5 Months On – And How Are We Doing?
For those of us living in Europe, September is that month when that wonderful summer vacation taken in July and/or August is sinking ever faster from our memories.
Pricing Pressures Remain No Matter How Much The Face Of Pharma Changes
By Ranjit Jose, Director, Strategic Markets, Model N
The pharma companies that find the right mix of products to serve the needs of patient populations, meet payer expectations and, ultimately, make a profit will top the list. Getting there requires these companies rethink pharma as they know it and control their ability to price. Let’s first take a look at the key factors that are driving widespread change in the pharmaceutical industry.
Making it Happen: Project Considerations For Artwork Improvement Programs
By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward
In my first two articles in this series on change and program management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement program and some of the change management aspects to consider in order to ensure the change is delivered in a sustainable way. In this article, I will look at the design of individual improvement projects to ensure effective delivery.
5 Questions To Ask Yourself Before The Inspectors Do
Since the FDA began releasing its annual Summary of Inspection Observations report in 2006, the number one cited observation in FDA 483s every year has been quality control unit failures. The second most cited FDA observation, failure to thoroughly review unexplained discrepancies/meet expectations, is also the most frequently cited observation by Europe’s Medicines and Healthcare products Regulatory Agency (MHRA). In order to measure your GMP compliance, as well as the effectiveness of your processes and people, ask yourself the following five questions.
Strong Data Is Generated By Strong People
By Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
PHARMA MANUFACTURING INSIGHTS
Viscometer vs. Rheometer: Which Is The Better Choice?
This is the type of query that comes in from customers to instrument manufacturers on a frequent basis. It may go somewhat like the following set of statements and questions.
Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high speed lines have been designed to supply the patients with “multipurpose” small molecules drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer. By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
What’s The Impact Of Big Data In The Cold Chain?
Anywhere you look these days, people talk about big data. Whether you are in the technology industry, the retail industry, the supply chain and logistics industry, or any other industry, there is no doubt that big data plays a part.
Sterilizing Filtration Of Enriched And Pure Gaseous Oxygen Employed In Cell Culture Applications
Modern bioreactor aeration concepts increasingly using oxygen-enriched air or pure oxygen gas to improve cell culture productivity. As with air, these alternate oxygen source gas feeds must be filtersterilized to prevent spoilage of bioreactors by contaminant organisms coming from the incoming and outgoing gas streams. Membrane filters are used to sterilize these gases, and must also be integrity testable to assure process security and meet GMP requirements.
Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies
Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners.
Extracting the Value From Outsourcing By Applying Best Outsourcing Practices
By its very nature, outsourcing can be a double-edged sword. On one hand you could consider outsourcing as an approach to increase your geographic reach, retain organizational flexibility or a smaller footprint, or achieve some other business goal.
Biopharma’s Needs And Focus Of Small Sponsors
In this day and age of preferred service provider relationships and/or functional service providers, small pharmaceutical and biotechnology companies present a unique challenge to service providers vying for their business. The resource constraints (both money and people) and time lines are critical, given a narrow or single product development pipeline, little to no revenue stream, and a hyperfocused management team. While these issues may not be unique to small companies, oftentimes the viability of a project, and possibly the company, may lie within two critical aspects — the people and on-time delivery of the project.
PHARMACEUTICAL ONLINE VIDEOS
Contract Solid Dose Packaging Services for Pharmaceutical and Consumer Healthcare
Contract packaging for pharmaceutical and consumer health-care is Ropack's core service. Global customers rely on our exacting production environments — 32 Class 100000 Clean Rooms, including a dedicated facility ensuring low RH and controlled temperature. With four production facilities totaling nearly 250,000 square feet, Ropack has ample capacity, state-of-the-industry technology and the flexibility to provide stability and commercial production in short and long runs.
Clinical Trial Distribution Reduces Costs and Shortens Go-To-Market Timelines
Ropack's in-Canada clinical trial distribution reduces costs and shortens go-to-market timelines while ensuring accuracy and the highest level of security. When pharmas and CROs send bulk product, Ropack purchases components in country and eliminates the governmental red tape and associated cost of shipping from out of country.
FlexAct® MF is the first automated system for single-use manifold bag filling in biopharmaceutical processes. The system combines high accuracy and reproducible filling. With its automatically-generated batch record and individual bag label, traceability is secured.
