourself, “Am I the last person to figure this out?”

Featured Articles

Outsourcing Clinical Research: Established vs. Emerging Markets

Outsourcing Clinical Research: Established vs. Emerging Markets

May 21

In recent years, emerging markets have been touted as an affordable and attractive labor pool for the outsourcing of pharmaceutical and biotechnology projects.

Getting the Best Results from Type I Ultrapure Water

Getting the Best Results from Type I Ultrapure Water

May 21

Type 1 ultrapure water is by far the purest substance used in a laboratory. This article discusses the high level of purity of type I ultrapure water, the importance of such purity and how to maintain this standard during normal laboratory use

How To Read A Regulator Flow Curve

How To Read A Regulator Flow Curve

May 16

When selecting a regulator, you are not just looking for the right size. You’re looking for a set of capabilities, which is a function of the regulator’s design. A flow curve illustrates the regulator’s range of capabilities at one glance. Once you understand a flow curve – and we’ll explain how – it is easy and very quick to read.  

A Novel Intradermal Adapter to Address the Growing Use and Demand of Safe, Reliable, and Repeatable Intradermal Delivery of Vaccines

A Novel Intradermal Adapter to Address the Growing Use and Demand of Safe, Reliable, and Repeatable Intradermal Delivery of Vaccines

May 16

Over the past few years, there has been a growing awareness of the unique benefits of delivering vaccines intradermally. Potential benefits include improved vaccine safety, increased vaccine effectiveness, and enhanced immunogenicity in hard to vaccinate populations such as the elderly.

Manufacturing Technologies

Stainless Steel Reactor System For High Temperature/Pressure Applications

Stainless Steel Reactor System For High Temperature/Pressure Applications

Chemical-Resistant Port Connectors

Chemical-Resistant Port Connectors

Stand Aids Single-Use Fluid Transfers

Stand Aids Single-Use Fluid Transfers

Flexible Isolators for Research and Development

Flexible Isolators for Research and Development

Sartorius Stedim Biotech and G-Con Manufacturing Announce Global Collaboration

Sartorius Stedim Biotech and G-Con Manufacturing Announce Global Collaboration

Single-Use Bags

Single-Use Bags

API and Drug-Development Contract Services

API and Drug-Development Contract Services

Biocontainers for Cylindrical Drums

Biocontainers for Cylindrical Drums

Containers Available in a Variety of Sizes

Containers Available in a Variety of Sizes

Continuous Quality Verification as a Control Strategy for Biocontainers

Continuous Quality Verification as a Control Strategy for Biocontainers

Single-Use Mixing Platform

Single-Use Mixing Platform

The Biosimilars Challenge

The Biosimilars Challenge

CMO Selected for Malaria Medicine

CMO Selected for Malaria Medicine

Biocontainers Accommodate R&D

Biocontainers Accommodate R&D

Gamma-Stable Stir Bars

Gamma-Stable Stir Bars

Parallel Bioprocess Development Tool

Parallel Bioprocess Development Tool

Single-Use Stirred Tank Bioreactor

Single-Use Stirred Tank Bioreactor

Filters for Pre-Filtration of Biological Fluids

Filters for Pre-Filtration of Biological Fluids

Singled Out

Singled Out

Bag Ports that Meet Biopharm Requirements

Bag Ports that Meet Biopharm Requirements

Single-Use and Disposable Systems and Devices in the Biopharm Industry

Single-Use and Disposable Systems and Devices in the Biopharm Industry

Ultra-Low-Temperature Freezers

Ultra-Low-Temperature Freezers

Single-Use Filling Control System

Single-Use Filling Control System

Single-Use TFF System

Single-Use TFF System

Mini Bioreactor System

Mini Bioreactor System

CMOs on the Hunt for Disposable Solutions

CMOs on the Hunt for Disposable Solutions

Ductless Chemical Workstations

Ductless Chemical Workstations

Single-Use Bioreactor Systems

Single-Use Bioreactor Systems

Single-Use Bioreactor Systems

Single-Use Bioreactor Systems

Vapor-Compression Distillation Unit

Vapor-Compression Distillation Unit

Ozone Generator for Biopharmaceutical Applications

Ozone Generator for Biopharmaceutical Applications


Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

White Papers

Ten Tips for Single Use Pharmaceutical Tubing Selection

By: New Age Industries / AdvantaPure | April 6, 2012

Tubing used in pharmaceutical and biotech applications has particular requirements. Among them are the ability to withstand sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal-derived ingredients. These industries also have tubing needs involving flexibility, performance, and cost that are common to many applications.This white paper offers ten suggestions on what to look for and investigate when it comes to narrowing down your single use tubing selection.

A GMP Warehouse Mapping Guide

By: Vaisala | April 6, 2012

GMP regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices and require “mapping” the temperature and relative humidity profile of warehouses for environmentally sensitive life science products. This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.

Perfect Fit for Lyophilized Moisture Analysis

By: Arizona Instruments | April 4, 2012

Testing for moisture in lyophilized materials has well documented benefits to ensuring quality and shelf life. It has been previously demonstrated that the Computrac® Vapor Pro® Rx is a perfect fit for testing for moisture in lyophilized samples. The samples can be tested in the lyophilization vials without ever being exposed to ambient air. The relative humidity sensor in the instrument is sensitive enough to allow for sample sizes as small as 5 mg.