Dear students.
I wish you have good grades in the first partial. You can see that group activities are important in your score. This time you are going to be the first group to participate in this blog. I will share this information with BT and BQC the Friday so you have an advantage of one day.
I need that you select an official Mexican Norm useful in the matter (Pharma, cosmetic, food, environmental, biotechnology, etc)
You have to put all the code of the norm. The name of the norm in Spanish. The procedure to apply the norm. The limits that norm specifies to pass the norm and the utility of the norm.
Hint: You have to be very fast into participating because there are fewer norms than students. Those students at the end that not found any norm they will have to go to international norms and make the same process.
Have a nice day.
NOM-059-SSA1-2015,
ResponderEliminarYou have to put all the code of the norm. The name of the norm in Spanish. The procedure to apply the norm. The limits that norm specifies to pass the norm and the utility of the norm. If you do not do that it is abailable for others
EliminarNORMA Oficial Mexicana NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos.
EliminarThis Standard is mandatory for all establishments engaged in the manufacture and / or importation of medicinal products for human use marketed in the country and / or for research purposes, as well as laboratories for quality control, warehousing, warehousing and Distribution of medicines and raw materials for processing.
For the correct application of this Standard, it is necessary to consult the following Mexican official standards or those that substitute them:
.1 Norma Oficial Mexicana NOM-002/1-SCT/2009, Listado de las substancias y materiales peligrosos más usualmente transportados, instrucciones y uso de envases y embalajes, recipientes intermedios para graneles (RIG S), grandes envases y embalajes, cisternas portátiles, contenedores de gas de elementos múltiples y contenedores para graneles para el transporte de materiales y residuos peligrosos.
2.2 Norma Oficial Mexicana NOM-002-SEMARNAT-1996, Que establece los límites máximos permisibles de contaminantes en las descargas de aguas residuales a los sistemas de alcantarillado urbano o municipal.
2.3 Norma Oficial Mexicana NOM-005-STPS-1998, Relativa a las condiciones de seguridad e higiene en los centros de trabajo para el manejo, transporte y almacenamiento de sustancias químicas peligrosas.
2.4 Norma Oficial Mexicana NOM-020-STPS-2011, Recipientes sujetos a presión, recipientes criogénicos y generadores de vapor o calderas - Funcionamiento - Condiciones de Seguridad.
2.5 Norma Oficial Mexicana NOM-026-STPS-2008, Colores y señales de seguridad e higiene, e identificación de riesgos por fluidos conducidos en tuberías.
2.6 Norma Oficial Mexicana NOM-052-SEMARNAT-2005, Que establece las características, el procedimiento de identificación, clasificación y los listados de los residuos peligrosos.
2.7 Norma Oficial Mexicana NOM-062-ZOO-1999, Especificaciones técnicas para la producción, cuidado y uso de los animales de laboratorio.
2.8 Norma Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.
2.9 Norma Oficial Mexicana NOM-073-SSA1-2005, Estabilidad de fármacos y medicamentos.
2.10 Norma Oficial Mexicana NOM-087-SEMARNAT-SSA1-2002, Protección ambiental-Salud ambiental-Residuos peligrosos biológico-infecciosos-Clasificación y especificaciones de manejo.
2.11 Norma Oficial Mexicana NOM-164-SSA1-2013, Buenas prácticas de fabricación para fármacos.
2.12 Norma Oficial Mexicana NOM-220-SSA1-2012, Instalación y operación de la farmacovigilancia.
2.13 Norma Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos.
2.14 Norma Oficial Mexicana NOM-253-SSA1-2012, Para la disposición de sangre humana y sus componentes con fines terapéuticos.
2.15 Norma Oficial Mexicana NOM-257-SSA1-2014, En materia de medicamentos biotecnológicos.
2.16 Norma Oficial Mexicana NOM-020-STPS-2011. Recipientes sujetos a presión, recipientes criogénicos y generadores de vapor o calderas-Funcionamiento-Condiciones de seguridad
This rule establishes limits for:
Release of finished product.
Withdrawal of Product from the Market.
Qualification and validation.
Its usefulness is to have safe, stable and quality medicines. As well as having procedures standardized to have a transability and have an easy detection of anomalies. As well as reducing costs and giving advantage to research
Este comentario ha sido eliminado por el autor.
ResponderEliminarNORMA Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.
ResponderEliminarEste comentario ha sido eliminado por el autor.
EliminarNORMA Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.
EliminarThe procedure to apply the norm:
This rule is mandatory for all establishments related to the process of medicines or herbal remedies for human use that are marketed or supplied in the national territory.
For the correct application of this standard, it is suggested to consult the current version of the following standards:
• 3.1 Norma Oficial Mexicana NOM-050-SCFI-2004, "Información Comercial-Etiquetado General de Productos".
