http://pharmtech.findpharma.com/pharmtech A publication providing practical information on pharmaceutical manufacturing. Content focuses on applied R&D technology, process control and computer-integrated manufacturing, biotechnology and technical management. 2009-07-03T23:13:46Z http://pharmtech.findpharma.com/pharmtech/News/FTC-Issues-Report-on-Authorized-Generics/ArticleStandard/Article/detail/608013?ref=25 The Federal Trade Commission (FTC) last week issued an interim report that examined the effects of authorized generics on competition in the prescription drug market. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608013null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-and-Chroma-Form-Devel/ArticleStandard/Article/detail/607999?ref=25 Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more... 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607999null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/US-Marshalls-Seize-Caracos-Drug-Products-at-Three-/ArticleStandard/Article/detail/608010?ref=25 On June 25, US Marshalls seized all drug products and ingredients at three facilities of Caraco Pharmaceutical Laboratories. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608010null HTML http://pharmtech.findpharma.com/pharmtech/Technology-Approaches-to-Quality-Management---Spar/ArticleStandard/Article/detail/608577?ref=25 Technology Approaches to Quality Management - Sparta Whitepaper 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608577null PDF http://pharmtech.findpharma.com/pharmtech/Manufacturing/USP-Collaborates-with-Asian-Authorities/ArticleStandard/Article/detail/608009?ref=25 This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608009null HTML http://pharmtech.findpharma.com/pharmtech/News/UK-Strengthens-Drug-Supply-Chain/ArticleStandard/Article/detail/608006?ref=25 The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's drug supply chain. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/608006null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Cleaning-Validation-for-Pharmaceutical-Manufacturi/ArticleStandard/Article/detail/515954?ref=25 Pharmaceutical manufacturers must validate cleaning processes and be compliant with current good manufacturing practices for finished pharmaceuticals as stated in 21 CFR Subpart D 211.67—equipment cleaning and maintenance. Validation is a documented guarantee that cleaning can be performed reliably and repeatedly to satisfy a predetermined level of cleanliness. This whitepaper addresses residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, recovery studies, writing procedures and training operators. 2009-07-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192008/515954null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Avoiding-Project-Delays-Caused-by-Formulation-Chan/ArticleStandard/Article/detail/607230?ref=25 For pharmaceutical manufacturing companies, every decision in the product development process can impact the project outcome. By working closely with a reliable Contract Research Organization, clients can take the necessary precautions to avoid risks throughout the development program. A new white paper from SP Formulations, titled "Freeze! Avoid Catastrophic Project Delays Caused by Formulation Changes", presents some of the problems associated with 'simple' formulation changes. In addition to providing guidance on outsourcing drug development needs, the white paper presents a case study detailing the alternative approaches available for formulating a lyophilized product. 2009-06-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607230null REMOTE http://pharmtech.findpharma.com/pharmtech/Booth-Preview/ArticleStandard/Article/detail/607201?ref=25 2009-06-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/272009/607201null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/Watson-to-Acquire-Arrow-for-175-Billion/ArticleStandard/Article/detail/606176?ref=25 Generic-drug and specialty pharmaceutical manufacturer Watson Pharmaceuticals (Corona, CA) agreed to acquire the generic-drug company Arrow Group for $1.75 billion in cash and stock. 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606176null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Aqueous-Cleaning-for-Pharmaceutical-Applications/ArticleStandard/Article/detail/476613?ref=25 To streamline regulatory compliance, the desirability of using as few cleaners as possible to remove the entire range of residues encountered in pharmaceutical manufacturing — from water-soluble excipients to difficult-to-clean petrolatum/metal oxide mixtures — is explored in the standard industry text, The Aqueous Cleaning Handbook. Cleaning validation guidelines and key factors in establishing sound GMP and cGMP procedures are discussed. Explaining how aqueous cleaners work in a wide range of cleaning procedures, the text covers manual, soak and ultrasonic cleaning as well as clean-in-place (CIP) spray systems. Tables for chemical formulations, types of cleaning methods, and aqueous cleaning agents are included. A useful, in-depth reference whether you are cleaning bench scale lab apparatus used for trials to full-scale bulk manufacturing equipment. 