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Eastern Analytical Symposium Nov 17-20, 2024 I am slated to provide 2 short courses as mentioned below: Nov 17: E24-05: A Holistic Approach to Life Cycle Management of Nitrosamine Drug Substance Related Impurity in Pharmaceutical Products: Guidance and Case Study https://lnkd.in/ei-iq8EM One-Day Course Sunday, Nov. 17; 8:30am – 5:00pm COURSE DESCRIPTION: Several N-nitrosamines belonging to the “Cohort of Concern” are mutagenic, genotoxic, and potentially carcinogenic agents in humans, and mandate control at acceptable safe levels. NDSRIs present a far more complexity. This course will provide a comprehensive life cycle management of sequential Predictive Chemistry of formation, organic synthesis, in-silico mutagenic and carcinogenic potential risk assessment followed by method development, validation, and confirmatory testing of sensitive analytical method based on regulatory approaches for Acceptable Intake calculation of NDSRIs. Nov 19: E24-22: Analytical Target Profile (ATP): An Introduction and its Strategic Link to Quality Target Product Profile (QTPP) and Analytical Life Cycle Management (ALCM) https://lnkd.in/e3qacSth One-Day Course Tuesday, Nov. 19; 8:30am – 5:00pm COURSE DESCRIPTION: Quality by design (ICH Q8) describes the Quality Target Product Profile (QTPP), which forms the basis for the design and development of the product. An analogous analytical term is called the Analytical Target Profile (ATP). ICH Q14 defines ATP as a method attribute that prospectively summarizes the analytical requirements of a Critical Quality Attribute (CQA). This course will present how ATP ensures method fitness for CQA with optimal bias and precision, through the product life cycle. The link of ATP to QTPP, Total Analytical Error, Critical Method Attribute and Factor, Quality Risk Management, Quality by Design, DOE, and Method Operating Design Region will be explained. Please plan to register and attend if interested to learn in either of these topics, and have engaging scientific discussions with your analytical peers.

ISPE at ACHEMA 2024 Achema is the world's largest process industry trade fair for process engineering and biotechnology. Several thousand exhibitors showcase their innovations. Pharmaceuticals have also taken up more and more space in recent years, and pharmaceutical process engineering has become an equal success factor for the pharmaceutical business alongside research. In a lecture session in Hall 4.1, ISPE experts will present current topics on technological progress and problem-solving approaches for supply chain bottlenecks: - Supply chain resilience: Activities of the European Commission in the so-called HERA initiative (European Health Emergency Response Authority), a new authority for crisis preparedness and response. Strategic measures, costs and mode of action to ensure the supply of medicines to the population in Europe. ISPE has contributed technical expertise to the conceptual work of the EU Commission. - ISPE has translated the topic of Industry 4.0 into the pharmaceutical world: a so-called "Pharma 4.0 Baseline Guide" was recently published. It addresses all the elements and enablers that need to be taken in preparation for successful digitalisation projects. Maturity assessments and case studies of successfully implemented Pharma 4.0 initiatives are shown. - Artificial intelligence and machine learning are another focus: how is GAMP (Good Automation Practice) being changed by AI? What regulatory implications need to be considered? How can legacy systems be handled? What possibilities does an "Asset Administration Shell" offer here? What role do "digital twins" play in tapping new potential for faster and lower-risk planning through simulations, for cost reductions in operations? - Regulation, compliance, governance: as a highly regulated industry, innovations in pharmaceuticals are subject to close scrutiny by the health authorities, whose task it is to ensure the safety and efficacy of medicinal products. The new approach is the "Holistic Control Strategy", which helps to reduce risks and create transparency on the path from data collection to decision-making on quality and safety-relevant data in an expanded scope and new depth of detail. Hope seeing you at ACHEMA!

