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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. If you do not do that it is abailable for others. For the correct application of this Standard, it is necessary to consult the following Mexican official standards or those that substitute them:.
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. The 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.
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.
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.
You have to put the limits that norm specifies to pass the norm and the utility of the norm. This 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.
In 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. This norm establishes the requeriments of sanitary information and comercial that must contain the label of products of perfumery and beauty.
This 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.
Disposiciones y especificaciones sanitarias. This 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.
This 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. 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.
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 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. The words should be in common use avoiding to confuse the users. This 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. 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. 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.
The 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.
It 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.
Following the preventive and corrective maintenance program. And following the analysis of quality program of water. Establishes the requirements and specifications for the quality control of water.
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. 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.
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.
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. 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.
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.
Principios generales y procedimientos. ISO This international standard contains the principles and procedures for the development of Type I eco-labeling programs, including the selection of product categories, product criteria and functional characteristics of the product; And for assessment and demonstration of conformity.
This standard also establishes certification procedures for granting the eco-label. 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. 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.
Especificaciones sanitarias. This Official Mexican Standard establishes the sanitary specifications that the processed meat products must comply with. Practices of hygiene and sanitation for the process of food, non-alcoholic beverages and alcoholic, must comply with the microbiological specifications established in NOMSSA 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. In order to avoid the worker suffers an irreversible damage. 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. Dear students.
Regulatory Guidelines on Stability Testing and Trending of Requirements
That on the August 20, , in compliance with the agreement of the Committee and that foreseen in article 47, fraction 1 of the Federal Law on Metrology and Normalization, the project of the present Official Mexican Norm was published in the Official Gazette of the Federation, the project of the present Official Mexican Norm, in order that, during the following sixty calendar days after the said publication, the interested parties will present their comments to the National Advisory Committee for the Standardization of the Sanitary Regulation and Development. That, dated previously, published in the Official Gazette of the Federation, the answers to the comments were received by the above-mentioned Committee, under the terms of article 47, paragraph III of the Federal Law on Metrology and Normalization. Introduction This Official Mexican Standard is issued in order to establish the requirements of the stability studies that should be performed to the drugs and medications commercialized in Mexico. Objective The purpose of the stability studies is to provide documented evidence of how the quality of a drug or medication varies with time, because of environmental factors such as temperature, humidity and light. The studies allow to determine the appropriate storage conditions, retest period and shelf-life. Scope This Official Mexican Standard is to be observed within the national territory for: Manufacturing plants or Laboratories of Raw Materials for the elaboration of medicines or biological products for Human consumption and Manufacturing Plants or Laboratories of Medications or Biological Products for Human Consumption.
Mexico Adopts New Standards on Stability of Pharmaceuticals and Herbal Products
Mexico Nom 073 Ssa1 2005 English Corr
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