News

PTM Consulting news collection and Case Histories

EMA News – QbD: New EMA Guideline on Manufacture of the finished Dosage Form

QbD: New EMA Guideline on Manufacture of the finished Dosage Form The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document. This guideline will update the previous guideline “Note for Guidance on Manufacture of the Finished Dosage Form” that was originally adopted…

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DDP – Drug Delivery Partnerships, Palm Beach Gardens (FL) – February 7-9, 2017

PTM Consulting attended one of the most important american event for Durg Delivery. For 21 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies. One of the hot topic concerned the impact of new technologies on medical device. The Digital Health that merges…

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Pharma PPM Toolbox – London, 2nd & 3rd march

PTM Consulting attended as Silver Sponsor the 7^ edition of the “Pharma PPM Toolbox” in London, the world’s biggest pharmaceutical PPM conference. Paolo Mazzoni, founder and CEO of PTM, presented “Project Portfolio Management, Decision and Risk: a Holistic Approach”. Visit the conference website.  

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Case Study: Tablet reformulation Technology Transfer / Scale-up

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: TABLET Needs: Modify tablet formulation and meet several reference features Modify manufacturing processes Reduce costs Increase market competitiveness Actions: Quality Risk Management including Process Mapping Design of Experiment Situation To reduce costs and increase market competitiveness, a global pharmaceutical company decided to modify the formulation and some manufacturing process stages for a drug in tablet administration form. Some main objectives were to meet the reference…

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Case Study: Dry Powder Inhaler Scale-up

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: MULTIDOSE DRY POWDER INHALER Needs: Scale-up the productivity of the molding and assembly manufacturing processes Scale-up the productivity of the drug product formulation process Keep Quality Costs within budget Complete the project in a timely and cost effective manner Actions: Project Risk Management Design for Manufacturing Project and Quality Risk Management Design of Experiment Situation A leading global pharmaceutical company wanted to scale-up the moulding,…

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Notiziario Chimico Farmaceutico

Link permanente al sito della maggiore rivista italiana del settore Life Cycle. Su questo post ragguaglieremo circa gli interventi che PTM Consulting si pregia di effettuare con assiduità da alcuni anni. Abbiamo in programma articoli complessi ed interventi più rapidi. Trovate qui l’intervento del mese di Novembre 2013 La qualità come progetto per crescere è il titolo dell’interessante intervista pubblicata sulla rivista NCF del mese di Novembre 2013 dove la…

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Case Study: Integrated Quality Risk Management

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: COMBINATION PRODUCT Needs: Integrate Quality Risk Management and Quality System Management (R&D and Manufacturing) Increase company’s process/product knowledge Reduce project cost, time, and resource investment and future investment Actions: Business Risk Assessment & Planning Guideline Implementation Phase SOP Implementation Phase & Continuous Improvement Situation In the last few years, regulatory authorities set a new and even higher bar of mandatory quality for pharmaceutical companies. Part…

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Associazione Farmaceutici Industria

Permanent link to the AFI web site. Every year PTM Consulting stands at the AFI Simposio which takes place during the month of June at the Rimini Palacongressi. On this post you’ll find more information about our participation at the important meeting that in 2014 comes to the 54th edition. Find here the presentation of the meeting 54° appuntamento – Simposio AFI Giugno 2014. www.afiscientifica.it

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Acronyms

Download the entire list. TERM COUNTRY DEFINITION AADA Int Abbreviated Antibiotic Drug Application AAPS US American Association of   Pharmaceutical Scientists ABC US American Botanical Council ABPI UK Association of British   Pharmaceutical Industries ACSI US American Customer Satisfaction Index ADME Int Absorption, Distribution,   Metabolism, and Excretion ADR Int Adverse Drug Reaction AF Int Application Form AFI IT Associazione Farmaceutici Industria AFSSPS FR Agence Francaise de Securite Sanitaire des…

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Case Study: Knowledge Acceleration

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: DEVELOPMENT OF NEW ASSEMBLY PROCESS FOR A NEW DRUG DELIVERY SYSTEM Needs: Transfer the existing technology to a new CMO Develop a second generation of the process in order to increase the manufacturing volume and increase the product quality Actions: Process mapping and modeling Process knowledge generation and deployment Situation A global pharmaceutical company needed to transfer a semi-automated production line for a new drug…

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