Top Stories
More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.
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FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
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Industry News
Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.
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FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.
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Supplier News
SGS Life Sciences expands chemistry and microbiology testing services after acquisition of Quality Compliance Laboratories.
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Colorcon acquires Paulaur Corporation, a manufacturer of specialty sugar-based ingredients.
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Cost Effective Solutions to Develop and Manufacture Product
INTERPHEX is a premier pharma, bio and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the full product development life cycle. Join us in New York, April 26-29, 2016. Register for your complimentary Technical Education and Exhibit Hall Pass Today at  www.INTERPHEX.com/Register. Discover what’s NEW at #INTERPHEX. |
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Bio/Pharma News
Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.
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FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.
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Regulatory News
The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.
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Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.
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Best Practices for Effective Product Transfer
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Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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FEATURED TOPICS |
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VALIDATION
The author discusses the collection and evaluation of data part of FDA’s definition of process validation.
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VIEWPOINTS
Infrastructure and payer decisions will determine drug choices in emerging and developed regions.
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PACKAGING FORUM
Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
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EUROPEAN REGULATORY WATCH
Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Thursday, February 11, 2016 at 8 am PST / 10 am CST / 11 am EST
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
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WebcastS
On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency’s Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ
On Demand
In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services
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on pharmtech tv
A Conversation with AAPS Executive Director, Walt Marlowe
Addressing Pharma Industry Issues
The Transition from Paper Records to Electronic Batch Records
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Events
February 2-4, 2016
February 21-25, 2016
March 14-16, 2016
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REFERENCE BOOKS |
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A compilation of articles from Pharmaceutical Technology in a three-handbook set covering methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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