Sanofi-Genzyme Together On CMO Reputation Management
Not long after Sanofi tied the knot with Genzyme in 2011, Piet Houwen was asked to lead contract-manufacturing operations. Now about 5 years into the marriage, I visit with Houwen to learn about this combination of Big Pharma and Big Bio, his role, and an attitudinal adjustment for better biologics outsourcing. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 7, 2016 Category: Pharmaceuticals Source Type: news

Taking Serialization to the Next Step
Keeping up with regulatory requirements has kept the pharmaceutical industry at the forefront of track-and-trace technologies for years. Now, those regulations are set to get even more stringent on a global scale. With some key deadlines on the horizon, pharmaceutical manufacturers and their OEM suppliers are stepping up their serialization strategies. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 6, 2016 Category: Pharmaceuticals Source Type: news

Serialization Officially Stated As A Mandatory Requirement Through The Release Of The Delegated Acts
Today the European Commission published the "Delegated Acts" on safety features in the Official Journal of the European Union, supplementing Directive 2001/83/EC (Falsified Medicines Directive). This publication effectively marks the start of a three year implementation period for all EU member states. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 6, 2016 Category: Pharmaceuticals Source Type: news

Serialization Of Powdered Milk For Babies
The hot topic of serialization is a concern not just for the representatives of the pharmaceutical industry. As a result of a loss of sensitive consumer confidence in domestic baby formula, China is increasing its imports of baby milk powder. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 6, 2016 Category: Pharmaceuticals Source Type: news

04.07.16 -- In Outsourcing, Genzyme Sees An Advantage
04/07/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 6, 2016 Category: Pharmaceuticals Source Type: news

New Guidelines Offer Menu Of Standard Sterile Packaging Tests
By John Kalkowski, contributing writer High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated.  Packaging integrity can literally be a matter of life or death to an ailing individual. It can have a significant impact on the well-being of a manufacturer as well. This is a major reason that many pharma and medical device companies are intensifying their package testing and enhancing their test methods.  ...
Source: Pharmaceutical Online News - April 5, 2016 Category: Pharmaceuticals Source Type: news

Marken Team Members And Network Of Specialists Trained To Handle A Variety Of Specialized Shipments, Including Dangerous Goods
Marken team members and our network of specialists are specifically trained to handle a variety of specialized shipments, including dangerous goods. While the largest outbreak is still centralized in Latin America, effects of the virus have already expanded into the US, Europe, and Asia Pacific. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 5, 2016 Category: Pharmaceuticals Source Type: news

How To Measure Oxidation Stability Up To 20 Times Faster, With Greater Precision And Efficiency
By Ross Roberts The problems and challenges of oxidation in foods, flavors, fragrances, and cosmetics Oxidation’s corrosive effects are everywhere, if you know where to look. Rust is an obvious example. Premature aging in people is a less obvious one. But one of oxidation’s most subtle yet profound effects is the corrosion it can have on the profits of companies producing foods, flavors, fragrances, and cosmetics. That’s because when their products containing natural fats or other lipids come in contact with atmospheric oxygen, the oxidation process begins, degrading the quality and shelf-life of these...
Source: Pharmaceutical Online News - April 4, 2016 Category: Pharmaceuticals Source Type: news

04.05.16 -- Reaction To FDA Safety Warnings -- What Pharma Manufacturers Need To Know
04/05/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 4, 2016 Category: Pharmaceuticals Source Type: news

The New Leadership Marketing
Marketing today centers on the demonstration of active leadership and its promotion.Executive Editor Louis Garguilo describes this as“leadership marketing,” and says it's a step beyond what has become a stagnant “thought leadership.” He also puts value in a name, and thinkslarge conferences don’t fit this new age. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - March 31, 2016 Category: Pharmaceuticals Source Type: news

Quality Metrics: How to Add Value and Meet the FDA's Expectations
Cheryl Abernathy, Quality Assurance Operations Manager, Ropack Pharma Solutions In the pharmaceutical industry, “Quality Metrics” can be defined as the measures used to assess the quality of drug manufacturing.  Metrics are one way that an organization can provide assurance to customers, stakeholders, and regulatory authorities that their regulated products are not only safe and effective, but that they are also manufactured utilizing high-quality standards. Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvemen...
Source: Pharmaceutical Online News - March 31, 2016 Category: Pharmaceuticals Source Type: news

Introducing New Non-Destructive Technology For Blister Package Testing At Interphex
PTI Inspection Systems will introduce a new technology platform to test blister packaging at Interphex, April 26-28, at the Jacob Javits Convention Center in New York City, Booth 3717. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - March 30, 2016 Category: Pharmaceuticals Source Type: news

03.31.16 -- The Impact Of Reformulation Strategies On Pharmaceuticals, Biologics
03/31/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - March 30, 2016 Category: Pharmaceuticals Source Type: news

3 Steps To Prepare For FDA's Final Quality Metrics Guidance
Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals. It prescribes a sequence for life sciences companies and contractors to improve and demonstrate process quality control and understanding. To help readers prepare for this new regulatory focus, this article will: Highlight the four key quality metrics recommended in the draft guidance Describe how companies can implement manufacturing quality metrics (MQM) i...
Source: Pharmaceutical Online News - March 29, 2016 Category: Pharmaceuticals Source Type: news

EPS And EPP: Working Together To Create The Best Qualified Packaging Has To Offer
When it comes to packaging for the cold chain, two important questions to consider are whether the packaging will hold its temperature and if it is durable enough to handle rough handling and multiple uses. Temperature stability and hold times are expected functions of any packaging system. And, today’s EPS based platforms do the trick. How many companies differ is in the pack out configuration of these systems (ie refrigerants, wall thickness, weight, cost, sizes, etc). (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - March 29, 2016 Category: Pharmaceuticals Source Type: news