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/482007/476613null REMOTE http://pharmtech.findpharma.com/pharmtech/Regulation/Former-Senate-Leaders-Support-Follow-On-Biologics-/ArticleStandard/Article/detail/606161?ref=25 Former Senator Majority Leaders Howard Baker, Tom Daschle, and Bob Dole released a report this month, Crossing Our Line: Working Together to Reform the US Health System, which proposes four pillars of health reform. 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606161null HTML http://pharmtech.findpharma.com/pharmtech/News/Sunshine-Act-Still-Pending-before-Senate-Committee/ArticleStandard/Article/detail/606159?ref=25 The Physician Payments Sunshine Act is still pending before the US Senate Committee on Finance, according to Jill Kozeny, communications director for Senator Chuck Grassley (R-IA). 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606159null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/European-Fine-Chemicals-Group-Issues-Assessment-To/ArticleStandard/Article/detail/606178?ref=25 Following the 2008 launch of the European Fine Chemicals Group (EFCG) Voluntary Guidelines (VGs) to promote supply-chain security, the group has now announced the official launch of an assessment template that will allow fine chemicals customers and suppliers to assess and implement this new set of recommendations. 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606178null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Synta-and-GSK-End-Agreeme/ArticleStandard/Article/detail/606500?ref=25 Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more... 2009-06-25T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/606500null HTML http://pharmtech.findpharma.com/pharmtech/New-FDA-and-ICH-Guidelines/ArticleStandard/Article/detail/605406?ref=25 This section lists final and draft guidances issued by the US Food and Drug Administration and the International Conference on Harmonization from Jan. 2008 through Apr. 2009. 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605406null PDF http://pharmtech.findpharma.com/pharmtech/Avoiding-Project-Delays-Caused-by-Formulation-Chan/ArticleStandard/Article/detail/605324?ref=25 Avoiding Project Delays Caused by Formulation Changes-SP Formulations Whitepaper 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605324null PDF http://pharmtech.findpharma.com/pharmtech/Approved-New-Molecular-Entities/ArticleStandard/Article/detail/605350?ref=25 This section of PharmTech's 2009 Industry Almanac lists the approved new molecular entities from Jan. 2008 through Apr. 2009. The company names, brand names, dosage forms, and indications are included. 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605350null PDF http://pharmtech.findpharma.com/pharmtech/Industry-Spending-Facts/ArticleStandard/Article/detail/605416?ref=25 This section reviews key issues regarding equipment and machinery spending, including a comparison of actual 2008 spending and projected 2009 spending. 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605416null PDF http://pharmtech.findpharma.com/pharmtech/Online+Exclusives/FDA-Commissioner-Hamburg-Discusses-Drug-Regulation/ArticleStandard/Article/detail/605500?ref=25 The new commissioner of the US Food and Drug Administration is mapping plans for turning around an agency that has been demoralized, buffeted about in the press and has lost some of the trust of the American people. 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605500/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605500null HTML http://pharmtech.findpharma.com/pharmtech/Industry-Events-for-2009ndash2010/ArticleStandard/Article/detail/605349?ref=25 This section of the almanac features upcoming events for 2009 and 2010. 2009-06-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/262009/605349null PDF http://pharmtech.findpharma.com/pharmtech/Ingredients/FTC-Report-on-Follow-on-Biologics-Sparks-Congressi/ArticleStandard/Article/detail/604402?ref=25 The Subcommittee on Health of the US House of Representatives Energy and Commerce Committee held hearings last week to discuss the findings of a report by the Federal Trade Commission (FTC) that examined the competitive effects for follow-on-biologics (FOBs). 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604402null HTML http://pharmtech.findpharma.com/pharmtech/News/Harmonization-Steps-Move-Forward-in-Tokyo/ArticleStandard/Article/detail/604405?ref=25 Last week, the steering committee and expert working groups of the International Conference on Harmonization met in Yokohama, Japan, to discuss pending guidelines and other relevant issues. 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604405null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Industry-Health-Agencies-Respond-to-Influenza-Pand/ArticleStandard/Article/detail/604398?ref=25 Following the World Health Organization's declaration last week of an influenza pandemic, vaccine makers in Europe and China as well as world health agencies are stepping up efforts toward rapid development and approval of an effective vaccine. 