• 3.2 Norma Oficial Mexicana NOM-008-SCFI-2002, "Sistema General de Unidades de Medida".
• 3.3 Norma Oficial Mexicana NOM-073-SSA1-2005, "Estabilidad de Fármacos y Medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de Medicamentos, Publicada el 3 de agosto de 1996)."
• 3.4 Farmacopea de los Estados Unidos Mexicanos y sus suplementos vigentes.
The limits to pass the norm:
This rule contains the limits of the labeling and instructive of medicines and herbal remedies, which is the health and commercial information that identifies each drug or group of medicines of this type, as well as herbal remedies.
The utility to the norm:
Establish the requirements to be included in the labeling of the medicines and herbal remedies that are marketed or supplied in the national territory, its instructions and the labeling of the medical samples thereof.
Bibliography:
NORMA_OFICIAL_MEXICANA_NOM-072-SSAA1-2012.pdf. Retrieved March 8, 2017 from: http://www.dof.gob.mx/nota_detalle.php?codigo=5278341&fecha=21/11/2012
NORMA Oficial Mexicana NOM-007-SSA3-2011, Para la organización y funcionamiento de los laboratorios clínicos.
ResponderEliminarYou have to put all the code of the norm. The name of the norm in Spanish. The procedure to apply the norm. The limits that norm specifies to pass the norm and the utility of the norm. If you do not do that it is abailable for others
EliminarNORMA Oficial Mexicana NOM-007-SSA3-2011, Para la organización y funcionamiento de los laboratorios clínicos.
Eliminar1.1 This standard aims to establish the specifications that must be satisfied for the organization and operation of clinical laboratories.
1.2 This standard is mandatory for clinical laboratories, as well as professionals and technicians in the health area of the public, social and private sectors involved in the organization and operation of such establishments.
Para la correcta interpretación y aplicación de esta norma, es necesario consultar las siguientes Normas Oficiales Mexicanas o las que las sustituyan:
2.1 Norma Oficial Mexicana NOM-005-STPS-1998, Relativa a las condiciones de seguridad e higiene en los centros de trabajo para el manejo, transporte y almacenamiento de sustancias químicas peligrosas.
2.2 Norma Oficial Mexicana NOM-008-SCFI-2002, Sistema general de unidades de medida.
2.3 Norma Oficial Mexicana NOM-010-SSA2-2010, Para la prevención y control de la infección por Virus de la Inmunodeficiencia Humana.
2.4 Norma Oficial Mexicana NOM-012-STPS-1999, Condiciones de seguridad e higiene en los centros de trabajo donde se produzcan, usen, manejen, almacenen o transporten fuentes de radiaciones ionizantes.
2.5 Norma Oficial Mexicana NOM-087-SEMARNAT-SSA1-2002, Protección ambiental-Salud ambiental-Residuos peligrosos biológico-infecciosos-Clasificación y especificaciones de manejo.
2.6 Norma Oficial Mexicana NOM-168-SSA1-1998, Del expediente clínico.
2.7 Norma Oficial Mexicana NOM-197-SSA1-2000, Que establece los requisitos mínimos de infraestructura y equipamiento de hospitales y consultorios de atención médica especializada.
They should apply an internal quality control program for all laboratory studies they carry out, including the preanalytic, analytical and postanalytical stages.
They must participate in at least one external quality assessment program, in which they must integrate the laboratory studies they carry out and that includes the program, according to the needs of the clinical laboratory in terms of quality.
Documentary demonstration, which has carried out the evaluation of each of the tests included in external programs and develop a research directed to solve the problem of those laboratory studies in which the quality is not satisfactory.
NOM-087-ECOL-SSA1-2002, Protección ambiental-Salud ambiental-Residuos peligrosos biólogico-infecciosos-Clasificación y especificaciones de manejo.
ResponderEliminarThis Mexican Norm is mandatory for establishments that generate biological-infectious waste and third-party service providers that have a direct relationship with them
Limits that the Norm specifies
--Classification of dangerous biological-infectious waste
-----blood, crops and strains of agents biologico-infecciosos, pathological, non-anatomical waste,sharp object
--Classification of establishments generating hazardous biological and infectious waste
-----level I (HOSPITAL), level II(RESEARCH LABS ), level III(EXPERIMENTAL PRODUCTION CENTRES)
--Dangerous biological infectious waste
-----management comply with the provisions as appropriate: identification of waste, packaging, temporary storage, collection and transportation, treatment and final disposition
------Depending on the type of waste and their physical condition
------Universal symbol of biological risk
Utility: This Norm is useful since waste are handled in an appropriate way avoiding the spread of agents, whether they are pathogenic or not.
Este comentario ha sido eliminado por el autor.
ResponderEliminarYou have to put the limits that norm specifies to pass the norm and the utility of the norm. If you do not do that it is abailable for others
EliminarNORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos.
