 Good morning, good afternoon, or even good evening for some of you. A very warm welcome to our second public webinar, this time on the documentary standards of the USPNF and how to navigate them online. I'm Alex Fichter, part of a great team of USP colleagues operating from the USP office in Basel, Switzerland. We are representing USP in Europe, Middle East and Africa. As one of four strategic customer development managers, as Benoit mentioned in this team, I oversee Central and Eastern Europe and engage with our end users on different USP topics. Well considering the difficulties to travel nowadays and not being able to meet with our customers face-to-face, we decided to innovate our outreach and instead conduct several webinars to at least meet with you virtually. We have lined up several webinars for you with different and recurring topics like this one on the USP online. The next one will be on what you always wanted to know about USP reference standards which will be scheduled for July 22nd. Future webinar topics will be on impurities, performance verification testing, so called PVP, Excipients and USP standards on biologics, just to name a few. So let's begin with today's webinar on documentary standards of the USPNF and how to navigate them online. But before talking or taking you to the topic of standard setting, let me go back in history and introduce USP to you with its long tradition of helping establish the quality and safety of medicines, dietary supplements and foods. It all started with a desperate need for medicine quality before USP was founded. The practice of medicines in the US was very chaotic. There were no uniform standards for quality. Medicines could often be far more dangerous than the cures they were supposed to provide. In 1820, 11 physicians took action to protect patients from poor quality medicines. They founded the first pharmacopoeia of the United States. By the way, the painting to the right is of the old Senate chamber at the US Capitol where they met on January 1st, 1820 to establish the US Pharmacopoeial Convention. From the beginning, USP had an integral part to public health. USP was first recognized in the Drug Inputation Act of 1848, which aimed to stop the uncontrolled flow of pure quality or poor quality and ineffective drugs imported mainly from Europe. Going forward, imported drugs had to meet the standards for strength and purity established in the USP. With the Pure Food and Drug Act from 1906, the FDA was founded as a means to find adulterated and mislabeled food and medicines. The Act also recognized the US Pharmacopoeia and the National Formulary, a separate pharmacopoeia next to the USP, as official compendia under federal law. In 1938, the Congress responded with the Food, Drug and Cosmetic Act to the unfortunate instance where more than 100 people died, poisoned by an antibiotic which had not been tested for toxicity. Companies were now requested to submit the test data to FDA before marketing and this legislation required companies to test new drugs to verify they meet USP's standards for identity, quality, packaging and labeling next to already strength and purity. These are early examples of FDA and USP's collaboration and we continue today to work together as it is essential to ensure appropriate quality standards. USP becomes a vital resource when strategy strikes. Several past crises assented the need for quality standards. In collaboration with FDA and other stakeholders, USP responded with the development of new or to be revised public standards. In 1903, USP introduced the public standard for diphtheria antitoxin to safeguard its manufacture. This was the first ever biologic product monograph admitted into the US pharmacopoeia. Between 1992 and 2007, mass poisoning occurred in Panama, China, Haiti, Bangladesh, Argentina, Nigeria and India because of a toxic dietylene glycol that was used instead of the more expensive non-toxic glycerin in cough, syrups and other medicines. At the request of FDA, USP further revised the monograph for glycerin. At the same time, FDA issued guidance on the testing of glycerin for dietylene glycol. In 2007, a heparin product deliberately tainted with the toxic substance caused the death of nearly 150 people and endured 100 more. The FDA asked USP to change the heparin standard to include testing techniques so that the added substance could be detected. Since then, USP has revised the heparin standard to include other impurities. USP also further refined testing methods for the heparin monographs. I can name more recent ones like the melamine scandal or a meningitis outbreak linked to compounded medicines and even the current nitrosamine issue. Our mission to improve global health through public standards and related programs that help ensure the quality safety and benefits of medicines and foods got nurtured with the lives we helped saving for the past two centuries. Empowering a healthy tomorrow requires a strong foundation. One that establishes quality sets the bar for scientific rigor and technological progress and epitomizes collaboration between industry, non-for-profits, government and academia. So who is USP today? We are a non-profit private independent and self-funded public organization focused on quality standards to protect the public health. We have a global focus and are recognized as pharmacopeia of choice in 150 countries. Our headquarters in Rockwell, near Washington DC is one of our regional bases next to our offices in Hyderabad, Shanghai, Singapore, Basel and Sao Paulo. Some of them also have laboratory facilities to support our collaborative effort in setting public standards and characterizing reference standards. The separately created and funded promoting the quality of medicines plus we call it PQM plus program is operating independently from USP out of offices in Ethiopia, Indonesia and the Philippines and helps improving the access to quality-assured priority medicines in low and middle income countries. More than 1,000 USP employees support the voluntary of roughly 900 scientists, practitioners and regulators to develop