Who Is LoJack SCI?
LoJack is a division of the well-known LoJack. This video highlights benefits of partnering with LoJack SCI such as a 25 year law enforcement partnership, SC-ISAC, the only federally sanctioned source of info on threats to your supply chain and cargo.
LoJack's Unique Relationship With Law Enforcement
LoJack SCI hold a unique relationship with Law Enforcement. They've been working with them for over 25 years. All Law Enforment recognizes the LoJack SCI brand as a trustworthy partner. They are also leaders in the industry.
Lilly and Novast To Expand Manufacturing Capabilities In China
Eli Lilly and partner Novast Laboratories announced they will expand manufacturing and development capabilities in Nantong, China. The planned expansion is part of the companies’ collaboration to develop a line of Lilly-branded generics.
We are a global market leading provider of an air cargo cold chain transportation concept to pharmaceutical companies and their logistics partners. We are unique and the benchmark for global air cargo cold chain management and logistics solutions.
Norwich Pharma Services
Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries. We combine comprehensive services, exceptional customer focus, and the highly-respected resources and reputation of Norwich to offer a complete range of Clinical Services.
CAMO Software, Inc.
CAMO Software is a pioneer and trusted market-leader in the field of Multivariate Analysis (MVA) and Design of Experiments (DoE) software. Our solutions are used by companies around the world to analyze data and monitor key processes in R&D, Manufacturing and Quality Control.
Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
The Information Source for the Pharmaceutical Manufacturing Industry
Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.
Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.
Quality & Manufacturing
This 15-Minute Guide describes how unifying, simplifying, and automating the management of controlled documents can create an efficient, flexible, and compliant manufacturing operation.
This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs.
Accelerate Regulatory Submission Documentation Creation, Review And Approval
Streamlining the regulatory submission process is essential to getting products to market faster, and many organizations use a document management system to support these activities.
Universal Drum Clamp System
Servolift's Universal Drum Clamping System is the cleanest, strongest and most reliable drum handling system
Drum Transfer System Flexible Containment for offloading drummed materials in a safe and efficient manner is provided by the Drum Transfer System (DTS) platform.
NS3110: Homogenizer And High Pressure Pump The NS3110 high pressure homogenizer and pump is the state-of-the-art technology for powerful reliable high pressure machines and customized solutions.
DVS Advantage (Dynamic Vapor Sorption): Particulate System DVS Advantage combines the best in microbalance, gas flow and vapor measurement technologies to deliver unsurpassed performance in terms of experimental design as well as instrument accuracy and repeatability.
Food and Pharmaceutical Metal Detector: Vistus®
With Vistus® , Sartorius is setting new standards in user friendliness and performance power. Thanks to the use of high-quality components and an enormously wide range of frequencies, the Vistus® series delivers maximum detection performance and reliability.
UPCOMING TRAINING COURSES
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LIFE SCIENCE WEBINARS
H.R. 3204 Drug Quality And Security Act
After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.
Top Things To Consider When Evaluating Your Vendor’s Security Of Supply Strategies
The biopharmaceutical industry’s increasingly complex global supply chains, often involving single-source supplier arrangements, are made vulnerable by uncertain financial environments and unpredictable natural disasters.
Successfully Managing The Risks And Challenges Of Orphan Drugs
Orphan drugs, while life changing and in many cases life saving for patients, are fraught with challenges for biotech and pharmaceutical manufacturers. These range from locating the patients and their physician caregivers, to making sure the patients can pay for these therapies, to the overcoming the numerous risk points in moving very expensive and in most cases temperature controlled goods to patients all over the globe. This webinar looks at addressing these issues. The experienced speakers will guide you through the salient points and considerations when dealing with these challenges.
03.11.14 -- Novartis And Roche Fined $251 Million By Italian Government
03/11/14 Pharmaceutical Online Newsletter
03.06.14 -- Ron Guido Offers Advice On Supply Chain Security
03/06/14 Pharmaceutical Online Newsletter
03.04.14 -- Pharmaceutical Online Newsletter
03/04/14 -- Pharmaceutical Online Newsletter
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Webinar on How to Achieve Adherence to Standard Operation Procedures (SOP) by Global Compliance TrainingsMarch 11, 2014
Holiday Inn Regents Park, London