ResponderEliminarThis norm establish the requirements that must be included the processes, from the design of the installation, development, acquirement, preparation, mix, production, assemble, manipulation, packaging, stability, analysis, control, storage and distribution of medical devices commercialized within the country, by the type of product which is referring, and for aim to assure the compliance of criteria and requirements of quality and functionality to be used by the client or patient
This norm is obligatory in the national territory, for the entire establishment dedicated to the commerce of medical devices in Mexico.
Procedure to apply the norm: classification of medical devices, establishment organization, staff, documentation, design and construction of an establishment dedicated to the production, packaging, storage and distribution of medical devices, manufacturing control , manufacturing equipment, management of product out of specifications, claims and refunds, run off the product, validation, stability tests, control notifications, deviations, technical audits, destruction and final destination of hazard or contaminant residues, accordance with the international and national legislation.
Norma Oficial Mexicana NOM-109-SSA1-1994, Bienes y servicios. Procedimientos para la toma, manejo y transporte de muestras de alimentos para su análisis microbiológico.
ResponderEliminarIn the microbiological analysis of food, the proper selection of the sample, the correct intake, the means of conservation and its transport to the laboratory, its primary importance to obtain significant and reliable results. This means that the purpose of the study, the nature of the samples and the lacquering, the size of the volume, as far as possible, are representative of the product and the lot or item from which they originate.
Establishes the procedures for the transport and handling of food samples for their microbiological analysis
NORMA Oficial Mexicana NOM-257-SSA1-2014, En materia de medicamentos biotecnológicos.
ResponderEliminarNORMA Oficial Mexicana NOM-141-SSA1-1995, Bienes y servicios. Etiquetado para productos de perfumería y belleza preenvasados.
ResponderEliminarThis norm establishes the requeriments of sanitary information and comercial that must contain the label of products of perfumery and beauty.
NORMA Oficial Mexicana NOM-141-SSA1-1995, Bienes y servicios. Etiquetado para productos de perfumería y belleza preenvasados.
EliminarThis norm establishes the requeriments of sanitary information and comercial that must contain the label of products of perfumery and beauty to choose a better option of buy and avoid that it uses represent a health risk.
The products, intended to be marketed in the national market, must bear a label with the information established in this standard in "Spanish language", regardless of whether it may also be in other languages, taking care that the characters are greater or at least equal to those in which the information is presented in other languages
The generic and specific designation of the primary or secondary packaging must be shown in Spanish, except for the following products: fragrances, deodorants, antiperspirants, rinses, conditioners, fixatives, lotions, creams and gels, make-up, concealers , blushes, eye makeup, lip products, nail polish, toilet soaps and shaving creams, where it should appear on the information surface.
Este comentario ha sido eliminado por el autor.
ResponderEliminarNORMA Oficial Mexicana NOM-130-SSA1-1995, Bienes y servicios. Alimentos envasados en recipientes de cierre hermético y sometidos a tratamiento térmico. Disposiciones y especificaciones sanitarias.
ResponderEliminarThis Official Mexican Standard establishes the sanitary dispositions and specifications that must be complied with food packaged in sealed containers and subjected to heat treatment, with the exception of products that have specific Mexican Official Standards.
Este comentario ha sido eliminado por el autor.
ResponderEliminarNORMA OFICIAL MEXICANA NOM-118-SSA1-1994, BIENES Y SERVICIOS. MATERIAS PRIMAS PARA ALIMENTOS, PRODUCTOS DE PERFUMERÍA Y BELLEZA. COLORANTES Y PIGMENTOS INORGÁNICOS. ESPECIFICACIONES SANITARIAS.
ResponderEliminarThis Official Mexican Standard establishes the sanitary specifications that inorganic dyes and pigments must meet.
This Official Mexican Standard is of mandatory observance in the national territory for the physical or moral persons that are dedicated to its process or importation.
The limits specified are:
EliminarDEFINITIONS
SYMBOLS AND ABBREVIATIONS
CLASSIFICATION
HEALTH SPECIFICATIONS
SAMPLING
TEST METHODS
LABELED
PACKAGING AND PACKAGING
CONTROL
CONCORDANCE WITH INTERNATIONAL STANDARDS
The utility of the norm Is to satisfy the raw materials of sanitary quality, so that good manufacturing practices are applied. They are carried out in premises and facilities under hygienic conditions that assure that they are fit for use and human consumption, according to established by The General Health Law, its Regulations and other applicable provisions of the Ministry of Health.
NORMA Oficial Mexicana NOM-164-SSA1-2013, Buenas prácticas de fabricación para fármacos
ResponderEliminarThis Standard is mandatory for all establishments that are dedicated to the manufacture of drugs or active ingredients marketed in the country or drugs in development for use in clinical research and drug or active ingredients distribution deapot.