the public standards. The USP organizational structure is under a convention. The convention is a membership body that is one of USP3's governing bodies. It includes 492 member organizations from across science and healthcare and from around the globe. Member delegates gather every five years for important governance decisions and throughout the five-year cycle the USP convention works together to advance priority issues that improve public health, patient safety and access to quality medicines. This year's 2020 convention was originally planned as a three-day in-person meeting in Washington DC with programming, speakers, anniversary events and governance activities. As the coronavirus grew more widespread, the convention meeting was transitioned to a virtual event focused on governance activities. As you can see from the very below of this chart the USP staff is there to support all these bodies, the convention members, the expert committees to make sure they are discussing on relevant topics and standards. In the 2020 convention we brought 15 approved resolutions to light which will drive our organization for the next five years and beyond. First and foremost, USP will continue its commitment to collaboration with the US Food and Drug Administration, the FDA, industry and other stakeholders by identifying shared priorities based on scientific principles and leveraging USP's capabilities to help advance patient safety, public health, innovation and access to quality medicines. I could name all the 15 resolutions that are kind of equally important and ways for us to contribute our efforts in the future but I think in the interest of time I will move on. Many of you may ask what is the relationship with FDA since we are a private, non-for-profit organization and independent from government? We established compendial standards that are responsible for the development and revision together with an industry collaboration. We set public standards for identity, strength, quality, purity, packaging and labeling. FDA is enforcing these standards with marketing authorization holders who have approved products to market in the US. Our standards are used by the FDA labs who are frequently testing samples obtained from local pharmacies. However, as you heard before, FDA's engagement with us and stakeholders goes beyond enforcing our standards. As we estimate our standards to impact around 2 billion people globally, we believe that USP standards play a very important role by expanding access to medicines of good quality. Those standards are developed in collaboration with all stakeholders, government, industry and scientists. Standards are even more important in the context of global supply chain. Standards are also used to combat counterfeit drugs. USP plays a critical role in the trust a patient may have when taking the medicines. Both patients and practitioners assume that the drugs are safe efficacious and have the correct identity. Deliver the same performance as described in the label. Perform consistently over their shelf life are made in a manner that ensures quality. And, last but not least, will be available when needed. Adonis duration is a legal term, meaning that product fails to meet the legal standards. In the Federal Food Drug and Cosmetic Act of 1938, one can read that a drug product in the US market must conform to the standards in USPNF to avoid possible charges of adulteration and misbranding. The supply chain of the component of a medicine became extremely complex during last decades. Our standards help detect adulteration, especially during crisis time. A substandard medicine may contain no active ingredients, less than required amount or too much of the required amount. It may also contain ingredients not described on the packaging label. Quality can deteriorate in many settings, for example during manufacturing, packaging, distribution and storage. This is especially true in developing countries where supply chains are long and fragmented. Compliance with USP standards help assure that patients receive quality medicines. A very poor part, falsified medicines, they are intentionally sold to unsuspecting patients for profit. Like substandard medicines, they may contain no active ingredients, less than the required amount of active ingredients or too much of the active ingredients, or even ingredients not described on the package label. In just one year, a projected 122,000 children under the age of five from 39 sub-Saharan African countries lost their lives as a result of quantified anti-malarial drugs alone. USP works with local regulators around the world to develop the capacity to detect and remove falsified and substandard medicines from the market. And in all fairness to say, indirectly, with the support of USP, with the order of reference standards in our publications, you are indirectly supporting this horrible and intentionally sold to unsuspected patients processed by companies who are only in for their profit. According to the review of antimicrobial resistance, roughly 700,000 people die each year due to drug resistance and illness such as bacterial infections, malaria, HIV-AIDS, or tuberculosis. We know that substandard and falsified medicines can contribute to multi-drug resistant strains. Quality standards of pharmacopias around the world help ensure the identity, strength, quality, and purity of medicines. They provide a measure to which to test and thus they reduce AMR by helping keep subcontinent medicines out of the market. This objective can be further advanced by enhancing the capacity of regulatory authorities and manufacturers, especially in low and middle income countries. The goal there is to help ensure safe and beneficial medicines, including antibiotics so that substandard and falsified products are detected. Let me now walk you through the documentary standard setting process with USP, which I believe is similar to other pharmacopias. We trust in partnerships and work with experts in health and science across industry, nonprofits, government, and academia to develop public standards, monographs, and