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604398null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Dr-Reddy-and-GSK-Form-Pac/ArticleStandard/Article/detail/604472?ref=25 Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more... 2009-06-18T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/604472null HTML http://pharmtech.findpharma.com/pharmtech/Article/Could-We-Make-Large-Molecules-with-Less-Labor/ArticleStandard/Article/detail/603746?ref=25 The emergence of influenza A (H1N1) and the efforts to provide vaccines to the vulnerable are timely examples of biopharmaceuticals' continuing importance. 2009-06-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/603746null HTML http://pharmtech.findpharma.com/pharmtech/Article/June-2009-Editors-Picks-Products-from-Bullard-and-/ArticleStandard/Article/detail/603608?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Bullard and Teledyne Tekmar. 2009-06-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/603608null HTML http://pharmtech.findpharma.com/pharmtech/Formulation/Draft-Guidance-Issued-for-Injectors-Development/ArticleStandard/Article/detail/603740?ref=25 To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 2009-06-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/252009/603740null HTML http://pharmtech.findpharma.com/pharmtech/News/Kemwell-To-Build-Biologics-Manufacturing-Facility-/ArticleStandard/Article/detail/602702?ref=25 Kemwell (Bangalore, Karnataka, India) plans to build a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim (BI, Ingelheim, Germany), according to a Kemwell press release. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602702null HTML http://pharmtech.findpharma.com/pharmtech/News/Mylan-COO-Testifies-on-Pay-to-Delay-Patent-Settlem/ArticleStandard/Article/detail/602700?ref=25 The chief operating officer (COO) of Mylan (Canonsburg, PA), one of the world's leading generic drug manufacturers, has condemned the launch of authorized generic drugs during 180-day exclusivity periods. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602700null HTML http://pharmtech.findpharma.com/pharmtech/News/GAO-Recommends-That-FDA-Ensure-Data-Security-withi/ArticleStandard/Article/detail/602699?ref=25 The US Government Accountability Office recommended that the US Food and Drug Administration draft a plan, including milestones, for developing its Sentinel system and ensuring the privacy and security of patients' healthcare data. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602699null HTML http://pharmtech.findpharma.com/pharmtech/News/European-Commission-Wont-Pursue-Directive-for-Exci/ArticleStandard/Article/detail/602697?ref=25 The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602697null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-CSL-and-Talecris-Terminat/ArticleStandard/Article/detail/602720?ref=25 Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more... 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602720null HTML http://pharmtech.findpharma.com/pharmtech/Online+Exclusives/Report-From-India-A-new-patent-battleground-has-fo/ArticleStandard/Article/detail/603163?ref=25 Patent infringement claims and a lack of clear global trade distribution routes may be unraveling the country's generic-drug export industry. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/603163null XML http://pharmtech.findpharma.com/pharmtech/News/Draft-Guidance-Issued-for-Injectors-Development/ArticleStandard/Article/detail/602698?ref=25 To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602698null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Issues-Guidance-on-Medication-Guide-Statements/ArticleStandard/Article/detail/602695?ref=25 The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602695null HTML http://pharmtech.findpharma.com/pharmtech/News/MHRA-Seeks-Improved-Legislative-Framework/ArticleStandard/Article/detail/602701?ref=25 The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has published the results of its concept paper that sought comments regarding the review and consolidation of the UK medicines legislation. 2009-06-11T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/242009/602701null HTML http://pharmtech.findpharma.com/pharmtech/Article/Best-Practices-in-the-Supply-Chain/ArticleStandard/Article/detail/601481?ref=25 Consumer-care products, electronics, and select industrial firms comprise AMR Research's Supply Chain Top 25 for 2009, offering an opportunity for the pharmaceutical industry to examine best practices in supply-chain management. 2009-06-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601481null HTML http://pharmtech.findpharma.com/pharmtech/Article/Bleak-Times-for-the-Global-Biotech-Industry/ArticleStandard/Article/detail/601471?ref=25 The US biotechnology industry reached aggregate profitability for the first time ever in 2008, representing the only bright spot in an otherwise dismal year for biotechnology financing and performance. 2009-06-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601471null HTML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Limits-to-Growth/ArticleStandard/Article/detail/601914?ref=25 A major CRO ventures further into proprietary drug development. 