The limits specified are:
*Quality management
*The characteristics that the personnel has to have
*Instalation and equipment
*validation and calcification
*the production systems
* how it has to be the distribution of this drugs or active ingredients
* when it has to be rejected de product
*drugs for clinical trials
* waste treatment
The utility of this norm is that every single company or industry that is dedicated to produce medicines or active ingredients has to obey this norm to make a product of quality and to guaranty the safety when you use this drugs or active ingredients .
Cintia Joselyn Cázares Martínez BT
ResponderEliminarCode: SSA1-2009.
The name of the norm: NORMA Oficial Mexicana NOM-251-SSA1-2009, Prácticas de higiene para el proceso de alimentos, bebidas o suplementos alimenticios.
The procedure to apply the norm: This norm is mandatory for establishments that make food, beverages or supplements foodstuffs, the norm regulate all the activities that follow all the process for the food, beverages or supplements foodstuffs, since they are preparing, the people who prepare them, the facilities where they are prepared, their storage and distribution
The limits that norm specifies to pass the norm and the utility of the norm: The Establishments engaged in the processing of food, beverages or supplements foodstuffs, must comply with facilities that prevent contamination of raw materials, food, beverages or food supplements, the equipment must be installed in a way that has space, the drinking water must be available, appropriate facilities for storage and distribution, the storage conditions must be appropriate to the type of raw material, foods, beverages or dietary supplements that are handled, to avoid contamination, they can count on a HACCP System, establishments that prepare or elaborate foods, beverages or nutritional supplements must inspect or classify their raw materials and inputs before the production or processing of the product. The containers and containers that store food should avoid contamination. Water that is in direct contact with food, beverages, or food supplements should be potable and comply with the allowable limits of free residual chlorine and total and fecal coliform organisms. The equipment and utensils must be in good working order. The pest control is applicable to all areas of the establishment including transportation of food, beverages or dietary supplements. The measures should be taken for the periodic removal and storage of waste. People who are sick should be excluded from any operation in which they may contaminate the product, food, beverages or dietary supplements must be transported under conditions to avoid contamination All the personal operating in the production or processing areas must be trained in good hygiene practices, at least once a year.
The limits that are apply are the measurements of temperature, time, humidity level, pH, Aw and chlorine.
The utility of this norm is that all the process that has to do with food, beverages or dietary supplements properly elaborated and don´t cause damages in the society for contaminations that can be generated and so that the food process is adequate so that each of the products can go out for consumption in society.
The limits of the foods are: as the containers must have expiration date in force, the cans must be integrated, frozen foods without signs of thawing, refrigerated things must be at 4ºC or less, except fishery products which may be at 7 ° C, bottled drinks should be free of foreign matter, with fresh, lids, as for the meat the beef should be a bright red color, red lamb, pale pink pig, Firm and elastic texture, with characteristic smell, as for the birds firm texture and characteristic odor, the fish must have bright red gills with bulging eyes, clean, transparent, milk and derivatives must be pasteurized and cheeses with smell, color And characteristic texture.
EliminarDiana Gabriela Balmaceda Rivera BT
ResponderEliminarPROY-NOM-001-SAG/BIO-2014, Especificaciones generales de etiquetado de organismos genéticamente modificados que sean semillas o material vegetativo destinados a siembra, cultivo y producción agrícola.
The procedure: regulate the activities of contained use, experimental release, pilot release, commercial release, marketing, import and export of genetically modified organisms, hereinafter GMOs, in order to prevent, avoid or reduce the potential risks to these activities Could lead to human health, the environment and biological diversity, animal, plant and aquaculture health.
The limits: is applicable to natural or legal persons who intend to carry out sowing, cultivation and agricultural production with genetically modified organisms that are seeds or vegetative material in national territory. The information presented on GMO labels that are seeds or propagating plant material must be truthful, objective, described and presented in a way that does not mislead the user or users with respect to their nature and characteristics. Likewise, the language used should be clear and simple, ideas and/or phrases should not be used, which tend to the possible extension or exaggeration of the qualities or capacities real or that induce misuse. The words should be in common use avoiding to confuse the users.
The utility: in this NORM stablished it have to labeled all the GMO’s to have a better use and form a bank of this product. Beside it’s a project we can have a better result if this NORM were applied.
Este comentario ha sido eliminado por el autor.
ResponderEliminarPROY-NOM-259-SSA1-2014, Productos y servicios. Buenas prácticas de fabricación en productos cosméticos.
ResponderEliminarThis standard establishes the minimum requirements of the good practices of the manufacturing process of cosmetic products. This Standard is mandatory throughout the national territory for natural or moral persons engaged in the manufacturing process of cosmetic products.