reference standards that are critical in helping ensure quality medicines, dietary supplements, and food ingredients. USP monographs include the name of the ingredient or preparation, the definition, the packaging information, storage, and labeling requirements, and of course, guidances. Within those monographs, you read specifications according to your trust protocols that you are familiar with. Those specifications consist of series of tests, procedures for the tests and acceptance criteria. These tests and procedures require the use of official USP reference standards. And a single monograph may include several different tests, procedures, and or acceptance criteria that reflect the attributes, the quality attributes of different manufacturers, substances, and products approved in the United States market. For the monograph development process, we recognize two different processes. One is to keep already existing monographs up to date by a modernization product that help ensure the methods in the USP reflect those that industry currently uses. And we're constantly seeking for support with new monographs that become essential as a public standard as soon a patent of a drug product is distinct. We have a priority new monograph list on our website, and we encourage you to check these lists if you are a sponsor seeking to aid in developing monographs that are not currently part of the official USPNF. USPNF general chapters describe the detailed tests and procedures referred to in multiple monographs. So they are referenced there in these descriptions of tests and procedures for application through individual monographs. You find descriptions and specifications of conditions in general chapters, as well as practices for pharmaceutical compounding. You find general information for the interpretation of compendial requirements, descriptions of general pharmaceutical storage, dispensing, and packaging practices, or general guidances for manufacturers of official substances or official products. Each of these general chapters is assigned a number that appears in angle brackets. For example, the chromatography chapter that has the HPLC part in there, for example, is called 621. We often refer to 621 when we talk about HPLC topics, for example. Important to mention here is that 621 is a sub-thousand chapter which is enforceable because it is referenced in either one or more of the monographs. General chapters numbered above-thousand are informational only. They are guidances, as mentioned before, interpretations of compendial requirements, descriptions of general pharmaceutical storage and dispensing. Essential to read at least once are the general notices. They are often forgotten to be the overall guiding principles for using the monographs and general chapters. They provide clarity for basic assumptions, definitions, and default conditions for the interpretation and application of the USP and DNF. We really encourage you to look up general notices, as I said, at least once, so you are aware where to find what. In a situation, you are reading a text in the USP-NF and you need further guidance, clarity, definitions, or whatsoever. As you can see from this flow chart, the development of monographs and reference standards is working in parallel. Let's stick with the monograph development for the sake of this presentation. Analytical methods and supporting documents are sponsored by the industry in most cases. They provide us with the analytical portion of the dossier, submit to the FDA for approval. We work with innovators, engineering manufacturers, and select those methods that are most up-to-date for the development of a monograph. The timing of the collaboration most often depends on the patent situation of each drug. Five years prior to patent expiry, we reach out to the innovator and request their support. Depending their post-patent strategy of the particular drug they decide, at which point within those five years, they want to collaborate with us. In the meantime, generic manufacturers emerge with their submission for approval to FDA version of this drug. Their analytical methods often represent a more current industry standard with specifications and acceptance criteria as good as the innovator drug. At the end, we are responsible to select the best methods, regardless of the source. The analytical methods and supporting documents are evaluated by our scientific liaison, and if complete and scientific sound, they are formatted as specifications into the monograph style and shared as a first draft with the sponsor before publishing the proposal in the Pharmacopil forum for public review. The Pharmacopil forum will be in one of the next slides explained. It's basically a public free-of-charge platform for those people that are in a surveillance program to constantly review news and novelties that are proposed to the USPNF. Within that public review, the comments that we received during 90 days will be discussed with the expert committee. They approved the monograph for adoption into the USPNF if no major concern was raised during the Pharmacopil forum phase. Standards that are published in the USPNF receive an implementation period of six months. Let's go into the USPNF online tutorial. You can also start your journey to access the USPNF online from the website dedicated for the USPNF only. In here, you find all relevant information to the US Pharmacopeia. It also helps you navigate back to the USPNF website featuring compendial tools that may help with your daily analytical requests. We won't go there as a tutorial through the website could fill easily the content of another webinar like this. You also find FAQs on the USPNF website. It really helps you in gathering the whole information around the USPNF, its use and its establishment. Once you logged into the USPNF online with your access point credentials, you'll see this start layout. A good advice if you are not familiar with the website is to tap the start here button for analytical advice where to find what. If you are responsible as mentioned to frequently survey changes occurring in the