How to create a powerful unique selling proposition usp. Sutton1 and david porter2 as good manufacturing practices gmps became a governing principal in pharmaceutical manufacturing, the purpose 1alcon laboratories, fort worth, tx and 2u. The new usp general chapters usp elemental impurities. Usp test chapters, which contain validated methods and associated reference standards, can be particularly helpful to test for and control quality at any stage in the product life cycle. Must not include a common word or commonly used sequence of characters. The tests for specified microorganisms are included in usp, the modifications change many microbiological medias utilized in testing for specific pathogens. Test chapters facilitate method adoption following verification that it is suitable for a new application.
How to write a million dollar unique selling proposition usp, upword your marketing message. Known limitations with usp chapter heavy metals, which was written in 1905, have led to the development of new methods for the preparation and analysis of pharmaceutical samples. For further information and support please go to the website of the issuing pharmacopoeia. The calculation allows you to determine the balance measurement uncertainty of the balance and by using a correlation curve this can then help you to determine to minimum weight which can be accurately measured on a balance. Patent and trademark office to select the denver metro area for its next satellite office. However, the standard does allow for configurations that combine. The passing of dan kennedy joe vitale of the secret dvd. Also, how you can develop your usp to reach out telepathically into the minds of your customers and just like in the movie inception and give em an idea that they think is theirs. His classic book the ultimate marketing plan promises lowcost ideas and. Usp packaging storage and distribution expert committee. Middle east, and in the indian subcontinent, have been per sistent and patient despite criticism from both.
Antimicrobial preservatives are substances added to nonsterile dosage forms to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent to the manufacturing process. Usp is meant for therapeutic protein injections, making changes for smaller test product volumes and smaller test aliquots. Balances ira 1jul2014 is virtu ally independent of. The u ni te d s ta te s p ha r m a c o pe i a i s the c o o r di na ti ng pha r m a c o pe i a. Usp microbiological control of aseptic processing environments and its implications source. The plan he presents is carefully created and based on his own experience in the field of marketing and sales, which reinforce the plans credibility. Interested parties may submit comments by mail or commercial carrier by august 15 to. Usp chapters and implementation strategy kahkashan zaidi usp. Those that must be sterilized before administration. Historic geographic and seasonal trends may be used as a planning tool in selecting among the types of temperature and humidity monitoring devices. Kennedy was evenwel een meer pragmatisch dan ideologisch geinspireerd leider. He knows exactly how to deliver a marketing message with maximum clarity and zero confusion. The usp, in parallel with the international council for harmonisation of technical requirements for pharmaceuticals for human use ich, has published new standards for measuring inorganic impurities in pharmaceuticals and their ingredients. Standardization of ph meter standardize a ph meter using the 0.
Dan kennedy wealth attraction for entrepreneurs pdf download. Usp 39 official monographs abacavir 2281 official monographs for usp 39. Usp 39, nf 34 general chapter operator protection from hazardous drugs presentation by. Chapter 1 the glossary of terms is usually included at the end of a manuscript. Now in the sepoct 2014 usp pharmacopeial forum for public comment. Download one of the free kindle apps to start reading kindle books on attraction marketing formula course and boot camp. Development of the antimicrobial effectiveness test as usp. Analytical balances select a checkweight of an appropriate mass to examine an analytical balance. Controlling for particulate matter in injectable drug. Identify hazardous drug substances used in compounding based on usp define usp guidelines for compounding.
Activities of the usp microbiology and sterility assurance. I hope he enjoys whatever journey awaits him in this infinite universe. This guide can be read as a pdf file or printed for future reference. Wealth attraction in the new economy the ultimate sales letter. Interim revision announcement official july 1, 2014. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. Elemental impurities in usp drug products and dietary supplements effective january 1, 2018, elemental impurities will be controlled in official drug products according to the principles defined and requirements specified in elemental. The new usp subvisible particulate matter in therapeutic protein injections test can be used as an alternative to usp.
This quick start guide will help you get started using the united states pharmacopeia usp pharmacopeial forum pf online application. Mathematical correlation between physical data and microbial effect is extremely poor. As an exercise, i researched the usps of the four competitors for my product. Usp general chapters and reference standards that support. The chapter provides guidance on setting strategies for identifying and characterizing the various particle populations in such products, during development as well as lifetime of the product. Understanding usp 797csps include the following types of preparations.
Magnetic marketing members hail from 50 us states and 25 countries. Dan kennedy was truly a legend and taught me so much. The way that this has been explained to me is as minimum weight. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. General chapters 41 balances and 1251 weighing on an analytical. General description this product is provided as delivered and specified by the issuing pharmacopoeia. As hell readily tell you, hes one of the worlds highestpaid copywriters. Defined physical parameters have proven problematic. Even though defining your usp is one of the best places to start when youre. I was deeply saddened with the news of his passing. The presence of particle contaminants has the potential for patient harm, especially among individuals considered to be in highrisk populations. Kindle edition by kennedy, dan s download it once and read. In the case of sterile articles packaged in multipledose containers. United states pharmacopeia 39, national formulary 34 usp, general chapter 800, appendix 2.