Miranda Oaxaca Briseño BQC
ResponderEliminarNorma Oficial Mexicana: NOM-120-SEMARNAT-2011, Que establece las especificaciones de protección ambiental para las actividades de exploración minera directa, en zonas agrícolas, ganaderas o eriales y en zonas con climas secos y templados en donde se desarrolle vegetación de matorral xerófilo, bosque tropical caducifolio, bosques de coníferas o encinos.
The procedure: This norm will apply to those exploration projects
Mining operations in agricultural, livestock or wasteland areas and in areas with dry climates and vegetation of xerophytic scrub, deciduous tropical forest, conifers or oaks.
The limits are:
-Before conducting any direct mining exploration activity, they should verify posible existence of aquifers in the area in which it is intended to develop the activity so it doesnt reach to the freatic nivel.
-There will be no use of herbicide or any kind of chemical products during the activities of the project site.
-The hunting and extraction of species of flora and fauna by contracted personnel is prohibited.
-No excavation, leveling, compaction or filling of land outside the limits established in this standart.
-The material removed by the activities must be deposited in sites selected for this purpose, the responsable of the project should guaranteed that it will not be washed away by rainwater drainage or by the growth of bodies of water, which will not obstruct natural or similar channels and which will not affect other vegetation.
The utility of this norm is that some federal environmental impact activities can be regulated and measured such as the case of direct mining exploration activities, which are carried out in areas with dry and temperate climates where vegetation of xerophytic scrub, forest, deciduous tropical forest, conifer or oak forests and the
impact on the environment and the social environment, to be carried out in strict adherence to diverse requirements, specifications and procedures for environmental protection.
Bibliography:
NORMA_OFICIAL_MEXICANA_NOM-120-SEMARNAT2011.pdf. Retrieved January 27, 2017 from: http://www.gob.mx/cms/uploads/attachment/file/134143/26.-_NORMA_OFICIAL_MEXICANA_NOM-120-SEMARNAT-2011.pdf
NORMA OFICIAL MEXICANA NOM-093-SSA1-1994, BIENES Y SERVICIOS. PRACTICAS DE HIGIENE Y SANIDAD EN LA PREPARACIÓN DE ALIMENTOS QUE SE OFRECEN EN ESTABLECIMIENTOS FIJOS. Esta Norma Oficial Mexicana establece las disposiciones sanitarias que deben cumplirse en la preparación de alimentos que se ofrecen en establecimientos fijos con el fin de proporcionar alimentos inocuos al consumidor.
ResponderEliminarThe standard is of mandatory observance in the national territory for the natural or moral persons who are dedicated to the preparation of food and establishes the sanitary dispositions that must be fulfilled in the preparation of foods that are offered in fixed establishments in order to provide food safe to the consumer.
NOM-089-SSA1-1994 Bienes y Servicios. Métodos para la determinación del contenido microbiano en productos de belleza.
ResponderEliminarIt is about the different methods that are currently used in the industry for the determination of microorganisms in the different beauty products that are for sale in the country. This helps us to know the sanitary quality of the different products and to observe the ones that have better quality for sale and use of these in the consumers. For its application, the preparation of reagents and culture media that enter into the application of this NOM are specified. The preparation of the different samples is indicated for analysis, in one of its sections, there is talk about the identification of the pathogens according to the means recommended by this standard in addition to its macroscopic colonial characteristics.
GARCÍA BEJARANO ALEJANDRA/ Q.F.B.
ResponderEliminarNOM-179-SSA1-1998. Vigilancia y evaluación del control de calidad del agua para uso y consumo humano, distribuida por sistemas de abastecimiento público.
THE PROCEDURE TO APPLY THE NORM:
Determination of residual chlorine, the microbiological exam and the physical and chemical analysis. Following the preventive and corrective maintenance program.
THE LIMITS TO PASS THE NORM:
Determination of color, smell, tubing, if the water present particles of arsenic, barium, cadmium, etc.
And following the analysis of quality program of water.
THE UTILITY OF THE NORM:
The norm is useful to control the sanity of water and prevent the infection transmission for the human.
Establishes the requirements and specifications for the quality control of water.
OLVERA JASSO MICHELLE ANDREA BQC
ResponderEliminarNORMA Oficial Mexicana NOM-165-SEMARNAT-2013, Que establece la lista de sustancias sujetas a reporte
para el registro de emisiones y transferencia de contaminantes.
THE PROCEDURE TO APPLY THE NORM: This Official Mexican Standard establishes the list of substances subject to a federal competition report,
For the Register of Emissions and Transfer of Contaminants, its technical criteria and humiliation of reporting.
THE LIMITS TO PASS THE NORM:For a chemical to be subject to a PRTR report, it must be on the
Present Official Mexican Standard and comply with the established reporting threshold.
