Regulatory perspective on key usp general chapters in microbiology. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Injections33 general chapters general tests and assays 1. The national institute for occupational safety and health niosh considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or.
The types of chromatography useful in qualitative and quantitative analysis that are employed in the usp procedures are column, gas, paper, thinlayer, including highperformance thinlayer chromatography, and pressurized liquid chromatography commonly called highpressure or highperformance liquid chromatography. Be media should be labeled properly with batch or lot numsure that the cleaning process removes debris and foreignbers. Usp and usp microbiological examination of nonsterile products microbial enumeration testing labs. Microbiological best laboratory practices general information usp 35 glassware or from prior materials used in the glassware. The new draft general chapter usp 60 became official on december 1, 2019 designed as an extension of usp61 62 general chapters and to increase the probability of detection of the bcc over the current methods described in usp62. Drug injectionliquid preparations that are drug general requirements for substances or solutions thereof. Usp updates and for microbial testing of nonsteriles. Drug for injectiondry solids that, upon the addi tests and assays tion of suitable vehicles, yield solutions conforming in all respects to the requirements for injections. Entire chapter and revisions marked for iraofficial may 1, 2009. Usp nf sf in which s is the volume, in ml, of the reagent consumed in the second titration. In december 2014, a new version of usp officially went into effect. The method can be used to assess the microbiological quality of everything from face lotion to a diagnostic reagent.
In the pharmaceutical industry, the united states pharmacopoeia usp set of standards for managing balances is widely recognized around the world. Microbial examination of nonsterile products is performed according to the methods given in the texts on microbial. Critical changes also are being made to incubation temperatures and duration. Sample preparation and preincubation prepare a sample using a 1 in 10 dilution of not less than 1 g of the product to be examined as described in microbiological examination of nonsterile products. Commentary for pf 39 1 stage 6 harmonization commentary only no comments received when proposed in pharmacopeial forum. All technologies must discriminate between the inorganic carbon, which may be present in the water from sources such as dissolved co 2. As part of an ongoing monograph modernization initiative, the united states pharmacopeial convention usp is updating this general chapter, 1086 impurities in drug substances and drug products, and proposing a new chapter, 476 organic impurities in drug substances and drug products, which addresses organic impurities testing for articles with. General chapters preparation of test strains use standardized stable. Federal food, drug, and cosmetics act designates the usp nf as the official compendia for.
Analytical technologies utilized to measure toc share the objective of completely oxidizing the organic molecules in an aliquot of sample water to carbon dioxide co 2, measuring the resultant co 2 levels, and expressing this response as carbon concentration. The tests for specified microorganisms are included in usp 62, the modifications change many microbiological medias utilized in testing for specific pathogens. This article provides an overview of usp chapter 62. Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the usp pharmacopeial method, will also be examined as part of usp 61 62.
Added antimicrobial preservatives must be declared on the label. When objectionable microorganisms are not specified in the individual monograph, it is the manufacturers. Pharmaceutical drug products with water activities well below 0. Pharmaceutical testing usp updates and for microbial. Prepare the eggyolk emulsion by disinfecting the surface of whole shell eggs, aseptically cracking the eggs, and separating out intact yolks into a sterile. Developing usp general chapter usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. United states pharmacopeia and national formulary usp 37 nf 32 s2 baltimore, md. Strains of the test microorganisms suitable for use in for products containing a mercurial preservative that cannot the growth promotion test and the method suitability be tested by the membrane filtration method, fluid thiogtest continued. More organisms have been specified in the new usp 62 chapter than in previous usp editions. Method ib residual titration principlesee the information given in the section principle under method ia.
Verification of compendial procedures1 terial to which the procedure is applied. This version of is part of the second supplement to usp 37 nf 32. Pharmacopoeia usp29 good storage and shipping practicesgeneral chapters 1079 good storage and shipping practices this general information chapter is intended to provide general guidance concerning storing, distributing, and shipping of. In addition, usp 61 and 62 form the basis for many other usp general chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing. Usp microbiological examination of nonsterile products. A balancing quantity of cations, such as sodium ion, is. More organisms have been specified in the new usp chapter than in previous usp editions. For the gelclot technique, a heat block that maintains a 37 1c temperature is required. Microbiological examination of nonsterile products uspnf.
