Newsletter | May 17, 2012

05.17.12 -- 7 Ways To Prepare For An Inspection

Pharmaceutical Online Newsletter

In This Issue:

From The Editor

7 Ways To Prepare For An Inspection
By Lori Clapper, Editor
In the pharmaceutical, biopharmaceutical, and medical device industries, regulatory compliance is a major responsibility and a common source of anxiety. However, there’s no need to stress over the possibility of an FDA inspection — if you take the appropriate steps to prepare. This was the guidance Rosario Quintero-Vives, regulatory and compliance specialist with RQV Consulting, offered to a packed room of INTERPHEX 2012 attendees, on the potential problem areas to address before the FDA comes to call. She went on to highlight seven actions you can take to help make the inevitable FDA inspection go more smoothly. Read more.

Featured Articles

Guide To Pharmaceutical Isolation Systems
By Denise McIntosh, President and CEO, Integrated Containment Systems
Isolation and containment technology provides a safe working environment for manufacturing operators in R&D, testing, and material handling of hazardous and potent materials, such as active pharmaceutical ingredients.


Continuous Quality Verification As A Control Strategy For Biocontainers
By Max Blomberg and Christian Julien, Meissner Filtration Products, Inc.
Some have suggested that integrity testing should be adopted as standard practice to mitigate potential process risks and promote a more proactive approach toward robust operations. Whatever the motivation may be, can "integrity" testing of single-use assemblies deliver on its premise and does it truly accomplish what it claims to accomplish?


Configuring And Calibrating Smart Instruments
By Heikki Laurila, Product Manager, Beamex Oy
So-called “smart” instruments are ever more popular in the process industry. The vast majority of delivered instruments today are smart instruments. These new smart instruments bring new challenges to the calibration and configuration processes.

Featured Downloads

Product Sheet: Tergajet Low-Foaming Powdered Detergent
Concentrated to save you money, Tergajet low-foaming powdered detergent is phosphate-free, biodegradable, and readily disposable.


Brochure: Visionspect Contract Visual Inspection
Viswill Visual Inspection Equipment is the heart of Visionspect's contract visual inspection system. In use for over thirty years in Japan and the United States, this equipment has proven to be more accurate than manual inspection and provides a lower cost.


Brochure: Liqui-Cel Membrane Contactors
Membrana offers four fiber types of polyolefin-based membrane contactors. Each fiber and module design has unique qualities making it suited to various applications.


Supply Chain Visibility In Healthcare: Beyond The Dashboard
Given the personal and professional impact of timely, cost efficient and most importantly effective treatments, today's global healthcare industry faces enormous challenges and opportunities.


Employee Engagement As A Competitive Differentiator
Employee engagement is much more than just the latest HR buzzword. Typically defined as an individual’s degree of positive or negative emotional attachment to the person’s organization, job, and colleagues, employee engagement is an important HR metric that has real bottom-line impact — perhaps now more than ever.

Industry News

FDA Approves New Bristol-Myers Squibb Biologics Manufacturing Facility
Adamas, FDA Discuss Safety And Efficacy For Alzheimer's Therapy
Mylan Launches Generic Lipitor® In Five European Countries
Coping With New FDA Mandates For Drug Sample Distribution
Patheon To Cut 91 Jobs, Transfer Production In Restructuring Plan
CROs Set To Experience Rapid Growth As Development Costs For New Drugs Continue To Rise
Eisai Expands Marketing And Supply Agreement With Arena For Anti-Obesity Agent Lorcaserin
Lilly Oncology To Highlight Final Results For Phase III Lung Cancer Study
Maxygen To Receive $30M Payment From Bayer
Vetter Boosts Quality And Logistic Processes
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Spotlight On Filtration

Case Study: UF/DF Systems
The product is supplied to the UF/DF vessel from a chromatography system and then concentrated. When the target volume in the vessel is reached, the media is exchanged with a buffer through diafiltration. A control valve on the retentate side of the filters maintains a desired trans-membrane pressure (TMP).

Series 7 Standard Filter Housings
An emphasis has been placed on the integrity of construction of the filter cartridges. However, the filter cartridge housing is just as important a part of any filtration system.

Palltronic® AquaWIT IV Filter Integrity Test System
With the water intrusion test (WIT) fast becoming the in situ integrity test of choice for hydrophobic filters, the Palltronic AquaWIT IV system is the latest in the line of Pall’s state-of-the-art products developed specifically to perform crucial filter-integrity testing — accurately, reproducibly, and reliably.

SEFAR® PHARMA-Grade
When you choose SEFAR PHARMA-Grade, you take the risk and legwork out of the validation process. Sefar responded to the stringent requirements of the pharmaceutical industry by creating the highest quality standards available.

LifeASSURE™ PDA Series Filter Capsule Validation Guide
This guide contains validation data and regulatory support information pertinent to the LifeASSURE PDA series 0.2 micron rated filter capsules.
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Industry Event

3M Purification Life Sciences And Process Technologies Road Show

3M Purification will be on tour, May 14 to 24, traveling through the midwestern part of the United States, displaying the latest technologies for depth filtration/clarification, sterile membrane filtration, and single-use storage. Learn more.

BioPharma Equipment Auctions

 

 

Featured Products And Services

PureFlo® Polyethylene Filter Capsules
PureFlo® Polyethylene Filter Capsules

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ZenPure Corporation

Fisher® 95H Pressure Reducing Regulator
Fisher® 95H Pressure Reducing Regulator

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Emerson Process Management

Pharmaceutical Labels
Pharmaceutical Labels

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ATL (Ad Tape & Label)

AseptiQuik® DC Connector
AseptiQuik® DC Connector

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Colder Products Company

Pharmaceutical Roller Compactor: PP 250
Pharmaceutical Roller Compactor: PP 250

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Alexanderwerk, Inc.

FT4 Powder Rheometer Aeration Module
FT4 Powder Rheometer Aeration Module

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Freeman Technology Ltd

Southwest Airlines Cargo® Service Levels
Southwest Airlines Cargo® Service Levels

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Southwest Airlines Cargo

Radiolabeling Support
Radiolabeling Support

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Analytical Bio-Chemistry Laboratories (ABC)

High Containment Services
High Containment Services

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Pfizer CentreSource

Process Area Barrier Curtains
Process Area Barrier Curtains

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ILC Dover

Thermo Scientific HyClone Serum-Free Media
Thermo Scientific HyClone Serum-Free Media

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Thermo Scientific HyClone

Containment For Blending Systems
Containment For Blending Systems

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Flow Sciences Inc.