Newsletter | January 7, 2014

01.07.14 -- The New USP Chapter 41: Are You Compliant?

Pharmaceutical Online Newsletter
Departments:
Manufacturing Packaging QA/QC
Logistics Critical Environments Inspection
» Guest Column
Should You Outsource Labeling And Artwork?
By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward
My previous article discussed the different aspects of technology required to support the labeling and artwork process. In this article I will look at the question of whether or not to outsource some or all of the activities involved in your labeling and artwork process.
UPCOMING TRAINING

cGMP Compliance: Top Trends To Know For 2014
Date: Wednesday, January 22, 2014 • Time: 1pm – 2:30pm EST

FDA GMP Inspections: Proven Preparation And Survival Techniques
Date: Thursday, January 30, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Manufacturing
The New USP Chapter 41: Are You Compliant?
By Jennifer Camarda, Sales Specialist, Premium Balances And Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective, and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed, from Weights and Balances to just Balances, and it does not reference the minimum sample weight anymore, but rather, it defines repeatability and accuracy, which specifies the operating range of a balance. The operating range is limited to the maximum capacity of the balance, and begins at the point at which the balance's repeatability is less than or equal to 0.10%. The weighing must also be performed using a balance that is calibrated over its operating range.
WHITE PAPER: Lower Project Risk And Cost With M+W Automation
By John Blanchard, M+W Group
M+W Automation recently briefed ARC Advisory Group on its role in M+W Americas as well as its business expansion activities and services capabilities.
DATASHEET: 100 Percent Mycoplasma Retention: STyLUX SC0.1 üm PES Filter
By Meissner Filtration Products, Inc.
BROCHURE: Cadence Single-Use Inline Concentrator
BROCHURE: Monitoring Technology For Medical Steam Sterilization
PRODUCT: Pharmaceutical Flexible Containment
» Packaging
WHITE PAPER: The Compulsion To Innovate In The Pharmaceutical Industry: A Snapshot Of The Situation
By Uwe Amann, Harro Hüfliger Packaging Systems
In the years 1996 to 2003, the number of NMEs approved by the FDA halved, while the research expenditure in the same period almost doubled. Only roughly one in 5,000 researched substances can be developed into a new drug.
BROCHURE: Nondestructive Package Inspection Technologies Overview
SERVICE: Contract Packaging Services For Clinical Trials
PRODUCT: Pharmaceutical Capsule Filling Machine: GKF Capsylon 705
PRODUCT: Vertical Reject Metal Detector System
» QA/QC
ARTICLE: A Process Analytical Technology (PAT) Approach To Automated Container Closure Integrity Testing (CCIT)
By Andrea Simonetti, Bonfiglioli Engineering SPA
This article provides the overview of the process analytical technology (PAT) methodology application to an automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.
APPLICATION NOTE: Syloid FP Silica Improves Flow Properties And Helps Prevent Caking
DATASHEET: Liquid Particle Counters: NanoCount 50+
By Lighthouse Worldwide Solutions
PRODUCT: GeoPyc 1360 Envelope Density Analyzer
PRODUCT: High-Throughput Rheometer: HTR
» Logistics
GUEST COLUMN: Why Life Sciences Companies Need An Agile And Reliable Supply Chain
By Jamie Hintlian, Ernst & Young
Limited supply chain agility increases the odds that your company will not be able to respond adequately and rapidly enough to changing market conditions or competitive moves. At best, a less reliable supply chain puts supply continuity at risk; at worst, it puts patient safety at hazard. Ernst & Young’s recent Growing Beyond survey reveals that there are clear differences in how leaders and laggards are mobilizing to address those issues.
ARTICLE: Marine Transportation Becomes Feasible For Pharmaceuticals
CASE STUDY: Supporting Global Medicinal Delivery At The Right Temperature
BROCHURE: Air Cargo Integrity
» Critical Environments
ARTICLE: Save Time And Money With Wash Cycles In Less Than One Hour
BROCHURE: CrimpLoc: Secure Closure Containment System
BROCHURE: VHP M100 Biodecontamination Closed-Loop System
PRODUCT: Nuclear Glovebox
PRODUCT: Compounding Pharmacy Equipment
» Inspection
APPLICATION NOTE: Continuous Monitoring Of Microbial Contamination With Instantaneous Results
WHITE PAPER: Why Filler Feedback Is Important For Checkweighers
DATASHEET: Ultra-Light Weight Checkweighers: CW3 400UL
By Loma Systems and Lock Inspection
DATASHEET: Oxygen Detection: OX-TRAN Model 2/21 10x Module
By MOCON, Inc.
PRODUCT: Plug And Play Portable Tablet Inspection System: PAPPIS
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