Pharmacopeias and simply want to get a short glimpse of what has changed against the previous version, please also tap the start here button. On the top right, you see a label for welcome Benoit. Benoit is one of our user personas. When you click on this area, you can manage your own account for the USPNF online. So when you log in, obviously your name will appear up there. This page shows a search box at the top that's present on every page. So you can always conduct the search no matter what page you are on. The USPNF online dashboard is a learning platform where USP provides tips and tutorials to help users quickly get up to speed on the new system. And below that section, you see an icon that clearly indicates which version of the USPNF you are viewing. And that is the official version. At the bottom are two tabs. One tab shows the most recent 20 page as user that the user has visited, making it easy to go back to any recently viewed page. The content of this tab is automatically generated by the system. The other tab shows the user's bookmarks. These are pages specifically saved by the user. The new search function provides autocomplete and autosuggested functions. Results are sorted into categories, such as monographs and general chapters. Ends display on the drop-down list as you type. And here, using a Citroen MyScene as an example, 13 results will appear. On the monographs, you would have five results where our Citroen MyScene would appear in the channel test and assays, and you have further four results related to front-matter issues. Once you hit enter to complete the search, in this case, Citroen MyScene, the results are displayed on the page as shown. Each document clearly indicates its dates and when it was published. A collection of filters on the left side allow you to narrow the search results according to a variety of criteria. These filters operate like the category filters on Amazon or other websites. The icon keys for currently official, not yet official, and no longer official are further explained in the help section under icon key. Let's hit the AzoA Citroen MyScene monograph. The example of this monograph is displayed here. It is blue underlined just to show you where a Citroen MyScene as word is appearing everywhere in the whole text. And I wanted to point out that although the new design of the system looks very different from the old USPNF, there have been no changes made to the content of the monographs or chapters other than the regular update process that occurs each year. The changes you see are in the way the information is displayed, but not in the information itself. Those of you who are completely new to the USPNF might not know that the layout and the platform has changed three years ago. So this is what you see here. And again no changes have been made to the content of the monographs and the chapters from the previous platform to the new layout as we are giving you examples here. The green bar indicates that you are looking at the currently official version of that monograph. You can view newer or older versions by switching to the documents available on the document tool sections. Note that for each monograph not only you can create a bookmark, but also an alert so you can be notified of changes to that document. There are a couple of important information that we need to mention. Information on referencing guidelines for document citations are part of the FAQ and can be rewrote there. With the new platform, USB is introducing a more document-centric model for the version control and presentation of our documentary standards. If those of you who remember the previous platform they made citations to monographs based on the page where this monograph was displayed in the USPNF. Not only have we no longer printed versions of the USPNF available, moreover this new document-centric model for the version control becomes essential for the reporting of your process. Important to mention is that whether a document is official or non-official it will no longer be linked to when a specific publication such as the main USPNF edition or one of the supplements become official, but instead to status of the individual document. Each individual document within the new online publication has its own official date of reference which is linked to a unique permanent documentary identifier, the unique DOC ID which is available in the new USPNF online platform under auxiliary information at the complete bottom of a monograph. The unique DOC ID will only change when there is a revision to the document. The unique DOC ID do not change with each publication. This is the DOC ID I was referring to. In the Acetromycin monograph under complete button when you scroll down of this monograph you find under auxiliary information several information not only who is the scientific liaison responsible for this particular monograph and what expert committee is supporting. You find other supporting information such as where to go when you need the column information that is not displayed in the monograph as you may wish if you need to search for a column that is maybe not any more available for an analytical purpose, but you find at blue underlined at the very low bottom what we already mentioned just previously the current DOC ID which is unfortunately a very long number but be sure this number will not change except for the last digit which in this case is a 5 and if the document has not changed to a more current version the document ID for this particular monograph will remain to be the last issue of this DOC ID number 5. It will subsequently change to 6, 7, 8 or 9 once the document is changing. For general references in your documents test procedures and dossiers USP recommends using the name title of the monograph for general chapter such a general reference is understood to refer to the currently official version of that standard and maybe appropriate in certain circumstances. Each SOPs as I mentioned policy documents anything you need to have on a regular surveillance where it would be difficult or unnecessary to update the specific