Microbiological best laboratory practices, usp chapter is a living informational reference, which means that as the expert committee sees or hears of potential improvements, the chapter can be updated. Microbiological examination microbiological tests usp 31 fatty productsdissolve in isopropyl myristate sterilized bygauze to prevent the patches from sticking together, and transfer filtration, or mix the product to be examined with the minimumthe patches to a suitable volume of the chosen diluent containing. This real time live training program will provide the foundation and framework to develop a strong. At its core, usp is a wellcontrolled aerobic plate count assay that includes a complete neutralization and recovery analysis.
Usp s chemical analysis expert committee and kahkashan zaidi a abstract the chemical analysis expert committee caec is evaluating the idea of removing. This chapter describes the testing of nutritional and dietary articles for specified microorganisms, which are specified in the individual monographs or whose absence is recommended by the guidance under microbiological attributes of nonsterile nutritional and dietary supplements 2023. Usp general chapter provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Microbial enumeration tests 61, and use 10 ml or the quantity corresponding to 1 g or 1 ml to inoculate a suitable amount determined as described under suitability of the test method of. Commentary usp 36nf 31 prescription container labeling. United states pharmacopeia scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines usp s drug standards are enforceable in the united states by the food and drug administration the u. In the residual titration, excess reagent is added to the test specimen, sufficient time is allowed for the. Usp chapters and implementation strategy kahkashan zaidi, ph. Proposed for development version posted october 15, 2019. The conductivity of the ubiquitous chloride ion at the theoretical endpoint concentration of 0.
Since the official chapter was first published, and as part of a quality improvement plan for a usp chapter, both expert committee and comments from the public already have led to some. Microbiological examination3 containing respectively 0. Combined index to usp 38 and nf 33 alumiammon i3 aluminacontinued zirconium trichlorohydrex gly solution, oral solution, 2188 aspirin, and magnesia tablets, 2297 2159 rectal solution, 2189 aspirin, and magnesium oxide tablets, aluminum. The tests and criteria for effectiveness apply to a product in the original, unopened container in which it was distributed by the manufacturer. Verification of revalidation of a compendial method is not required to verify the suitability of a procedure under actual conditions of compendial procedures use, some of the analytical performance characteristics listed. This chapter provides tests to demonstrate the effectiveness of antimicrobial protection. Heat with frequent agitation, and boil for 1 minute. Thermo scientific orion ph meter kits are part of a highquality ph test method designed to assist with compliance to usp. The current good manufacturingof a characteristic obtained by carrying out a specified test practice regulations 21 cfr 211. Usp 38 the united states pharmacopeia 1nf 33 the national formulary volume 4a by authority of the united states pharmacopeial convention prepared by the council of experts and its expert committees official from may 1, 2015 the designation on the cover of this publication, usp nf 2015, is for ease of identification only. Paper and thinlayer chromatography are ordinarily more useful for purposes. Proposed for development version posted january 6, 2020. In accordance with usp s rules and procedures of the council of experts rules, and except as provided in section 7.
According to usp general chapter balances, for substances to be accurately weighed, the balance used must be calibrated over the operating range and meet the following requirements defined for repeatability and accuracy. Heavy metals deletion date o jan 1, 2018 publish omission of general chapter o published in usp 38nf 33 with an official date of december 1, 2015. Exclusion of objectionable microorganisms from nonsterile. Usp is the chapter that describes microbial examination of nonsterile products. Combined index to usp 42 and nf 37 abacaacety i1 combined index to usp 42 and. Subculture each of the cultures on asample preparation and preincubationprepare a sample. Water for pharmaceutical purposes general information first supplement to usp 35nf 30 dbp levels in drinking water can be minimized by using purified waterpurified water see the usp monograph disinfectants such as ozone, chloramines, or chlorine dioxis used as an excipient in the production of nonparenteral. Sterilize, cool to between 45 and 50, and add 10 ml of sterile potassium tellurite solution 1 in 100 and 50 ml of eggyolk emulsion. Solutions having the same solvent composition as the sample solution.
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