Newsletter | March 25, 2014

03.25.14 -- Key Points Of FDA's Draft Guidance On Manufacturing Quality Agreements

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QA/QC Inspection Critical Environments
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» From The Editor
Key Points Of FDA's Draft Guidance On Manufacturing Quality Agreements
By  Laurie Meehan, Polaris Compliance Consultants, Inc.
Last year, the FDA published its draft guidance, officially titled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." Here are some of the highlights.
Featured Focus: QA/QC
An Optical Particle Counter Calibration Standard And What It Means To Cleanroom Owners
By Tony Harrison and Bob Latimer, Hach Ultra Analytics
ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the life sciences industry, with the increasing trend for real-time air particle monitoring in cleanrooms using light-scattering air particle counters.
APPLICATION NOTE: The Importance Of A Good, Nonviable Measurement: Real-Time Viable Particle Counter
CASE STUDY: Analyzing Big Data Sets From Small Molecules
DATASHEET: Liquid Particle Counters: NanoCount 25+
By Lighthouse Worldwide Solutions
POSTER: Development And Qualification Of A Test Chamber And Laboratory For RMM Validation
» Inspection
WHITE PAPER: Advanced Leak Test Methods
By Hemi Sagi, Director, ATC, Inc.
Before new technologies were available to directly measure very small leaks, most leak measurements were done indirectly. Direct mass leak flow measurement has many advantages.  It is independent of part volume or configuration, and it's not sensitive to temperature changes.
PRODUCT: Optimizing Quality And Driving Costs Down With Vision Inspection Systems
PRODUCT: Lid Deflection Leak Testing For Pharmaceuticals
PRODUCT: X-Ray Inspection For Bulk Flow Products
PRODUCT: Pharmaceutical Tablet And Tooling Microscope Inspection
» Critical Environments
Q&A: 5 Glassware Washing Concerns For Drug Development Labs
A Q&A with James Espiritu, Laboratory Equipment Business Applications Manager, Miele
As in any analytical lab, cross-contamination due to improper glassware washing is one of the major sources of experimental error in a drug development lab. The good news is that cross-contamination is totally preventable, and it is possible to have excellent control over the glassware washing operation using a properly validated, sophisticated labwasher.
APPLICATION NOTE: Cleaning Of Cosmetic Creams And Lotions From Laboratory Glassware
DATASHEET: Hydrogen Peroxide Vapor (HPV) Biodecontamination Walk-In Chamber
By Bioquell Inc.
BROCHURE: Automatic Process Polarimeter: Propol
BROCHURE: Glacier: Ultralow Laboratory Freezer
» Logistics
APPLICATION NOTE: How To Avoid FDA 483s For Temperature, Humidity, And Other Controlled Environments
WHITE PAPER: What's The Impact Of Big Data In The Cold Chain?
CASE STUDY: When It Comes To Shipping Perishables, It's The Little Things That Make A Big Difference
SURVEY: Assessing The Future Of The Cold-Chain Industry
VIDEO: AcuTemp Passive Shippers Video
» Manufacturing
APPLICATION NOTE: Allegro 2D Powder Port Biocontainer: Recirculation Mixing At 20 L And 50 L
DATASHEET: DFS Flow Meter Filler
By Filamatic
BROCHURE: Continuous Manufacturing: Moving Toward Real-Time Release
BROCHURE: Tissue Sterilization Processing Services
BROCHURE: Single-Use Depth Filtration: Zeta Plus
PRODUCT: Pharmaceutical Powder Handling Transfer Systems
PRODUCT: Saltus M200 Single-Use Mixing System
» Packaging
BROCHURE: Package Integrity Inspection System: Veripac Series
SERVICE: Solid Oral Dosage Contract Packaging
PRODUCT: Capsule Filling For GMP Requirements
PRODUCT: Sorbent Dispensing Equipment

Quality Agreements And FDA: What You Must Know To Comply
Date: Wednesday, April 2, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
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