version of a standard to reflect each subsequent revision. For specific references USP recommends using the unique DOC ID that we just have shown you which appears under auxiliary information. If you need more information on how to reference this DOC ID best you can visit again the uspnf.com website on the frequently asked questions will refer to this topic again. This is what I promised you and now moving away from the USPNF online I think as a tutorial itself this could go far more beyond of the contents of just this webinar so if you are interested to learn more about the USPNF you can always visit our website for other events related to just this topic. We also offer courses on the use of the USPNF online especially if you are new to the topic but as promised before the Pharmacopial Forum that is featuring all the proposed documents that are drafted to form either a new monograph general chapter or are drafted to propose a revision of an already existing monograph or a general chapter to become up to date is the platform that you can freely access it's available since about two years under this new platform there is also a legacy platform for previously proposed Pharmacopial Forum issues every two months we publish new proposals your collaboration is vital to the setting of quality standard and I encourage you to frequently visit this page having been through the documentary standard setting process and a short USPNF online tutorial I would like to now go into some of the areas of the usp.org website that provide additional resources for your use we have there an overview of usp education programs it is fair to say that we're very proud of having already more than 50 000 students trained on various topics of the USP since 2000 we're covering many quality topics in our educational program such as courses for draw products and API biologics general notices and so forth those courses are created by the very scientists who develop the USP standards and collaboration with our scientific liaison who is at the forefront of all knowledge and information regarding the general chapter our usp education department is creating the content which is constantly updated to its current nature we provide classroom education courses usually but obviously given the times in the situation right now we have moved over to a more virtual way of providing course content to our end users we would also in the normal situation be able to provide laboratory practice sessions what we do like you know now our life life web webcasts webinars but you also can order training programs that are self-paced and you can learn on the way you go our usp website is providing you more information on who we are what global impact we have and what we work on our products and services our events that we constantly offer and how you could personally get involved in the standard setting process we have created a reference standard app especially for those who are maintaining internal stock of reference standards it's a very very easy tool that help comply with usp reference standards you receive notification through this app when a specific reference standard is updated you can alert yourself for new reference standards when available you can set bookmarks to reference standards particularly interested to you and it also has a barcode scanning mechanism which is easy to check on the valid use date for your reference standard on stock usb offers a range of information education videos and compliance videos on the value beyond the vial customer development management and development process education and scientific liaisons we have educational videos as well on performance verification testing the solution courses how to effectively for example the gas media essential for the pbt test you can find videos on partnering with usp contribute to our standards and help develop reference standard material our four main email addresses starting with customer service obviously where you can order reference standard or send in your queries reference standard technical support is managed by Lisa Corbin she wants you to send in your requests to a generic version of her email address which is rstec at usb.org simply for the reason for her to manage all incoming queries eventual complaints notifications in one system so he can manage so she can manage this on their part more effectively the same applies for usp the api and drop product monographs of which requests should be sent in to stds monographs at usp.org ryan gilbert is the persona behind this support whereas robert laugh aware is supporting national formulary part excipient monographs dietary supplements internal chapters under NF monographs at usp.org and by the way i've been always referring to usp and usp and f you saw a little bit of history in the beginning you saw that usp and nf was actually were actually two different pharma copias independent from each other we merged in the 70s to one pharma copia we called ourselves the usp and f ever since the usp part of the usp and f have become the api and drop product monograph sections to get over general chapters and the general notices whereas nf the national formulary part featuring excipient monographs dietary supplements and of course general chapters as well so with this i'm thanking you for your attention i hope it was informational to you and i would suggest that we do now a quick poll of three questions just for us to understand how much of the deliberate content of this webinar was understood and where we eventually could do some improvements thank you very much alex yes indeed it was very clear and a very comprehensive presentation thank you so much you did a great job welcome thank you as alex mentioned we are now proceeding to the poll um you have now on your screen three different questions i will read them and again i repeat myself those and your answers will remain anonymous so feel free to answer even if you are not 100 percent sure the first question is usp has access to nda and a nda findings to help establish the monograph is it false or is it true usp has access to