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Webcast: Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational Efficiency (June 11) Sponsored by Sparta Systems Webcast: Regulatory, Biosafety, and Clinical Considerations for Vaccine Development (June 11) Sponsored by SGS Life Science Services Achieving Raw Material Transparency in the Pharmaceutical / BioPharmaceutical Supply Chain (June 18) Sponsored by SAFC Risk Mitigation Strategies for API Manufacturing in Emerging Markets (June 19) Sponsored by Neuland Laboratories More Webcasts BIT's 4th Annual Global Congress of Catalysis - 2013 June 29-July 1, 2013 China Pharma Trials World Korea 2013 July 8-11, 2013 South Korea Advertisement: Pharmaceutical Technology presents its Process Analytical Technology resource guide combo A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology to be more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects. Click here

June 6, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis The author examines dry dispersion and outlines the related analytical method development. (Peer-reviewed paper). Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry. (Peer-reviewed paper). Manufacturers Seek Strategies for Life-Cycle Approach to Process Validation A recent PDA workshop helped manufacturers who are wrestling with and working to implement the FDA’s process validation guidance. Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections. UPM Acquires Former Pfizer Facility Pfizer had gained the facility through its previous acquisition of King Pharmaceuticals. CPhI Announces Members for Expert Industry Panel A new panel will create reports that assess changes in the pharmaceutical industry. Advertisement: Pharmas and consumer healthcare organizations can benefit from the increased product safety, compliance, cost-savings and marketability offered by stick-pack packaging of Rx and supplements. Read "Stick-pack Benefits for Pharmaceuticals and Nutraceuticals," a whitepaper by Ropack's Paul Dupont. Visit www.ropack.com to learn more about Ropack's $9M, 15,000-sq-ft facility dedicated to stick-pack packaging of temperature- and humidity-sensitive products. ISTA Pharmaceuticals Pleads Guilty to Federal Felony Charges ISTA will pay $33.5 million to resolve criminal liability and false claims allegations. Advertisement: Support and Solutions from Agilent for Impurity Profiling:  New Genotoxic Impurities Primer Agilent partners with Pharma for great results.  Download or request a hard copy of our new guide, Genotoxic Impurities in Pharmaceutical Products:  Regulations and Analysis, authored by Ludwig Huber.  The guide provides specific guidelines for genotoxic impurities and recommendations for implementation according to EMA and FDA guidelines. Get yourGenotoxic Primernow. FDA Fights Drug Shortage with Import of Injectable Nutrition Drugs FDA has announced the import of injectable drugs used in total parenteral nutrition (TPN), which have been in critical shortage. Advertisement: Download the Validation Toolkit: Get these 6 must-read articles on meeting the regulatory requirements for validation in your controlled environments including warehouses, chambers, validation master plans, protocols, and more. PLUS: Watch 3 on-demand webinars on validation/mapping studies that will satisfy inspectors and auditors. Get this Toolkit now… GSK Acquires Vaccine Platform Tech Company Okairos GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company. Sanofi Ends Development of Two Phase III Drugs Sanofi has discontinued development of two investigational drugs in Phase III development, iniparib and otamixaban, based on recent clinical results. MorphoSys and GSK Partner in Antibody Pact MorphoSys has formed a global agreement with GlaxoSmithKline to develop and commercialize MOR103, MorphoSys's proprietary HuCAL-derived antibody for treating mild to moderate rheumatoid arthritis. Dr. Reddy's and Fujifilm Halt Plans for Joint Venture The companies cancel plans to develop and manufacture generic drugs in Japan. Amgen and Astellas Form Joint Venture Amgen and Astellas have entered into a strategic alliance to provide new medicines for serious unmet medical needs of Japanese patients.

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