United States Pharmacopeia Standard R&D and Technical Service (Shanghai) Co., Ltd.

https://store.usp.org/excipients/category/USP-1002

We are continuing to get to know the people working day-to-day behind the pharma companies shaping the industry, the ones who keep the wheels turning and ultimately bring better healthcare to the population; we are talking to the individuals at the heart of pharma.

This handout highlights how the USP Ingredient Verification Program helps ensure the quality of active pharmaceutical ingredients (APIs).

On the 7–9 May 2024 in Philadelphia, CPHI NA will be presenting an unmissable agenda, filled with content across 4 main tracks. In the following interview the Supply Chain Economy Track sponsor, the US Pharmcopeia introduces the track, and what they're most looking forward to. 

The USP Ingredient Verification Program helps ensure the quality of excipients by:
- Auditing manufacturing sites for conformance with Current Good Manufacturing Practices (CGMP)
- Testing product samples in laboratories
- Reviewing quality control and manufacturing product documentation
-Monitoring annually with CGMP audits, product reports, and product testing

In our packed out content sessions at CPHI Barcelona this year we focus on some of the hottest topics coming up in the pharma industry, with each track sponsored by a leading expert in the field. 

USP Global Health programs work to strengthen regional and local manufacturing capacity of medicines, vaccines, personal protective equipment, medical devices, and other health products to provide more equitable access for patients and communities worldwide.

www.usp.org/global-public-health/building-manufacturing-capacity

USP’s Analytical Lab Services support implementation of flow chemistry and continuous processing from R&D through manufacturing to drive innovation, contain costs, and optimize efficiencies in staff and resources. Our solutions are tailored to your unique needs and ensure the quality of your advanced manufacturing methods through​ rigorous scientific expertise, dedication to quality standards, and adherence to best practices.

http://go.usp.org./analytical-lab-services
 

The USP Dietary Ingredient Verification Program helps ensure the quality of dietary ingredients, in addition to supporting the qualification of suppliers

How contributing benefits you 

Your contributions improve the quality of  products worldwide—USP standards are  used in more than 140 countries. 
• Reduce the flow of adulterated or substandard articles, ingredients and products.
• Maintain regulatory compliance.• Contributions may be tax deductible.

USP Proficiency Testing Program is USP’s latest evolution of our commitment to quality. The accuracy of laboratory test results depends on the skill of its staff, the equipment and processes it uses, and its systems for controlling quality. Our Proficiency Testing schemes use USP’s trusted methods and General Chapters, providing an objective assessment of staff competencies, specimen handling, equipment functionality, and results reporting. Participating in our PT program will also help to meet the ISO and regulatory requirements. We offer a wide range of testing schemes in areas such as pharmaceuticals, microbiology, biologics, and supplements in both scheduled and on-demand format. No matter what your goal is, USP PT has the solution for you!

USP’s Analytical Lab Services support implementation of flow chemistry and continuous processing from R&D through manufacturing to drive innovation, contain costs, and optimize efficiencies in staff and resources. Our solutions are tailored to your unique needs and ensure the quality of your advanced manufacturing methods through​ rigorous scientific expertise, dedication to quality standards, and adherence to best practices.

http://go.usp.org./analytical-lab-services
 

Dissolution Performance Verification Standard (DPVS) - Prednisone tablets have been developed to create greater reassurance in the performance qualification of Dissolution Apparatus 1 and Dissolution Apparatus 2. This will be the official standard for PVT when the proposed revision for USP General Chapter <711> Dissolution becomes official

To safeguard patient and practitioner trust in medicines, manufacturers must ensure that impurities in their drug products and their ingredients are properly controlled regardless of who makes them and how they are produced.

Thus, impurity analysis and profiling are critical during drug development and throughout the product life cycle.


Our new suite of Pharmaceutical Analytical Impurities, together a comprehensive solution to your research and analytical needs.

This handout highlights how the USP Dietary Supplement Verification Program builds trust in the quality of supplement products.

