RDC_166_2017_Anvisa-Ingles

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RDC 166/2017 – AnvisaParagraph 4. Microbiological methods, for which technical justification for the chosenapproach should be provided, based on the Brazilian Pharmacopeia or other officialcompendia recognized by Anvisa, are excluded from this resolution.Section IIIDefinitionsArt. 3 For purposes of this resolution, the following definitions are adopted:I - sample: representative amount of pharmaceutical ingredient, intermediate orfinished product, duly identified, before the determined expiration date;II - analyte: substance or group of substances of interest whose identification orquantification is intended;III - chemical substance characterization: the set of tests that undoubtedlyassures the authenticity and quality of substance regarding its identity, purity,content and potency, which must include data obtained through techniquesapplicable to each substance characterization, such as, for example,thermogravimetric analysis, melting point, differential scanning calorimetry, infraredspectroscopy, mass spectrometry, nuclear magnetic resonance, elementalanalysis (carbon/hydrogen/nitrogen), X-ray diffraction, optical rotation,chromatographic test, among others;IV - analytical run: set of measurements performed in a pool of samples in a predeterminedtime interval under the same conditions of repeatability, such as method,analyst, instruments, place and use conditions;V - matrix effect: effect of matrix components on the analytical response;VI - test: technical operation consisting of the determination of one or morecharacteristics of a certain ingredient or product, according to a specified method;VII - limit test: test that allows checking if the amount of analyte is above or below apre- determined level without quantifying such analyte precisely;VIII - response factor: ratio between the analytical sign and the analyteconcentration;IX - relative response factor: ratio between response factors that is used ascorrection in the calculation of the concentration of a substance when suchsubstance is measured by the analytical response of another substance;X - quality management: determines the implementation of “Quality Policy”, thatis, global intentions and guidelines related to quality, which is formally expressed andPágina 2 de 18This text does not replace the one(s) published in the Official Gazette Brazil. Translation for consultation. Translation not sworn.
RDC 166/2017 – Anvisaauthorized by the company’s high administration;XI - impurities: any component present in the pharmaceutical ingredient of finishedproduct that is not the active pharmaceutical ingredient nor the excipient(s);XII - pharmaceutical ingredient: any substance that is part of the formulation of adosage form;XIII - active pharmaceutical ingredient (API): pharmaceutical ingredient that, whengiven to a patient, acts as active ingredient, and may have pharmacological activityor direct effect on the diagnosis, cure, treatment or prevention of a disease or alsoaffect the structure and function of human body;XIV - complex matrix: the one containing an indefinite number of unmonitoredsubstances that cannot be obtained without the presence of the analyte;XV - matrix: composition that mimics the sample without the presence of theanalyte;XVI - investigational products: experimental drug, placebo, active comparator or anyother product to be used in the clinical trial;XVII - chromatographic purity: absence of interference with the analytechromatographic signal;XVIII - peak purity: spectral homogeneity of a chromatographic peak indicating itschromatographic purity, and the criteria to define if there is spectral homogeneity andthe parameters adopted for the purity calculation are defined as pre-determined inthe software used or by scientifically-based technical evaluation;XIX- validation report: document that consolidates and summarizes the procedures,records, results and validation evaluation;XX - analytical method revalidation: partial or total repetition of the validation of ananalytical method to assure that it still meeting the established requirements;XXI- chemical reference substance (CRS): substance or mixture of chemical or biologicalsubstances with high purity level that is carefully characterized to assure its identity,quality, content and potency, including the characterized chemical referencesubstance and pharmacopeia chemical reference substance;XXII - characterized chemical reference substance (CCRS): substance or mixture ofchemical or biological substances whose identity, quality, purity, content and potencyhave been carefully assured by a characterization process;XXIII - pharmacopeia chemical reference substance (PCRS): substance ormixture of chemical or biological substances established and distributed by officialPágina 3 de 18This text does not replace the one(s) published in the Official Gazette Brazil. Translation for consultation. Translation not sworn.
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RDC_166_2017_Anvisa-Ingles

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