Persistent organic compounds, greenhouse gases and depleting substances in the layer
Ozone which are covered by binding international agreements of an international nature.
Mexico is a part and requires special handling.
THE UTILITY OF THE NORM:This Standard is mandatory throughout the national territory, for those responsible for
The fixed sources of federal jurisdiction, as well as for generators of hazardous waste in terms of
Provisions and, for those that discharge waste water into receiving bodies
National waters, provided they emit or transfer any of the substances
The list of this Official Mexican Standard, in amounts equal to or greater than the corresponding thresholds.
BIBLIOGRAPHY: NORMA Oficial Mexicana NOM-165-SEMARNAT-2013 Retrieved January 27 From: http://www.profepa.gob.mx/innovaportal/file/6640/1/nom-165-semarnat-2013.pdf
Karen Itzela Rivera Camargo
ResponderEliminarBT
Code of the norm: NOM-138-SEMARNAT/SS-2003
Name of the norm: NORMA OFICIAL MEXICANA NOM-138-SEMARNAT/SS-2003, LÍMITES MÁXIMOS PERMISIBLES DE HIDROCARBUROS EN SUELOS Y LAS ESPECIFICACIONES PARA SU CARACTERIZACIÓN Y REMEDIACIÓN.
Procedure to apply the norm:
This Official Mexican Standard is of mandatory observance throughout the national territory for those who are responsible for contamination with hydrocarbons in soils. In order to be able to apply the standard, it is necessary to locate with the UTM geographical coordinates the area of affectation in a plane to scale that allows its location at regional and local level, to determine the characteristics of the site that allow to evaluate the distribution of the contaminant and the degree of affectation and indicate The use of soil and the topography of the same.
Sampling must be adhered to the Sampling Plan developed, deviations to it must be justified and documented.
Samples to be taken on contaminated soil will always be simple (material collected at a single sampling point).
When a sample of the pollutant in free phase can be recovered, it must be delivered to the laboratory together with the soil samples to calibrate the analysis equipment and facilitate the identification of the type of hydrocarbon present.
Especific limits to pass the norm:
The maximum permissible limits for specific hydrocarbons in soil are varied in industrial soil, some are:
1. Toluene and Xylenes (100 mg / kg)
2. Benzo [k] fluoranthene (80 mg / kg)
3. Ethylbenzene (25 mg / kg)
4. Benzene (15 mg / kg)
5. Benzo [b] fluoranthene (mg / kg)
The analysis of medium fraction hydrocarbons should cover molecular weights between C10 and C28 and boiling points between 170 ° C and 430 ° C. The reference method is the EPA 8015B 1996 for Hydrocarbons Diesel Range (DRO). The quantitative determination should be performed with a gas chromatograph with a non-polar capillary column and flame ionization detector. As a result a peak profile is obtained whose separation is in function of the molecular weights of the hydrocarbons present.
Utility of the norm:
It is very useful since it establishes the maximum permissible limits of hydrocarbons in soils and the specifications for their characterization and remediation.
Bibliography:
NORMA_OFICIAL_MEXICANA_ NOM-138-SEMARNAT/SS-2003.pdf. Retrieved January 27, 2017 from: http://www.bdlaw.com/assets/htmldocuments/Mexico%20-%20NOM-138.pdf
Norma Oficial Mexicana NOM-051-SCFI/SSA1-2010 que establece las nuevas especificaciones para el etiquetado de alimentos y bebidas no alcohólicas pre-envasados
ResponderEliminarGONZALEZ ATANACIO MARISOL
ResponderEliminarNORMA Oficial Mexicana NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios.
THE PROCEDURE FOR THE APPLICATION OF THE STANDARD: This Standard sets out the specifications and requirements of stability studies, their design and implementation, which must be made to drugs, medicines, and herbal remedies for human use, which Commercialize in national territory, as well as those medicines for research purposes.
THE LIMITS TO PASS THE NORM: This Standard is mandatory for factories or laboratories of raw materials for the manufacture of medicines or biological products, for human use and factories or laboratories of medicines or biological products for human use or factories or laboratories of Herbal remedies, which produce drugs, medicines, as well as herbal remedies, which are marketed in the United Mexican States.
THE UTILITY OF THE NORM: Stability studies provide documented evidence of how the quality of a drug or drug varies over time, under the influence of environmental factors such as temperature, humidity, or light. The studies allow to establish storage conditions, periods of analysis and shelf life for a new or known drug, new or known drugs and the specific generalities that each pharmaceutical form must comply with in accordance with this standard. (HEALTH, 2015)
Bibliography
HEALTH, S. D. (26 of 02 of 2015). Official Mexican NOM-073-SSA1-2015, Stability of drugs and medicines, as well as herbal remedies. Retrieved from "http://www.salud.gob.mx/unidades/cdi/nom/073ssa105.html"
Samuel Aubert Romero de la Vega
ResponderEliminarNOM-EM-001-SSA1-2012.
