News

News

NEWS

The PTM response to nitrosamine presence

a risk-based approach for the nitrosamines evaluation for Marketing Authorization Holders In June 2018, authorities in the EU became aware of the presence of a nitrosamine, N-nitrosodimethylamine (NDMA), in valsartan from one manufacturer of active pharmaceutical ingredients (APIs). Subsequently another nitrosamine, N-nitrosodiethylamine (NDEA), was detected and other sartans from more API manufacturers were later implicated. NDMA and NDEA are classified as probable human carcinogens and their presence in sartans was,…

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Published the new guideline ICH Q12: “TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT” – Draft version

ICH published the draft version for public consultation of the new guideline ICH Q12: “TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT”. This new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines and it is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.…

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EMA: Amsterdam will be EMA new location

The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken today by the EU 27 Member States in the margins of the General Affairs Council (Art.50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. Read the EMA article concerning the relocation.

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Data without integrity is just numbers: a risk-based approach to Data Integrity

Data without integrity is just data Systems compliance strategy  according to Data Integrity and Software Selection in QbD PTM Consulting developed a methodology to support companies to build appropriate Data Integrity strategies, with a new  approach, integrated to the company Quality System and based on sound risk analysis and management, according to the principles of the Q9. Systematic and versatile, the methodology  can be used during the design phase of…

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Risk Assessement for Reagents and Solvents

Risk Assessment for Reagents and Solvents Optimize the management of reagents and solvents within laboratories. Since 2014, many companies have decided to use this service to verify their proper management in daily use of their laboratories; PTM Consulting, a leading company in Life Science, applied its long lasting experience in risk management and innovation attitude to create a new service: Risk Assessment for Reagents and solvents. This  service provides a…

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Risk Management for Glass Primary packaging

Pharma Glass Primary Packaging Risk Mangement Risk-based strategic services  for Glass Primary Packaging manufacturers and pharma companies. Over the years, PTM has gained specific experience in several areas including the Pharma Glass Primary Packaging Process, from production to use in pharma companies, developing a strong expertise in plant and process analysis of glass packaging in the pharmaceutical field. Ptm experience in risk management for Pharma Glass Primary Packaging Industry provides…

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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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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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