2009-06-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601914null XML http://pharmtech.findpharma.com/pharmtech/THE-IMPORTANCE-OF-ON-DOSE-TECHNOLOGIES-IN-THE-FIGH/ArticleStandard/Article/detail/601784?ref=25 THE IMPORTANCE OF ON-DOSE TECHNOLOGIES IN THE FIGHT AGAINST MISUSE, ABUSE AND ILLEGAL DIVERSION OF OPIOIDS-NanoGuardian Applicaion Note 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601784null PDF http://pharmtech.findpharma.com/pharmtech/News/House-Introduces-Discussion-Draft-for-Drug-and-Foo/ArticleStandard/Article/detail/601252?ref=25 Members of the House Committee on Energy and Commerce, Chair Emeritus John D. Dingell (D-MI), Chair Henry A. Waxman (D-CA), and Reps. Frank Pallone (D-NJ), Bart Stupak (D-MI), Diana DeGette (D-CO) and Betty Sutton (D-OH) released last week a discussion draft of the Food Safety Enhancement Act of 2009. 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601252null HTML http://pharmtech.findpharma.com/pharmtech/News/US-and-16-States-Sue-Wyeth-over-Medicaid-Discounts/ArticleStandard/Article/detail/601246?ref=25 In two whistleblower suits filed in May 2009, the United States and 16 states alleged that Wyeth (Madison, NJ) knowingly failed to offer the government the same discounts it gave to private purchasers of its drugs, as Medicaid laws require. 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601246null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-AstraZeneca-and-Merck-Col/ArticleStandard/Article/detail/601645?ref=25 Also, WACKER expands Iowa facility; EMEA releases a Q&A document for PIPs; Metrics consolidates quality operations; more... 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601645null HTML http://pharmtech.findpharma.com/pharmtech/News/EU-May-Change-Direct-to-Consumer-Rules/ArticleStandard/Article/detail/601259?ref=25 The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) is seeking opinions on a European Commission (EC) proposal that would allow drugmakers to disseminate certain information on prescription medicines directly to European Union patients. 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601259null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Issues-Guidance-on-Submitting-Establishment-Re/ArticleStandard/Article/detail/601247?ref=25 This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing. 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601247null HTML http://pharmtech.findpharma.com/pharmtech/News/Genetic-Link-to-Drug-Induced-Liver-Injury-Found/ArticleStandard/Article/detail/601260?ref=25 The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury, according a new FDA press release. 2009-06-04T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601260null HTML http://pharmtech.findpharma.com/pharmtech/IT/Drug-Serialization-and-Supply-Chain-Security/ArticleStandard/Article/detail/601169?ref=25 As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601169/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601169/rotate_counterfeiting_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Mapping-Opportunities-for-Patent-Positions/ArticleStandard/Article/detail/600805?ref=25 Follow-on biologics could unleash the potential of several industries and may even spark economic recovery. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600805null XML http://pharmtech.findpharma.com/pharmtech/Regulation+Article/Operator-Error/ArticleStandard/Article/detail/600806?ref=25 Short-term problems in software or hardware lead to long-term manufacturing troubles. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600806null XML http://pharmtech.findpharma.com/pharmtech/Testing+Article/Charting-a-Pathway-to-Follow-On-Biologics/ArticleStandard/Article/detail/600817?ref=25 Debates about science, manufacturing, and European regulations will shape the approval process for follow-on biologics in the United States. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600817/rotate_cover_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Report-From-Ireland/ArticleStandard/Article/detail/600811?ref=25 Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600811null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Quality-Trio-Takes-Final-Shape/ArticleStandard/Article/detail/600815?ref=25 FDA leaders explain the purpose and plan for ICH's three quality guidelines. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600815null XML http://pharmtech.findpharma.com/pharmtech/Article/In-the-Spotlight/ArticleStandard/Article/detail/600810?ref=25 Editors' Picks of Pharmaceutical Science & Technology Innovations 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600810null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Package-Design-Boosts-Patient-Compliance/ArticleStandard/Article/detail/600816?ref=25 Compliance features help patients follow medication regimens correctly. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600816/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600816null XML http://pharmtech.findpharma.com/pharmtech/Online+Exclusives/Quarantine-at-a-Glance/ArticleStandard/Article/detail/601628?ref=25 A successful quarantine program requires collaboration among all departments of a pharmaceutical facility. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601628/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601628null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/Pharma-Capsules/ArticleStandard/Article/detail/600813?ref=25 Brief pharmaceutical news items for June 2009. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600813null XML http://pharmtech.findpharma.com/pharmtech/IT/Beneath-the-Surface/ArticleStandard/Article/detail/600812?ref=25 It can take a lot of work to make sure nothing happens. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600812null XML http://pharmtech.findpharma.com/pharmtech/IT/Quality-in-Quality-Out/ArticleStandard/Article/detail/601167?ref=25 A book guides readers through the regulatory requirements for computerized quality systems. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601167/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601167null XML http://pharmtech.findpharma.com/pharmtech/IT/Truth-and-Transparency/ArticleStandard/Article/detail/600808?ref=25 Misleading the public about their investments—be it money or medicine—is unacceptable. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600808null XML http://pharmtech.findpharma.com/pharmtech/Ingredients+Insider/Outsourcing-Clinical-Trial-Materials/ArticleStandard/Article/detail/600809?ref=25 CROs and CMOs expand to gain a piece of the market for clinical trial materials. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600809/rotate_ingredients_flash.jpg XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Article/FDA-Waves-a-Big-Stick/ArticleStandard/Article/detail/600814?ref=25 Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600814null XML http://pharmtech.findpharma.com/pharmtech/Outsourcing+Outlook/Penny-Wise-Pound-Foolish/ArticleStandard/Article/detail/600807?ref=25 Pharma companies that sell redundant facilities could endanger their supply chains. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600807null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Initial-Solvent-Screening-of-Carbamazepine-Cimetid/ArticleStandard/Article/detail/601168?ref=25 The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601168/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601168null XML http://pharmtech.findpharma.com/pharmtech/Formulation+Article/Pharmacosomes-A-Potential-Alternative-to-Conventio/ArticleStandard/Article/detail/601891?ref=25 Pharmacosomes can pass through biomembranes efficiently and possess several advantages over traditional vesicular drug-delivery systems. 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601891null XML http://pharmtech.findpharma.com/pharmtech/Bulk-Inspection-of-Tablets-Symetix-Applicaton-Note/ArticleStandard/Article/detail/601279?ref=25 Bulk Inspection of Tablets-Symetix Applicaton Note 2009-06-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/601279null PDF http://pharmtech.findpharma.com/pharmtech/Online+Exclusives/FDAs-Question-Based-Review-Initiative-for-Generic-/ArticleStandard/Article/detail/600572?ref=25 The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology. 2009-05-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600572/fda_small_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600572/fda_button_flash.jpg HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Attorney-Sentenced-to-Jail-for-Illegally-Distribut/ArticleStandard/Article/detail/600069?ref=25 Last week, the US District Court in Concord, New Hampshire, sentenced 63-year-old Robert McFadden, an attorney from Palm Springs, CA, to three years of incarceration to be followed by two years of supervised release for participating in the purchase and distribution of the HIV drug Serostim (somatropin recombinant), according to a US Department of Justice press release. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600069null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Pfizer-Forms-Licensing-Ag/ArticleStandard/Article/detail/600299?ref=25 Also, Johnson & Johnson acquires Cougar Biotechnology; NIH launches program for rare and neglected diseases; PPD restructures leadership positions; more... 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600299null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/Static-Electricity-The-Hidden-Danger/ArticleStandard/Article/detail/600996?ref=25 Static Electricity is an ever-present hazard for operations and processes taking place in flammable or combustible locations. Sparking caused by electrostatic can provide an ignition source for gases, vapors and dust atmospheres. This article explains the background to the hazards of static electricity and provides some guidance as to how they may be safely avoided. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/232009/600996null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Tablet-Pro/ArticleStandard/Article/detail/517506?ref=25 Tablet Pro defines Tablet Compression in detail and its relationship to each of the manufacturing steps in preparing the formulation for compress, proper compression operations and the essence of making quality tablets. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202008/517506null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Novartis-Gains-Exclusive-Option-to-Acquire-Elixir-/ArticleStandard/Article/detail/600067?ref=25 Novartis (Basel) signed an agreement that grants the company an exclusive option to acquire Elixir Pharmaceuticals (Cambridge, MA) upon the successful completion of a Phase IIa clinical study of Elixir's lead oral ghrelin antagonist, which is now the subject of preclinical studies. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600067null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/HHS-Orders-H1N1-Vaccines-and-Vaccine-Antigen/ArticleStandard/Article/detail/600054?ref=25 The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600054null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/ADM-Plans-Green-Production-for-USP-Grade-Propylene/ArticleStandard/Article/detail/600065?ref=25 Archers Daniel Midland Company (Decatur, IL) is bringing on line a new propylene glycol plant in Decatur, Illinois, in the fourth quarter of 2009. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600065null HTML http://pharmtech.findpharma.com/pharmtech/Static-Electricity-The-Hidden-Danger-Newson-Gale-W/ArticleStandard/Article/detail/600448?ref=25 Static Electricity, The Hidden Danger-Newson Gale Whitepaper 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600448null PDF http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-Issues-Draft-Guidance-on-Presenting-Risk-Infor/ArticleStandard/Article/detail/600057?ref=25 The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600057null HTML http://pharmtech.findpharma.com/pharmtech/News/EFPIA-to-Launch-Anticounterfeiting-Pilot-in-Sweden/ArticleStandard/Article/detail/600062?ref=25 The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced a pilot program, to launch in Sweden later this year, that will focus on coding and identification solutions. 2009-05-28T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600062null HTML http://pharmtech.findpharma.com/pharmtech/Article/USP-lt231gt-Heavy-Metals-Webcast/ArticleStandard/Article/detail/600132?ref=25 The US Pharmacopeia will release for public comment a new USP <231> Heavy Metals general chapter. Is your laboratory ready to handle the changes? Find out at Pharmaceutical Technology's June 4 webinar. And check out our interactive metals and limits table. 2009-05-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/222009/600132/HeavyMetals_rotate_flash.jpg HTML http://pharmtech.findpharma.com/pharmtech/Versatrol-Controlled-Release-Softgel-Drug-Delivery/ArticleStandard/Article/detail/599418?ref=25 Versatrol Controlled Release Softgel Drug Delivery-Banner Application Note 2009-05-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599418null PDF http://pharmtech.findpharma.com/pharmtech/Manufacturing/PhRMA-Supports-Obamas-Healthcare-Reform-Initiative/ArticleStandard/Article/detail/599063?ref=25 Last Monday, Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), voiced the group's support for President Obama's efforts to reform the nation's healthcare system. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599063null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Prefilled-Syringes-Growing-More-Popular/ArticleStandard/Article/detail/599068?ref=25 According to a report from Greystone Associates in Amherst, New Hampshire, prefilled syringes are replacing vials both in terms of injections and sector revenue, and as this trend continues during the next four years, the number of tailored injectable drug products reaching the market is set to escalate. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599068null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/EMEA-Releases-Draft-Advanced-Therapy-Medicinal-Pro/ArticleStandard/Article/detail/599061?ref=25 The European Medicines Agency (EMEA) recently issued for public comment draft procedures on the evaluation of advanced therapy medicinal product (ATMPs). 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599061null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/European-Commission-Investigates-Biotech-Industry/ArticleStandard/Article/detail/599067?ref=25 More than 70% of biotechnology executives fear that the European Commission's (EC) examination of anticompetitive behavior in the pharmaceutical industry, which began in January 2008, will weaken their patent protection, according to a new Marks & Clerk report. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599067null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pharmacia-May-Pay-212M-in-Medicaid-Fraud-Case/ArticleStandard/Article/detail/599057?ref=25 Pfizer's Pharmacia unit may be ordered to pay nearly $212 million as a result of a February 2009 Wisconsin court ruling that found the company guilty of violating the state's Medicaid fraud statute 1.44 million times. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599057null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/WHO-GSK-Provide-Update-on-Pandemic-Flu-Production/ArticleStandard/Article/detail/599059?ref=25 The World Health Organization's Ad Hoc Policy Advisory Working Group on Influenza A (H1N1) Vaccines issued an update on May 18, 2009, on the production status of seasonal and A (H1NI) vaccines. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599059null HTML http://pharmtech.findpharma.com/pharmtech/News/Hamburg-to-Take-Hold-of-FDA/ArticleStandard/Article/detail/599052?ref=25 The Senate confirmed late Monday night Dr. Margaret A. Hamburg, 53, to lead the US Food and Drug Administration. 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599052null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-Teva-and-Lonza-Joint-Vent/ArticleStandard/Article/detail/599148?ref=25 Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more... 2009-05-21T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/599148null HTML http://pharmtech.findpharma.com/pharmtech/Article/Teaching-a-New-Robot-Old-Tricks/ArticleStandard/Article/detail/598567?ref=25 Automation has been part of pharmaceutical processing for some time, but robotics have not yet found wide acceptance among drugmakers. 