Newsletter | April 19, 2012

04.19.12 -- 4 Fundamentals That Can Influence An FDA Inspection

Pharmaceutical Online Newsletter
Sponsor

In This Issue:

 

Visionspect is the industry’s first contract visual inspection system, offering automated visual inspection with no capital outlay. Using proven equipment and technology, we guarantee inspection results to levels that are unachievable by manual inspection, while saving clients valuable operating costs. Learn more.

Featured Articles

4 Fundamentals That Can Influence An FDA Inspection
By Holly Scott, Senior Consultant, Biologics Consulting Group, and former CBER Consumer Safety Officer and FDA Field Investigator
The FDA inspectional conclusion can often be impacted by how firm officials are handling the inspection and, in some cases, can be the difference between receiving an FDA-483 or not. So, what are some of the non-GMP variables that can influence the inspection result and how should you approach the inspection to improve the outcome?


The Role Of Pharmaceutical Packaging Partners In Times Of Growth
By Paul Dupont, Ropack, Inc.
The expanding global pharmaceutical industry projects a 4 to 6 percent annual growth and forecasts that it will reach a value of $1 trillion by 2014. The figures are impressive, yet they place significant pressure on pharmas to bring to market innovative drugs and novel drug delivery systems in order to be part of the growth. Faced with that pressure, many pharmas are streamlining their supply chain to focus on their core competencies and bring products to market faster.


What’s Eating Big Pharma Innovators?
By Matt Gurin, U.S. Reward Practice Leader for Life Sciences, Hay Group
Congratulations! You’ve been promoted. You’re a global leader in the new R&D organization. This is exciting since you’ve been sweating the outcome of the long-impending transformation for over a year.

Featured Downloads

A Robust Cold Chain With A Proactive Quality Improvement Approach
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops, and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas. Together with their forwarder UTi, Talecris has been using the Envirotainer containers worldwide since 2001, and the value-added service Shipping Summary Report since 2004.


Partnerships In Cold Chain Delivery
Against a backdrop of increasing regulations, fuel costs, and delays clearing customs (especially in developing regions), life sciences companies are turning to their logistics service providers (LSPs) to smooth the way.


Fact Sheet: Sterile Injectable Contract Manufacturing
JHP Pharmaceuticals has both the right scale and right experience to meet a broad range of sterile injectable contract manufacturing needs.


ShockWatch: Cold Chain Breach Prevention
Refrigeration equipment is not always reliable, and temperature can vary within a shipping container, delivery vehicle, lab, or collection site.


Sefar Life Sciences Brochure
In today’s demanding economic environment, the pharmaceutical industry is under pressure to develop new and more sophisticated medicines. The result is a requirement to innovate and streamline manufacturing operations.

INTERPHEX Booth 2132

Industry News

Roche Says They Won't Extend $6.8B Offer For Illumina
Lilly's John Lechleiter Becomes PhRMA Board Chairman
GE Healthcare, Refine Technology To Support Continuous Processing In Biopharm
Shire Adds Phase 2 Product Candidate To Its Regenerative Medicine Business
The U.S. Contract Manufacturing Outsourcing Market Revives
Bayer Updates Labels For Oral Contraceptives
Weiler Engineering Introduces MODEL 628 All-Electric Machine
Pepperl+Fuchs Introduces New Aseptic Cleanroom Operator Workstations
Takeda To Acquire URL Pharma
Agilent Technologies Releases Flexible LC Purification Portfolio
View more headlines

 

ICSE USA is an international exhibition and conference that connects the pharmaceutical community with outsourcing solution providers, offering a forum for business development, networking, and education. This is a not-to-be-missed opportunity for companies providing or looking for outsourcing services and solutions, including, but not limited to, contract manufacturing, clinical trials, contract research, and analytical services. Register to attend.

Spotlight On Inspection

Avoid Product Overfill, Loss Of Profits, And Recalls With Product Inspection Systems
Control underfill and overfill, instantly analyze and measure moisture content, or detect contaminants in packaged, bulk, and piped food and in pharmaceuticals with Thermo Scientific product inspection products.

Datasheet: Lock Metal Detectors For Bottles And Liquids
Lock has installed hundreds of bottle-style detection systems. All Lock Bottle Line Metal Detection Systems are available with a variety of soft reject systems custom designed for any bottle size.

INTERPHEX Booth 2977

Case Study: Marking, Verifying, And Sorting Reliable Product Tracking
The XMV system from METTLER TOLEDO Hi-Speed is instrumental in tracking products and minimizing the risks of counterfeit drugs in the pharmaceutical industry.

INTERPHEX Booth 3133

Sartorius Vistus® Metal Detectors
Seamless quality control, secure production processes, and above all, protection for consumers by shipping flawless products — your processes must satisfy these requirements 100% every day.

INTERPHEX Booth 2805

Brochure: Bonfiglioli PKI Series Pharmaceutical Leak Testing Machine
This machine features precision control, high repeatability, very low noise levels, and easy cleaning.

INTERPHEX Booth 3077
Browse the download library

Industry Webinar

A Smarter Approach For Characterizing The Solution Properties Of Polyolefins
A Smarter Approach For Characterizing The Solution Properties Of Polyolefins
With a 'mammoth' global production reaching over 100 million tons per year, polyolefins (mainly PE and PP) are of considerable importance in the global materials market.

Be Social!

 

 

Featured Products And Services

TESCOM PH-3200 Series
TESCOM PH-3200 Series

Product Details
Download Datasheet
Request Information

Emerson Process Management
INTERPHEX Booth 3455

Biological Asset Logistics
Biological Asset Logistics

Product Details
Download Product Sheet
Request Information

Marken

Acsis ProducTrak Asset Management
Acsis ProducTrak Asset Management

Product Details
Download Brochure
Request Information

Acsis Inc.

Secure Transportation Solutions
Secure Transportation Solutions

Product Details
Download Product Sheet
Request Information

FedEx Custom Critical

VAC-U-MAX Capsule/Tablet Conveyor
VAC-U-MAX Capsule/Tablet Conveyor

Product Details
Request Information

VAC-U-MAX
INTERPHEX Booth 2276

Document Management And Regulatory Compliance Solutions
Document Management And Regulatory Compliance Solutions

Product Details
Download Brochure
Request Information

Sitrof Technologies

UltraSnap™ Filter Assembly
UltraSnap™ Filter Assembly

Product Details
Download Brochure
Request Information

Meissner Filtration Products, Inc.
INTERPHEX Booth 2817

Custom Designed Modular Enclosures
Custom Designed Modular Enclosures

Product Details
Download Catalog
Request Information

Flow Sciences Inc.
INTERPHEX Booth 1024

Aseptic Pharmaceutical Isolators
Aseptic Pharmaceutical Isolators

Product Details
Request Information

IMA S.p.A.
INTERPHEX Booth 2553

Tablet Deduster: PharmaFlex Deduster
Tablet Deduster: PharmaFlex Deduster

Product Details
Download Datasheet
Request Information

Stevens Industries
INTERPHEX 2977

VHP® MD Series Sterilization System
VHP® MD Series Sterilization System

Product Details
Download Brochure
Request Information

STERIS Corporation

Tempest: The Perfect Tank Washer
Tempest: The Perfect Tank Washer

Product Details
Download Product Sheet
Request Information

Chemdet, Inc.