nda and a nda findings to help establish the monograph the second question is only the innovator can sponsor a monograph of an ingredient or finished dosage form is it false or is it true third question is usp and online is the only official format please answer to those questions usp has access to nda and and the findings to help establish the monograph only the innovator can sponsor a monograph of an ingredient or finished dosage form usp and online is the only official format don't forget to click on submit once you have answered those questions christian christian where are we now yeah we have 52 percent of the participants um okay submitted the poll finished the poll there are 10 more percent in in progress and i think we can probably close it now to to show the results it's running already for two minutes please also put your questions if you have one or two in the question and answers field so that we can respond to to that right now here so i'm closing now the poll and we should have it now so we have poll results shown here benoit okay so i repeat the first question usp has access to nda and a nda findings to help establish the monograph well if i read the results i see kind of i mean half half answering forth and true um well actually this is false usp develops standards based on data that are submitted by market authorization holders who receive nda or nda from fd those data are private that they belong to the market authorization holders fd has not the right to disclose confidential information proprietary information to usp so the only source for usp is actually the market authorization holder itself so the answer to this question is actually folks the second question only the innovator can sponsor a monograph of an ingredient or finish dosage form this is uh false the correct answer is false which represent majority of the answers we receive that's right a monograph can be sponsored by a generic manufacturer as well as long as an nda was granted so the source of the monograph is coming either from innovator or from a generic manufacturer again as long as the market authorization nda or a nda was granted the third question usp and f online is the only official format here the correct answer is actually true but let me explain you a little bit further it is true as of 2020 print and usb formats will be discontinued only the changes and revision of the previous year will be published as a book so if you want to have the whole content of official documents only one source is available this is the usp and f online and this since 2020 this year thank you very much for your answers and i think it is now time to to move to the question and answer session so please ask your question use the the chat system so that we can get your questions christianne i don't see the questions okay you don't see it right um i can i can i can um yeah i can ask some questions so um the first first question um that came up is um do we record the webinar and do we make it available later or can we share the slides um alex benoit do you want to answer shall i answer i can um we're not allowed to share the slides but we are um recording these webinars and we will put those recordings at a website at some point which we probably will disclose soon after this webinar the platform is not yet on the percent sure it could be you too or it could be facebook um depending on the opportunities that we have but those who have already participated and also registered to the webinar will be notified at the location of these recorded webinars okay thank you alex there's another question please can you tell us about which parts and sections of the monograph um of a drug substance drug product monograph is legally binding for a drug product manufacturer but legally binding is first of all only for those who are marketing their products in the united states have approved drug products in the united states so the parts of the monographs are legally binding in the sense that they are enforceable it is a compliance standard that we publish meaning that um you can ensure yourself that if and when you test your product for the quality attributes written in the usp nf you will pass in all fairness to say nobody really is taking the risk if marketing to the united states so they test each and every batch that is released to the us market under the quality attributes has outlined in the usp nf so the monograph specifications are legally binding within the monographs as mentioned general chapters are appearing as general test procedures to fulfill the analytical test procedures accordingly if mentioned in the monograph a general chapter is legally binding as well okay thank you very much i see another question can you visit us right now or can we meet virtually maybe well i can take this one of course visiting you is definitely something we would like to do of course but as you know travel restrictions apply and it would be very difficult for us to it is very difficult for us to travel nowadays this is what we do usually but not anymore right now can we meet virtually maybe yes of course so if you want to have a discussion with us a virtual discussion on the web you may reach out to us and we can organize definitely a virtual meeting to assist you further i can only second that comment then we would really love to engage with you over the means we have right now being in the vebex telephone email just reach out to us another question is what are the page information on top of unique document id if you read the indeed if you remember the slide from alex alex uh on above the document id itself you have the page information as we said in as alex said in the past we were referring the page number of a specific document and the for instance uh usb 41 nf 36 the azithromycin monograph was on page for 20 we no longer do that because we are moving away from the format over the print format version um but this is related to the old print that we were releasing in the past yeah we have another question here on the in the question and answers box um if you want to obtain a chapter like for example