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03.18.2010 -- Improving Pharmaceutical Manufacturing Regulatory Risk

March 18, 2010

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In This Issue:

Featured Articles

Improving Pharmaceutical Manufacturing Regulatory Risk
By ACSYS, Inc.
Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in a manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist.


Buyer's Guide To Cold Chain Shipping
By FedEx Custom Critical
Determining a list of critical factors for your cargo is key in evaluating the effectiveness of a transport service provider in meeting your needs. Guidance set forth in the Parenteral Drug Association's Technical Report 39 urges the following considerations when hiring a transport service provider to maintain cold chain shipping. Ask some questions you need to ask of your carrier.


Double-Digit Growth: The Next Step For Dr. Reddy's
By Dan Schell, Life Science Leader magazine
It's 6:30 p.m. in Hyderabad, India, and G.V. Prasad is not where I expected him to be. The vice chairman and CEO of the $1.2 B Dr. Reddy's Laboratories, the second-largest pharmaceutical company in India, is not in his office surrounded by lawyers and PR staffers poised to interject during our interview with their spin on a particular topic.


Application Of A Reagentless Direct Conductivity Online TOC Analyzer For Clean-In-Place Verification
By MORK Process, Inc.
This paper describes a method for automating CIP validation analysis of both conductivity and TOC. This is achieved by integrating a reagentless direct conductivity online TOC analyzer with a modern mobile Clean-In-Place module for real-time cleaning verification.


PQLI Definition Of Criticality
By Roger Nosal and Tom Schultz, ISPE
This paper describes progress made by the Criticality Task Team within the ISPE PQLI initiative. It aims to provide a concise, coherent, and universal approach for determining criticality for parameters, material attributes, conditions, and quality attributes.

Spotlight On Coating

Brochure: Supercell Tablet Coater From Niro, Inc.
INTERPHEX Booth 1629
This is a revolutionary tablet coater that accurately deposits controlled amounts of coating materials on tablets — even if they are extremely hygroscopic or friable.

Brochure: Supercell Tablet Coater From Niro, Inc.

Product Overview: COREALIS Formulation And Process Development
Characterization of the active ingredient using analytical techniques such as SEM, XRPD, DSC, TGA, NMR, HPLC, and LC-MS, as well as physical testing methodologies such as the determination of particle size, distribution, compressibility, flow, and stability — in order to provide practical insights and quickly optimize the formulation.

Product Overview: COREALIS Formulation And Process Development

Product Sheet: G2 Platinum Series Discharge Stations
The Platinum Series Discharge Station manufactured by G2 is the highest quality and design available for the pharmaceutical, nutraceutical, and food industries. The nonproduct areas are all T-304 stainless steel and the product contact areas are T-316L stainless steel.

Product Sheet: G2 Platinum Series Discharge Stations

Product Brochure: Oral Solids Manufacturing
Catalent provides its customers with the latest innovations in processing technology and finished dosage form manufacturing. Catalent scientists have been involved in the development and production of more modified-release products utilizing fluid bed technology than most other companies in the industry.

Product Brochure: Oral Solids Manufacturing

Datasheet: LDCS Pilot Multicapacity Laboratory Hi-Coater System
The LDCS Pilot is a portable, self-contained system designed for laboratory and pilot-scale pan coating processes. Unique abrasion resistant perforations minimize tablet attrition. Each coating pan is manufactured with the latest antimarking technology, consisting of a high mirror finish and antislide baffles.

Datasheet: LDCS Pilot Multicapacity Laboratory Hi-Coater System

Product Brochure: Rocket™ Evaporator
Developed largely as a consequence of users' demands for an evaporator that could quickly process larger volumes of solvent in parallel and without supervision, the Rocket Evaporator is designed to dry or concentrate as many as six flasks, each containing up to 450mL of solvent.