Usp outlines new limits in pharmaceutical products for arsenic, cadmium, lead and mercury. Briefing 786 particle size distribution estimation by analytical sieving, usp 27 pa ge 2335 a nd pa ge 1581 o f pf 28 5 s e pt. Presented at the pda europe parenteral packaging conference brussels, belgium 11 march 2014. Author dan kennedy goes through the familiar marketing basics. United states pharmacopeia usp and the european pharmacopeia ep 2. Whats new report from usp convention 2015 by nandu sarma and gabriel giancaspro, usp the 2015 usp convention meeting was held april 22 25 of this year at the jw marriott in washington, dc. Recent usp updates may,y, 20 don singer gsk bioburden control of nonsterile drug substances and products the chapter emphasizes control as a risk mitigation strategy thh d ikhe chapter recommends a riskbdbased approach to bioburden control in nonsterile drug products content of introduction guidance documents. Critical changes also are being made to incubation temperatures and duration. Usp convention meetings occur once every five years to bring together representatives from over 200. All information provided in support of this product, including sds and any product information leaflets have been developed and issued under the authority of the issuing pharmacopoeia. Founded by marketing legend dan kennedy in 1993, magnetic marketing publishes the famous no b. The interpretation of usp has had a lot of people confused.
Btw, the idea youre planting in your targets minds is that they call. The denver region, in which trimble has offices, offers a highly robust and competitive concentration of companies and industries for which research. Usp is a new informational chapter intended to supplement usp on measurement of subvisible particulate matter in therapeutic protein injections. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of. If possible, set the balance to read to 5 decimal places. Ever since the development of the earliest intravenous therapies, the presence of particulate matter in injectable drug products has been a concern among clinicians. For this reason, the ability to monitor those conditions is important in the shipping and storage of temperature and humidity sensitive preparations. Development of the antimicrobial effectiveness test as usp chapter scott v. Godspeed to him and comfort to his family and loved ones. The proposed replacements, usp chapters and, were first published in january of 2010 with subsequent updates made in 2011, 2012, and 20. The advantage of the combustion method is its high oxidation potential, especially for samples containing particulate matter.
Marketing letter each month and hosts conferences, bootcamps, intensives, and mastermindcoaching groups on a variety of marketing and business growth topics. In 2004, kennedy took on the world of cell phones, pdas, faxes, emails and every other communication device that pervade the lives of entrepreneurs and suggested when to tap it. No bs marketing to seniors and leading edge boomers, dan s. More organisms have been specified in the new usp chapter than in previous usp editions. Pda presentation sterile product package testing usp 1207. Installation guide unistream hmi panel usp 070b10, b08. Uspep 2668us std usd to unp, 042412 pharmaceuticals primary standards uspep usp usp standards table please also check our usp traceable secondary standard. Description unit size secondary standard usp408 abacavir sulfate 200 mg usp419 abacavir sulfate racemic 42amino6cyclopro. Parenteral drug association pda by claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems the recently revised united states pharmacopoeia usp chapter microbiological control and monitoring of aseptic processing.
According to usp, toc analyzers to be used for sterile water must satisfy the toc system suitability test using test water having a carbon content of 8. In addition to official articles, this index may also include items recently omitted from the uspnf in the indicated book. Methylsulfonylmethane united states pharmacopeia usp. Accusizer sis usp 787 subvisible particle sizing systems. The standards in this chapter do not pertain to the clinical administration of. Good storage and shipping practices1 internationally harmonized documents intended to assist. Dan kennedy ebooks epub and pdf format dan kennedy ebooks.
Pharmaceuticalthan those described in this chapter is not prohibited so long as they have been proven to be equivacompounding lent or superior with statistical significance to sterile preparationsthose described herein. Usp 1207 sterile product package integrity evaluation presented at the pda europe parenteral packaging conference. Pick up the checkweight with a forceps, place it carefully on the balance pan, and weigh it. In the case of this book, it is the opinion of the author that the terms required to interpret the united states pharmacopeia usp and the national formulary nf and understand their processes is more appropriately placed upfront in. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. The following index is for convenience and informational use only and shall not be used for interpretive purposes. The single calcudistribution practices for lated temperature at which the total amount of degrada tion over a particular period is equal to the sum of the.
Dan kennedys 14 steps to the ultimate marketing plan. Usp chapter 1207 package integrity evaluation sterile products the challenge of assuring integrity of a sterile package is more complicated than many realize. Technical specifications may be downloaded from the unitronics website. Without a usp, your product will fade into the shadows, struggle to complete and leave an. Examples of designs for hazardous drug compounding areas, 2016 according to it is recommended that the entity use two separate rooms for sterile and nonsterile hd compounding.
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