‼️ USP General Chapter Prospectus: Process Analytical Technology - Definition, Attributes, Enablers, and Use Cases Posting Date: 29-Mar-2024 Input Deadline: 28-Apr-2024 💠 Background and Objectives The #USP is preparing to introduce a new General Chapter <1037> dedicated to #ProcessAnalyticalTechnology (#PAT). ➡️ The objective is to establish a comprehensive guide that aligns with current scientific and #regulatorystandards, providing clear direction for the implementation of PAT within #pharmaceutical companies. ➡️ This chapter will encapsulate the definition, core attributes, key enablers, and practically applied and modern uses of PAT, with a focus on its timeliness, sampling relevance, regulatory implications, analytical measurement integration, and the production of process- and product-relevant attributes, including #CPPs and #CQAs. 💠 Description of Scope and Application The proposed chapter will provide guidance on the integration of PAT systems within pharmaceutical processes, ensuring that the technology is leveraged effectively for #realtimemonitoring and control, #processvalidation, and #verification, as well as #productqualityassurance and release. ➡️ The scope extends to the use of PAT for process understanding and optimization, including applications in #ContinuousProcessVerification (#CPV) and #RealTimeReleaseTesting (#RTRT). ➡️The chapter will address the regulatory impact of PAT and its role in complying with quality standards. 💠 Preliminary Outline The new USP chapter will contain but not be limited to the following topics: ✅ INTRODUCTION – This section will introduce the concept of PAT and its significance in the pharmaceutical industry. ✅DEFINITION AND CORE ATTRIBUTES OF PAT – A detailed definition of PAT will be provided, along with an exploration of its core attributes. ✅KEY ENABLERS OF PAT – This section will discuss the various enablers that facilitate the effective use of PAT, such as sensors, analyzers, data-driven modelling (including #chemometrics, #machinelearning, and #AI), #processautomation, IT system integration, automated sampling technology, Design of Experiments (#DOE), and risk assessment methodologies like Failure Mode and Effects Analysis (#FMEA). ✅ REGULATORY CONSIDERATIONS – An overview of the regulatory landscape will be presented, highlighting how PAT aligns with current guidelines and standards. ✅ IMPLEMENTATION STRATEGIES – Guidance on implementing robust PAT applications in pharmaceutical manufacturing facilities will be provided. ✅ APPLICATIONS OF PAT – Case studies and examples of PAT applications in continuous process verification, continuous manufacturing, control, validation, quality assurance and RTRT will be presented. ✅ EMERGING TRENDS AND TECHNOLOGIES – The chapter will conclude with a look at emerging trends and technologies in PAT, discussing potential future directions and innovations in the field. [post author: Barbara Pirola] Link below for more information.

Troubleshooting 🌂DOE Failures in API Development 💤 When a Design of Experiments (DOE) approach fails in API (Active Pharmaceutical Ingredient) R&D, it typically indicates that the experiments didn’t yield the desired or expected results. Here’s a structured approach to address the situation: 1️⃣ Analyze the Failure: Review data and check assumptions. Re-examine chosen variables. 2️⃣ Redefine the Problem: Perform root cause analysis. Revisit the initial hypothesis. 3️⃣ Adjust DOE Design: Refine or modify the design (e.g., change factors, interactions). Expand experimental ranges if needed. 4️⃣ Iterate & Validate: Run follow-up experiments with insights from failures. Increase sample size or replications. 5️⃣ Alternative Approaches: Use machine learning or simulations to predict outcomes. 6️⃣Collaborate: Consult experts for fresh perspectives and potential solutions. #APIresearch #DOEinR&D #PharmaR&D #ExperimentalDesign #LabSolutions #ResearchAndDevelopment #APIFailures #ScientificResearch #Pharmaceuticals #ProblemSolving #LabOptimization #DOEOptimization

Illuminating #darkdata in formulations creates value throughout a pharmaceutical company. Read our latest #CASInsights article to find out how: https://ow.ly/kNAg50QiwGl

A Complete Guide of " 𝐂𝐡𝐫𝐨𝐦𝐚𝐭𝐨𝐠𝐫𝐚𝐩𝐡𝐲 𝐃𝐚𝐭𝐚 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 " [ PDF Guide ]   ➤ 𝐂𝐥𝐢𝐜𝐤 𝐡𝐞𝐫𝐞 𝐟𝐨𝐫 𝐏𝐃𝐅>> https://lnkd.in/g2TARyT3 #Chromatography data systems help researchers and laboratory professionals with faster, more accurate, and paperless analysis of chromatography data. The increasing need for automation in laboratory instrumentation to reduce manual data entry errors has increased the adoption of chromatography data systems among various sectors. The increasing R&D investments in the pharmaceutical industry increase the commercialization of new drugs. According to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), R&D investments in the pharmaceutical industries in the U.S. and Europe have grown considerably. ➤ 𝗘𝗻𝗱 𝗨𝘀𝗲𝗿 ⇨ Academic and Research Institutes ⇨ #Pharmaceutical and #Biotechnology Industries ⇨ Food and Beverage Industry ⇨ #Environmental Testing   ➤ 𝐑𝐞𝐚𝐝 𝐍𝐞𝐰𝐬 - https://lnkd.in/grPsTFSC #quality #data #food #growth #opportunities #environmental #export #testing #database #datamanagement #biotechnology #foodandbeverage #complexity #healthcare #pharma #healthandwellness #laboratory