Product Brochure: Rocket&trade; Evaporator

Featured Downloads

Datasheet: Malvern ALISS
The Malvern ALISS is an at-line particle size analyzer for dry powder processes that has applications in a wide range of processing industries, including powder coatings, minerals and cement.

Product Sheet: Macromolecules/Polymeric APIs
Over 30-plus years experience in developing and manufacturing polymeric carbohydrates make our Fresenius Kabi Austria plant in Linz the partner of choice for your macromolecule projects.

Brochure: Compactors And Granulators — WP 150 Pharma
The WP 150 Pharma roller compactor made by Alexanderwerk is a compactor and granulator designed for use in the pharmaceutical industry.

Product Sheet: G2 Production Series Blender
G2MH is pleased to announce its Production Series Containerized Blenders. Several designs exist including dual pedestal, single pedestal, lab scale, pilot plant, and post hoist. Materials of construction can either be carbon steel painted or all stainless steel.
Browse the download library

Industry News

Teva Wins: $5B Bid For Ratiopharm Beats Pfizer
Alpharma To Pay $42.5M In Whistleblower Kickback Case
Astellas Responds To OSI Pharmaceuticals' Rejection
Mannatech Defends Ambrotose® Product Patents With Latest Legal Action
BioTek's Synergy™ H4 Hybrid Reader Is Transcreener® Approved
K-Tron Process Group Introduces A New Material Flow Aid For Its Pharmaceutical Loss-In-Weight Feeders
Accelerating Cell-Based ELISA Procedures
WHO Extends Prequalification Of Merck's ROTATEQ For Global Use
UltraCap® H.D. Capsule In 40-Inch Length Provides Large Volume Filtration
Abbott Acquires Facet Biotech
Porvair Offers Comprehensive Microplate Catalog
Biomanufacturing Courses Receive International Association For Continuing Education And Training (IACET) Certification
Actavis Receives Approval Of Alprazolam ODT In The U.S.
Human Genome Sciences Announces Results Of Randomized Phase 2 Trial Of Mapatumumab
Teva Provides Update On Generic Temodar®
View more headlines

Featured Multimedia

Podcast: A Bitter Pill To Swallow &mdash;  Formulation Approaches To The Taste Of Drug Compounds
Podcast: A Bitter Pill To Swallow — Formulation Approaches To The Taste Of Drug Compounds
Listen to Dr. Vincy Abraham, senior scientist and manager of Aptuit's Structural Characterization Group, discuss the importance of taste analytics in the drug development process.

Bulletin Board

FlexAct
FlexAct
Sartorius Stedim Biotech Presents The FlexAct BP For Buffer Preparation

FlexAct is a new system that enables you to custom-configure single-use solutions for entire biomanufacturing steps. The FlexAct system consists of the central operating module that offers the widest variety of configuration options so that you can take complete control of practically any steps in upstream and downstream processing.

Industry Event

INTERPHEX
April 20 to 22 | New York, NY

Training

Featured Courses From The Center For Professional Innovation And Education

Project Management For The Phase 3 And LCM (Life Cycle Management) Of The Drug Development Process
April 12 and 13 | Dublin, Ireland

How To Monitor Clinical Trials For GCP Compliance
April 12 and 13 | King of Prussia, PA

Best Practices For Facilities And Utilities Design, Qualification, And Monitoring: Applying The Life-Cycle Concept
April 12 and 13 | King of Prussia, PA

Effective Qualification And Monitoring Of Processing Equipment And Their Control Systems
April 14 and 15 | King of Prussia, PA

Detecting Fraud And Misconduct In Clinical Trials
April 14 and 15 | King of Prussia, PA

Pediatric Clinical Trial Design: Ethics, Management, And Regulatory Requirements
April 20 and 21 | King of Prussia, PA

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Model 6D(SG) Soft Gelatin Capsule Tester
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Nilfisk GM 811 Pharmaceutical Vacuum
Nilfisk GM 811 Pharmaceutical Vacuum

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