Medicamentos biotecnológicos y sus biofármacos. Buenas prácticas de fabricación. Características técnicas y científicas que deben cumplir éstos para demostrar su seguridad, eficacia y calidad. Etiquetado. Requisitos para realizar los estudios de biocomparabilidad y farmacovigilancia.
The procedure to apply the norm is to carry out good practices in the manufacture of biopharmaceuticals and biotechnological medicines, to register the biotechnology medicines against COFEPRIS, to follow up on the pharmacovigilance of biotechnological medicines, to subject biotechnology drugs to Authorized Third Parties, research centers or hospital institutions that Perform the biocomparability tests.
The utility of the norm, was to provide that all biotechnology medicines must obtain the sanitary registration, provided they have met the requirements and tests that demonstrate the quality, safety and efficacy of the product, and establishes the requirements for verifying the quality, safety and efficacy of medicines Innovative and biocompatible biotechnologies, depending on the characteristics and complexity of their own nature. This official Mexican standard establishes the requirements for the sanitary control of biopharmaceuticals and biotechnology drugs, the technical and scientific characteristics that must be met by biotechnological medicines, to demonstrate their safety, efficacy and quality, the requirements that must be contained in the labeling of biotechnological medicines and their instructions, the criteria and requirements to be met by applicants for a biotechnology health registry, Authorized Third Parties, Research Centers or Hospital Institutions carrying out tests to demonstrate the biocomparability of biocompatible biotechnology medicines, guidelines on Which must carry out the activities of pharmacovigilance of biotechnological drugs. The scope of application for this official Mexican standard is mandatory for holders of the health registry, establishments dedicated to the process of biopharmaceuticals and biotechnological medicines and for all applicants for a sanitary registration of biotechnologists, Authorized Third Parties, Research Centers or Hospital Institutions To carry out the tests to demonstrate biocompatibility, as well as the tests determined by the Ministry of Health.
The limits that norm specifies to pass the norm, the biotechnology medicines need to pass Biocomparability Studies like phase IA Clinical Safety Increasing single dose, phase IA Biocompatibility Studies Clinical and PK / PD Safety, phase III Biocomparability Studies: Therapeutic Equivalence and Clinical Safety.
Bibliography: http://www.dof.gob.mx/nota_detalle.php?codigo=5269530&fecha=20/09/2012 Official Mexican Norm NOM-EM-001-SSA1-2012.
NOM-010-SSA2-2010
ResponderEliminarNORMA Oficial Mexicana NOM-010-SSA2-2010, Para la prevención y el control de la infección por Virus de la Inmunodeficiencia Humana.
Procedure to apply the norm: Mandatory in all national territory for all institutions and personnel of the National Health System involved in the care of people living with the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome, including staff who carry out advocacy and prevention Health, specific protection, treatment, primary care and epidemiological control, as well as for personnel working in health units that include those working in public and private laboratories.
The limits that norm specifies to pass the norm: If the result is positive the sample is analyzed with a second test using antigens and/or platform different from the first test. A second test with a positive or repeatedly reactive result is considered to indicate a true positive result in populations with HIV prevalence of 5% or more.
Promote and train health personnel in universal biosafety measures to reduce the risk of HIV transmission that occurs through the management of instruments, procedures and products used in medical, laboratory and dental areas, as well as in the utilization Of sharps, giving preference to the use of disposable material and, where this is not possible, for such instruments to be sterilized and disinfected
Always handle tissues, excreta and body fluids as potentially infected and give them final destination by incineration or viral inactivation, by sterilization with autoclave or using solutions of sodium hypochlorite of 4 to 7%. Corpses should be considered as potentially infected and standard precautions should be followed; Their incineration should not be mandatory
Utility of the norm: Strengthen the prevention, care and control of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome through the promotion of health through actions aimed at developing attitudes favorable to health, generating favorable environments, reinforcing community action, reorienting services Health and promote public policies in this area; As well as providing a comprehensive care service for people with HIV / AIDS
Bibliography: http://www.spps.gob.mx/images/stories/SPPS/Docs/nom/NOM-010-SSA2-2010.pdf
Juan Andreus Cerda Loza
ResponderEliminarNOM-131-SSA1-1995
Bienes y servicios. Alimentos para lactantes y niños de corta edad. Disposiciones y especificaciones sanitarias y nutrimentales.
This Official Mexican norm establishes the sanitary and nutritional specifications to be followed by infant formulas and follow-on formulas, packaged foods for infants and young children, and cereal-based foods for infants and young children. This Official Mexican norm is of mandatory observance in the National Territory for the natural and moral persons that are dedicated to its process or importation.