2009-05-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/598567null HTML http://pharmtech.findpharma.com/pharmtech/Article/May-2009-Editors-Picks-Products-from-Continental-D/ArticleStandard/Article/detail/598570?ref=25 PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Continental Disc and Filimatic. 2009-05-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/598570null HTML http://pharmtech.findpharma.com/pharmtech/Article/Pharmaceutical-Packaging-and-ePedigree-Requirement/ArticleStandard/Article/detail/598569?ref=25 The US Food and Drug Administration intends to automate and enhance the safety of the pharmaceutical supply chain by establishing electronic pedigrees (ePedigrees) for drug products. 2009-05-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/212009/598569null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Requests-Largest-Ever-Budget-Increase/ArticleStandard/Article/detail/597992?ref=25 On May 7, 2009, as part of the President's fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency's current budget. 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/597992null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Company-and-People-Notes-GSK-Forms-Pact-with-Aspen/ArticleStandard/Article/detail/598063?ref=25 Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more... 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/598063null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/THE-IMPORTANCE-OF-ON-DOSE-TECHNOLOGIES-IN-THE-FIGH/ArticleStandard/Article/detail/598516?ref=25 Pharmaceutical Security Expert Dr. John Glover Argues for On-Dose Brand Protection in the Fight Against Illegal Diversion of Opioid Medications to Prevent Misuse and Abuse 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/598516null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Sanofi-aventis-To-Build-New-Vaccine-Manufacturing-/ArticleStandard/Article/detail/597995?ref=25 Sanofi-aventis announced this week that it plans to construct a new vaccine-manufacturing center in Neuville-sur-Saône, France. 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/597995null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Issues-First-Sentinel-Initiative-Project-Repor/ArticleStandard/Article/detail/597996?ref=25 The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification. 2009-05-14T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/597996null HTML http://pharmtech.findpharma.com/pharmtech/Whitepapers/HPAPI-Manufacturing-Capability/ArticleStandard/Article/detail/598449?ref=25 Richman Chemical Inc. (RCI) has tapped its capable network of partners to now offer high potency chemical manufacturing in a cGMP environment to its customers. A high potency active pharmaceutical ingredient (HPAPI) is a drug that carries a higher strength with a smaller amount of actual active pharmaceutical ingredient. Maintaining safety and efficacy while responding to the time sensitive nature inherent to life science firms needing to manufacture these HPAPIs has placed RCI in a pivotal position to respond to this growing requirement. 2009-05-13T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/202009/598449null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Aqueous-Critical-Cleaning-in-Pharmaceutical-Manufa/ArticleStandard/Article/detail/515944?ref=25 This whitepaper examines the numerous benefits of using aqueous cleaning solutions in pharmaceutical manufacturing. It also reviews the important factors involved in the aqueous critical cleaning process that need to be considered by the pharmaceutical manufacturer. 2009-05-09T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192008/515944null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Modern-tools-for-hopper-design/ArticleStandard/Article/detail/597324?ref=25 Although there are well-established methodologies for hopper design, many process engineers are uncertain as to how to measure powders in the prescribed way, extract the necessary parameters from recorded data, and successfully apply them. As a result, hopper design and the powder testing associated with it is often outsourced to specialists. This incurs significant cost and undermines the operating company's ability to troubleshoot and re-use or retrofit equipment for alternative materials or applications. 2009-05-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/597324null REMOTE http://pharmtech.findpharma.com/pharmtech/Online+Exclusives/How-to-Make-a-Swine-Flu-Vaccine/ArticleStandard/Article/detail/597284?ref=25 Covance talks about the risks, challenges, and tests required to develop a pandemic vaccine. 2009-05-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/597284/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/597284null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/Sanofi-aventis-Plans-Biopharmaceutical-Investment/ArticleStandard/Article/detail/596941?ref=25 Sanofi-aventis introduced this week its Biolaunch project at its Vitry-sur-Seine, France, pharmaceutical production site. 2009-05-07T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/192009/596941null HTML