Join us as our experts delve into the current state of pharmaceutical manufacturing on American soil, examining the drivers, challenges, and outcomes of the onshoring trend within the US pharma industry. In this session you will: Examine case studies and success stories that highlight the progress and challenges in realizing onshoring goals within the US pharma market Analyze the impact of regulatory changes and supply chain disruptions on onshoring efforts Assess hybrid Onshoring and Nearshoring

Join us as our experts delve into the current state of pharmaceutical manufacturing on American soil, examining the drivers, challenges, and outcomes of the onshoring trend within the US pharma industry Examining case studies and success stories that highlight the progress and challenges in realizing onshoring goals within the US pharma market Analyzing the impact of regulatory changes and supply chain disruptions on onshoring efforts Assessing hybrid Onshoring and Nearshoring

Reviewing the outcome of the inflation reduction act and how it is affecting pharmaceutical manufacturers and distributors in managing drug pricing within the supply chain, including:
Examining broader economic and market trends influencing drug pricing within the supply chain economy and their effects across US Healthcare

Leveraging Data Analytics for Build a More Resilient Supply Chain. Today, patients in the United States and around the world depend on medicines—and the ingredients used to make those medicines—sourced from and manufactured around the globe. The recent pandemic, geopolitical, and natural events have not only led to medicine shortages but have also exposed systemic pharmaceutical supply chain vulnerabilities. Understanding and addressing these vulnerabilities require a systematic approach to building a more resilient supply chain: Understanding supply chain challenges Implementing solutions to supply chain challenges Detect problems and predict risk through data analytics Provide recommendations to address and alleviate the risks Solve problems through advanced manufacturing technologies Scale solutions through collaborative partnerships

Data analytics is playing an increasingly important role in helping companies achieve supply chain excellence. By collecting and analyzing data, companies can gain insights into their supply chains that can help them improve efficiency, reduce costs, and improve customer service How Data analytics can be used to track and trace shipments, identify bottlenecks, and optimize inventory levels Data analytics can also be used to predict demand, forecast future trends, and identify risks By using data analytics, companies can make better decisions about their supply chains, which can lead to improved efficiency, reduced costs, and improved customer service

The story of how patient advocacy, patient centric design, and partnership is rebuilding the global pharmecutical supply chain to ensure access to all.

Technology is playing an ever-greater role in life sciences, and new ways of working in automation and supply chain. Join our panel of experts where they will delve into what is required in developing a new standard for manufacturing quality Focus on business and patient outcomes over technology to help identify the right setup Making your data actionable to improve decision-making and real-world automation Identifying the right Enterprise Resource Planning system for your supply chain and manufacturing process Establishing measurable KPIs to better manage and evolve your supplier network based on qualitative and quantitative factors

The ACS Green Chemistry Institute (GCI) and the pharmaceutical industry are collaborating to advance and facilitate the implementation of research, development, and commercialisation of greener chemistries for a more sustainable pharma industry.
To catalyse tangible green and sustainable chemistry and engineering innovation, the member companies of the ACS Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR) have identified, designed, and deeply examined a unique toolbox that includes an array of commonly agreed-upon metrics and tools, widely used by the industry while designing their processes. This session is cover the following: Developing effective accessible tools, including Reagent Guides, an interactive solvent selection tool, a calculator for comparing the environmental impact of analytical methods Assessing current benchmarks of pharmaceutical processes as well as a preview of new tools currently in development

Continuous manufacturing offers flexibility in scaling up or down production, resulting in improved supply chain management and reduced drug shortages. Join us to learn how continuous manufacturing can be enhanced with the implementation of advanced systems and integrating real-time analytics to improving overall quality. How continuous manufacturing and Process Analytical Technology enhance quality and process understanding Best practice in setting up continuous manufacturing production lines

Most pharmaceutical companies are slowly adopting an electronic method to manage the quality of operational processes and organisational priorities across the value chain. Join us and hear from our expert on how to maximise automation systems in your supply chain. Obtain the quality information you need to discover failures early, and rapidly adjust your production process when needed Automate quality control to process a high volume of samples and reduce human error

Understanding the impact of ingredient quality on pharmaceutical companies of all sizes is essential. Join this presentation to dive deeper into ingredient quality trends and solutions available to minimize risk. This presentation will address: Potential impact to pharmaceutical companies concerning recent regulatory trends relating to ingredient quality Supplier qualification process examples at pharmaceutical companies Tools that can assist small and large pharmaceutical companies with reducing supply chain risk and disruptions due to ingredient quality

We have created an information hub on novel excipients. We welcome you to scan the QR code and visit it. When you are there, please share with us your top challenges in developing or using novel excipients and you’d like USP to help. Your inputs will help us structure other platforms to discuss this topic. In the hub, you can learn about our emerging standards approach and its applicability to setting standards for novel excipients.