The utility is to have a control in the food for infants and children, on either ingredients and a control in the microorganisms so as not to have infections in this sector of the population
the limits in microorganisms in this type of food are
Mesofílicos aerobios 10 000 UFC/g
Salmonella spp en 25g Ausente Staphylococcus aureus Negativo Coliformes totales 20 NMP/g Escherichia coli Negativo
http://www.google.com.mx/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0ahUKEwj80uPgssjSAhVH7xQKHfRLDhEQFggsMAM&url=http%3A%2F%2Fwww.institutodanone.org.mx%2Fdocs%2FNOM-131_SSAA1-1995.pdf&usg=AFQjCNE1Z5t2w_8o3kIwWBfFWbi1XedO3w
NOM-039-SSA1-1993
ResponderEliminarBIENES Y SERVICIOS. PRODUCTOS DE PERFUMERÍA Y BELLEZA. DETERMINACIÓN DE LOS ÍNDICES DE IRRITACIÓN OCULAR, PRIMARIA DÉRMICA Y SENSIBILIZACIÓN
This Official Mexican Standard establishes the test methods to determine the indexes of ocular irritation, dermal primary and sensitization, as well as the maximum limits of acceptance.
Perfumery and beauty products are formulations that contain chemicals and ingredients that can cause injury to the eyes or skin, since they are in everyday use, it is important to check that their contents are safe. In order to determine whether a product is irritant or sensitizing, the first tests were carried out on animals, such as the Draize Test. These in vivo tests showed that there were quantifiable visible changes. Nowadays, in addition to these, human-induced patch tests are performed, both of which are useful for evaluating the damage that these products may present.
The limits are LIVE TESTS
IN VITRO TESTS and SAMPLING
http://www.salud.gob.mx/unidades/cdi/nom/039ssa13.html
Jonathan Cocoletzi Bautista
ResponderEliminarNORMA Oficial Mexicana NOM-213-SSA1-2002, Productos y servicios. Productos cárnicos procesados. Especificaciones sanitarias. Métodos de prueba.
This Official Mexican Standard establishes the sanitary specifications that the processed meat products must comply with.
This Official Mexican Standard is of mandatory observance in the national territory for the physical or moral persons that are dedicated to its process or importation.
The procedure for applying the standard
In addition to complying with what is established in NOM-120-SSA1-1994. Practices of hygiene and sanitation for the process of food, non-alcoholic beverages and alcoholic, must comply with the microbiological specifications established in NOM-127-SSA1-1994 among others.
Personnel in the production area should wear work clothes, rubber or industrial footwear and overcoat. Personnel who come into contact with the product should wear masks. Armholes and rubber footwear should be washed and disinfected at least at the beginning, re-entering the processing areas and at the end of the day. The establishment must provide clean work clothes. Personnel should wash and disinfect their hands and forearms, as well as brush their nails before entering the process areas.
The utility of the standard
Products and services. Processed meat products. Sanitary specifications. Test methods.
Bibliography:
NORMA_OFICIAL_MEXICANA_NOM-213-SSA1-2002.pdf. Retrieved March 9, 2017 from: http://www.salud.gob.mx/unidades/cdi/nom/213ssa102.html
Norma Oficial Mexicana NOM-047-SSA1-1993, QUE ESTABLECE LOS LIMITES BIOLOGICOS MAXIMOS PERMISIBLES DE DISOLVENTES ORGANICOS EN EL PERSONAL OCUPACIONALMENTE EXPUESTO
ResponderEliminarProcedures to evaluate the risk to the health
1.- In case the environmental and biological monitorings do not exceed the established limits previously, it is considered that the worker is toiling in suitable conditions.
2.-n case the environmental monitoring does not exceed the permissible limits, but the biological monitoring is altered, will retire the worker of the work place, to put him or her under a medical evaluation. In order to avoid the worker suffers an irreversible damage.
3.- In case the environmental monitorings exceed the maximum-permisible-levels of concentration and the biological monitoring is altered, the specified measures of control are due to establish n NOM-010 STPS-1993, and to retire the worker of its work area, in order to avoid major damages to the personnel occupational exhibited.
SPECIFICATIONS
Biological limits of industrial exhibition
Benzene: Total phenols in urine at the end of the work turn: 50 mg/gr creatinine
Toluene:Hippuri acid in urine at the end of the work turn: 2.5 gr/gr of creatinine
Toluene in venous blood at the end of the work turn 1 mg/l
Xylene: Metylhippuric acid in urine at the end of the work turn: 1.5 gr/gr of creatinine
Criteria for the conservation of workers' health.
Given the toxicological characteristics of aromatic hydrocarbons of the benzene, xylene and toluene type, the following criteria must be met for the assessment of the health status of workers exposed to these substances.
Reference:
http://www.salud.gob.mx/unidades/cdi/nom/047ssa13.html