Software Solutions For Future Challenges Of Pharmaceutical Plants
With COMOS, Siemens delivers a comprehensive software solution for the optimal integration of engineering and operation.
FDA And Industry Experts Offer Guidance For DQSA Preparation
It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.
Use Of Efficiency Tools In MES And Automation Projects
In this era of high technology, many traditionally cumbersome and time-consuming project tasks can be managed more effectively if they are identified up front and the right engineering tools are developed and employed.
Why Monitoring Cold Chain Data Is Not Enough
In the cold chain logistics industry there’s a huge change happening. Lots of data is being gathered by wirelessly connected data loggers, sensors and monitoring equipment. By Nitin Dahad, Dyzle
Key Points Of FDA's Draft Guidance On Manufacturing Quality Agreements
By Laurie Meehan, Polaris Compliance Consultants, Inc.
Last year, FDA published its draft guidance, officially titled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”. Here are some of the highlights.
PHARMA MANUFACTURING INSIGHTS
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.
Building Strategic Partnerships With CROs For Businesses Of All Sizes
As strategic partnerships become a greater focus for both sponsors and CROs, there are some concerns that these types of relationships will negatively impact the industry by causing a greater imbalance in an already perceived to be unbalanced playing field. These worries tend to come from, and impact, the smaller players in the market. Smaller clients of big CROs worry their projects will receive significantly less attention than the CROs’ strategic partnerships. Small CROs worry there won’t be a place for them in the industry, because they do not have as broad an offering and are unable to provide support across the entire development cycle.
Medical Device Package Inspection Case Study
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products.
4 Power-Thinking Strategies Of Centered Leaders
The life sciences world has enjoyed many decades of solid success, manifested in a culture of a fairly stable, predictable environment. Unfortunately, pace and predictability in the industry are changing significantly, challenging also the typical work culture.
PHARMACEUTICAL ONLINE VIDEOS
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 SCI | 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.
LoJack SCI | Exclusive RF Assisted Solutions
LoJack SCI's event-based comprehensive solutions integrated with the recovery-based beaconing technology create unique proactive protection for your products. This directionally based RF component adds the only technology solution that will generate search warrants due to the accuracy level of RF.
Comprehensive Supply Chain Integrity Solutions
This video highlights its comprehensive supply chain integrity solutions. Event based protocols and notifications, real-time condition of goods reports and layer security with RF Technology.
Novartis And Roche Fined $251 Million By Italian Government
The Italian government fined drug industry giants Novartis and Roche $251 million dollars for their roles in a collusion plot to prevent Roche’s Avastin cancer drug from being used as a treatment for a disease affecting aging eyes.
Micromeritics Instrument Corporation
Micromeritics manufactures a broad line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production, and process control applications.
CSafe Global is the only global provider of a full line of cold chain solutions and is the world’s largest producer of actively controlled mobile refrigeration units for life sciences, healthcare, military and international disaster relief agencies.
World Courier Inc. World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Bioquell is a world leader in the field of biological decontamination providing expert assistance in contamination control issues, from initial consultations to project implementation and validation.
PHARMACEUTICAL ONLINE SUPPLEMENTS
The Information Source for the Pharmaceutical Manufacturing Industry
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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.
Elzone® II 5390 The new Elzone® II 5390 determines particle size by using the highly accurate and reproducible electrical sensing zone method which is widely recognized as a highly effective method of counting and sizing a wide variety of organic and inorganic materials
Steam Sterilizers With Horizontal Chamber
FOB steam sterilizers are fully configurable with a variety of options, these autoclaves are the most flexible solution for all the applications in laboratory, industry and healthcare fields.
Industrial Vision System & Smart Camera: In-Sight 5000
The unprecedented vision power and unmatched ruggedness of the In-Sight® 5000 series of vision systems help manufacturers around the world improve productivity, ensure product quality and lower manufacturing costs.
Syloid® FP Silica Excipients
Syloid® FP silicas are the intelligent choice for many pharmaceutical applications due their unique morphology. The combined adsorption capacity, porosity, particle size, and greater internal surface area allow it to provide several benefits simultaneously that can help minimize the number of excipients required, expedite manufacturing, and improve efficacy of the final dosage form.
Roller Compactor Rentals
By renting a GERTEIS unit you can test our dry granulation equipment and see for yourself how well the machine works before making a definite purchase decision.
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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.
03.06.14 -- 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
02.27.14 -- Pfizer Faces Regulatory Action From Australian Government
02/27/14 Pharmaceutical Online Newsletter