‼️ USP General Chapter Prospectus: Process Analytical Technology - Definition, Attributes, Enablers, and Use Cases Posting Date: 29-Mar-2024 Input Deadline: 28-Apr-2024 💠 Background and Objectives The #USP is preparing to introduce a new General Chapter <1037> dedicated to #ProcessAnalyticalTechnology (#PAT). ➡️ The objective is to establish a comprehensive guide that aligns with current scientific and #regulatorystandards, providing clear direction for the implementation of PAT within #pharmaceutical companies. ➡️ This chapter will encapsulate the definition, core attributes, key enablers, and practically applied and modern uses of PAT, with a focus on its timeliness, sampling relevance, regulatory implications, analytical measurement integration, and the production of process- and product-relevant attributes, including #CPPs and #CQAs. 💠 Description of Scope and Application The proposed chapter will provide guidance on the integration of PAT systems within pharmaceutical processes, ensuring that the technology is leveraged effectively for #realtimemonitoring and control, #processvalidation, and #verification, as well as #productqualityassurance and release. ➡️ The scope extends to the use of PAT for process understanding and optimization, including applications in #ContinuousProcessVerification (#CPV) and #RealTimeReleaseTesting (#RTRT). ➡️The chapter will address the regulatory impact of PAT and its role in complying with quality standards. 💠 Preliminary Outline The new USP chapter will contain but not be limited to the following topics: ✅ INTRODUCTION – This section will introduce the concept of PAT and its significance in the pharmaceutical industry. ✅DEFINITION AND CORE ATTRIBUTES OF PAT – A detailed definition of PAT will be provided, along with an exploration of its core attributes. ✅KEY ENABLERS OF PAT – This section will discuss the various enablers that facilitate the effective use of PAT, such as sensors, analyzers, data-driven modelling (including #chemometrics, #machinelearning, and #AI), #processautomation, IT system integration, automated sampling technology, Design of Experiments (#DOE), and risk assessment methodologies like Failure Mode and Effects Analysis (#FMEA). ✅ REGULATORY CONSIDERATIONS – An overview of the regulatory landscape will be presented, highlighting how PAT aligns with current guidelines and standards. ✅ IMPLEMENTATION STRATEGIES – Guidance on implementing robust PAT applications in pharmaceutical manufacturing facilities will be provided. ✅ APPLICATIONS OF PAT – Case studies and examples of PAT applications in continuous process verification, continuous manufacturing, control, validation, quality assurance and RTRT will be presented. ✅ EMERGING TRENDS AND TECHNOLOGIES – The chapter will conclude with a look at emerging trends and technologies in PAT, discussing potential future directions and innovations in the field. If you like this post follow me on LinkedIn

Finally, after at least 20 years of discussions, it seems we are becoming aware that new technologies in microbiology bring many scientific, qualitative, economic and knowledge advantages of production processes. I see that we are starting to be on the right track with new tools that are increasingly being proposed to pharmaceutical companies. I understand that we are entering a very important cultural change, but it had to be done. Regulatory agencies must be at our side supporting and facilitating the adoption of these new technologies. Full speed ahead……………

I have posted a new blog post titled 'How to Communicate in the Pharma R&D Environment.' You can read the full article at https://lnkd.in/gqukns2U and https://lnkd.in/gpEk7YUg. Key takeaways 1. Extended Development Timeline: The pharmaceutical R&D process typically takes 10-15 years from laboratory discovery to regulatory approval. 2. Multidisciplinary Decision-Making: Drug development involves experts from various fields making highly uncertain and political decisions together. 3. Importance of Communication: Effective communication methods are crucial in pharmaceutical R&D as they guide what data needs to be produced, analyzed, understood, and used for subsequent decisions.