gender chapter 661 from usb do you need to um to buy the full nf subscription upon appeared also obtained as a standalone document no please um we are working on a more modular platform of the usp nf where only single areas of the usp nf can be accessed to if you don't need the whole content of the usp nf but that's future right now you can ask a single document for purchase which will then be a pdf created and available for you to download it would have to go either through us first or directly to customer service to mention the specific document that you would like to order and then they they'll give you a price i'm not i'm not any more sure because i did not follow in the past such requests but i think a document to process through customer service a pdf that has been sent to you isn't the area between 100 and 150 euros so if you consider the whole documents to cost 700 dollars for a single access license i mean you do the math how economically this is depending on how many more single documents you would want to obtain over the time and i would add what to what alex said that if you get a single document like a general chapter it is you get the document but it is out of the environment itself so you miss all the other information such as general chapters the monograph and so on so i mean it's it's your call of course but this is not something i would recommend especially as the difference between the the the the especially as the difference between the price of the single document and the price of the whole usp and f the difference is not that big so i mean it's it's your decision of course another question that i received which is a quite an interesting one what if a monograph states a reference standard that is not available um first of all a reference standard may not be available because it has never been released by usp so there is no entry of this specific reference standard in the usp catalog that is very rare but if that is a case the procedure calling out for this specific reference standard is not official until the reference standard is made available in the usp catalog now if it is a reference standard that exists in the catalog but is currently not available it's on backorder then the situation is different the procedure remains official any other question yes we have one more question yeah we have one more questions here one more question here if if there are concerns with any of the usp monographs methods the analytical methods there then what is the procedure how we can can get in contact with usp what is the procedure there so depending it is a nf or a usp monograph or even a general chapter um you probably remember those email addresses i have given you they are the first line of technical support meaning that they can address your concern with suggestions on how to improve the situation the analytical situation in using this monograph or general chapter in your laboratory if you end up you know confirming together with our technical support that in fact there is an issue with the analytical procedure then you could initiate a revision with the usp nf which would ask you to submit the scientific basis for your concern which is a procedure that is described as well on our website if you need further information again please reach out to us individually yeah and maybe also good to know for for the users that a scientific liaison is always mentioned at the end of the documentary standard um in the online version well also also in the print but it can be contacted um the person can be contacted um very easily also um from the online version there's directly the the contact mentioned at each end of the documentary standard monographs or general chapters yeah i think i received a question a private question actually um which is a lot more a comment than a question or a suggestion let's say can we have a catalog details of impurities separately as some customers are requesting for it um right now our catalog encompass everything the impurities together with apis and excipients and so on i take it as a suggestion uh but for now there is no separate catalog we have also some questions here that are all um referring to um to harmonization um maybe we can can give a quick update on on harmonization here as well or how we harmonize um how we harmonize monographs and and general chapters to to a certain extent okay i can take this one um there are two types of harmonization the retrospective harmonization and the prospective harmonization the retrospective harmonization is about harmonizing documents that are that exist already uh in the late 80s i think it was in 1989 the three main pharmacopeias at that time the jp the ep and the usp they created a group called the pharmacopeia discussion discussion group the pdg the goal of the pdg is to harmonize existing monographs or retrospective harmonization and they decided to harmonize um let's say uh uh broad impact documents so there in the scope of the pdg they selected um roughly you can remember well close to 70 excipient monographs which are broadly used so the best sellers as well as a certain number of general chapters because if you want to harmonize an excipient monograph you need also to harmonize the corresponding procedures um on top of that um ich told the pdg to harmonize additional general chapters like microbiology or dissolution so the pdg is working on harmonization of those excipients and general chapters the process is fairly long fairly slow it's a steady process though but right now i think we have more or less uh harmonize the majority of the general chapters and we have still uh another i think uh 10 or 15 monograph for excipients to harmonize i remember uh in the past uh alex and alex we remember as well we used to have a very good colleague terry way who was uh always uh mentioning a joke about that and the joke is the following you have three people sitting around the table talking about harmonization of the monograph and each of them saying harmonization very easy so long you do it my way so that means that um harmonization is a difficult exercise there are a lot of hurdles a lot of barriers and uh it's not just about regulatory environment uh legal environment but it's also about scientific judgment and expertise so this is what we do on harmonization uh on retrospective harmonization with uh through the pdg and again uh it is a part of the resolution of the usp to work on harmonization the second process for harmonization is uh called the prospective harmonization this is a different process because here um there is no existing monograph in either for instance e p and and usp and a sponsor market authorization holder might want to uh submit the data to both e p and usp as long as we end up with a monograph that will be harmonized at the end so it's called prospective harmonization this is not a formal process like the pdg process this is a more an informal process we are working on this time we work on api harmonization api prospective harmonization and we were fairly successful uh i don't know exactly how many monograph we harmonize this way but i think we are close to 50 monograph we do the same as well with uh the the british pharmacopeia who is uh uh developing standards for finished dosage forms so we work with e p from api and with vp for a dosage form i don't think that the jp is part of this process i don't think i have not heard about that but i don't think they are part of that yeah i can confirm they are not yeah how about harmonization with chinese pharmacopeia any plan for this um well i i don't know all the details but um there is no uh specific there is no real collaboration with uh the chinese pharmacopeia and the usp on uh specific harmonization what i can say is that uh every year there is a kind of uh congress or a symposium i don't know exactly that gather all the pharmacopeia of the world and i think they are around uh 30 different pharmacopeias and they discuss about the process to develop and establish standards and the the purpose i think is to uh set up what we what they call good pharmacopeal practices good pharmacopeal practices aim to have a more harmonized process to develop standards i'm not 200 sure about that if alex and and question do you have any additional comments on this uh topic a lot on my side no me me neither no yeah so we have a few more questions yeah there are a few more other questions but i would say we should discuss those uh offline and send to the users directly they are very special questions um that are right now somewhat difficult to um to reply to yeah wasn't there one on pending monographs maybe that one quickly we can take yeah go ahead where do you see that yeah please please do i that was that was a question quickly appearing uh somewhere maybe it was even in my personal private uh chat but i i don't have that open so everyone who wanted to discuss with me privately i'm sorry i haven't seen that it was just a question shortly appearing and i think it was related to what's the meaning of pending monograph and i think and i think this was seen when we had the slide of the usp and f website where there was specific section of pending monographs pending monographs are monographs that we have developed together with a sponsor uh of analytical methods and supporting documents a sponsor who has not yet received approval to market its rock product in the united states they are still in process meaning pending to receive fda's approval um our guidance and policies allow the collaboration with an industry partner so-called sponsor as soon as they have sent in their application to the fda and whatever present as analytical method at that time will be used to develop the monograph the monograph will separately be approved by our expert committee and sits there as an already by expert committee approved monograph until the drug product is approved by the fda the risk always could be that fda is requesting more data or to change certain data that are part of the data package submit to usp so the risk could be that some changes would need to be made once the approval of the fda has been given to the drug product if there are no changes to the document package these pending monographs yet approved already by the expert committee don't have to go through a public process again meaning through the pharma could be on forum as soon as the drug product is approved by the fda these pending monographs are being published to the usp and f and begin to be official again with a six month implementation period i hope that answers the question i don't see any other question do you yeah as i said there are a few but they are um very special and we should yeah we can take them offline that's fine offline yeah yeah so thank you everybody thanks for attending this meeting it was really great having an opportunity to speak to you via this way i think ben why is taking it from here yes uh thank you for the great session and the great presentation i like say it was a wonderful job and we received quite a few questions and we could engage with our customers but of course as we said already we can engage with customers even further through private discussions and webinars we can meet virtually so alex christian myself we do remain at your disposal should you have any anything to discuss with us further so with this i think it's time to conclude this presentation thank you very much everyone for your attendance i hope you enjoyed i hope you got valuable information and again thank you alex for your presentation you're absolutely welcome thank you very much for moderating and keeping everything in shape by the way christian syna who is in the background i'm not sure i was not following correctly your introduction but no i'm not sure whether he was introduced christian syna is our head scientific affairs at usp office in basal and he is supporting us and industry on scientific and technical matters thanks also christian to support this session and by the way the next webinar will be held by christian himself so there you get a fair opportunity to be introduced to him a little more personally so thanks everyone and goodbye thank you thank you goodbye thank you bye bye bye