DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of July 17, 2018 № 113

About approval of the Management on validation of analytical techniques of carrying out testing of medicines

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 3 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 the Board of the Euroasian economic commission decided:

1. Approve the enclosed Management on validation of analytical techniques of carrying out testing of medicines.

2. This Decision becomes effective after 6 months from the date of its official publication.

Approved by the Decision of Board of the Euroasian economic commission of July 17, 2018 №113

Management on validation of analytical techniques of carrying out testing of medicines

I. General provisions

1. In the present manual rules of validation of analytical techniques of carrying out testing of medicines, and also the list of the characteristics which are subject to assessment in case of validation of the specified techniques and to inclusion in the registration files submitted to authorized bodies of state members of the Eurasian Economic Union are determined (further respectively – state members, the Union).

2. The purpose of validation of analytical technique of carrying out testing of medicines is documentary confirmation of its suitability for purpose.

II. Determinations

3. For the purposes of the present manual concepts which mean the following are used:

"analytical technique" (analyticalprocedure) – technique of carrying out testing of medicines which includes the detailed description of the sequence of the actions necessary for accomplishment of analytical testing (including the description of training of examinees of samples, standard samples, reactants, uses of the equipment, creation of calibration curve, the used settlement formulas etc.);

"reproducibility" (reproducibility) – the property characterizing precision in interlaboratory researches;

"the application range (analytical area)" (range) – interval between the greatest and smallest concentration (quantity) of the determined substance in sample (including these concentration) for which it is shown that the analytical technique has the acceptable level of precision, correctness and linearity;

"linearity" (linearity) – directly pro rata dependence of analytical signal from concentration (quantity) of the determined substance in sample within the application range (analytical area) of technique;

"recovery(recoverability)" – ratio between the received average and true (basic) values taking into account the corresponding confidential intervals;

"repeatability (precision in technique)" (repeatability (intra-assayprecision)) – technique precision in case of accomplishment of re-testing in identical operating conditions (for example, the same analyst or group of analysts, on the same equipment, with the same reactants etc.) during short period;

"correctness" (accuracy, trueness) – proximity between the accepted true (basic) value and the received value which is expressed by open rate size;

"limit of quantitative determination" (quantitationlimit) – the smallest amount of substance in sample which can be determined quantitatively with the corresponding precision and correctness;

"detection limit" (detectionlimit) – the smallest amount of the determined substance in sample which can be revealed, but is optionally precisely quantitatively determined;

"precision" (precision) – expression of proximity (dispersion degree) of results (values) between series of the measurements taken on set of the samples taken from the same homogeneous test in the conditions ordered by technique;

"intermediate (intra laboratory) pretsizionnost" (intermediateprecision) – influence of variations in laboratory (different days, different analysts, the different equipment, different series (batches) of reactants etc.) on results of testing of the identical samples which are selected from the same series;

"specificity" (specificity) – the determined substance irrespective of other substances (impurity, degradation products, excipients, matrix (environment), etc.) which are present at the examinee sample is unambiguous to estimate capability of analytical technique;

"stability (robustness)" (robustness) – capability of analytical technique to be steady against influence of the little set changes in the conditions of carrying out testing which specifies its reliability in case of regular (standard) use.

III. Types of the analytical techniques which are subject to validation

4. In the present manual approaches to validation of 4 most widespread types of analytical techniques are considered:

a) testing for identification (authenticity);

b) testing for determination of quantitative content of impurity (quantitativetestsforimpuritiescontent);

c) testing for limiting determination of content of impurity in test (limittestsforthecontrolimpurities);

d) quantitative testing (on content or activity) (quantitativetestsoftheactivemoiety) for determination of active part of molecule of active ingredient in the examinee sample.

5. All analytical techniques used for quality control of medicines need to be validirovat. In the present manual validation of analytical techniques for types of the testing which are not included in item 4 of the present manual is not considered (for example, testing for dissolution or determination of the particle size (dispersion) of pharmaceutical substance, etc.).

6. Testing for identification (authenticity) consist, as a rule, in comparison of properties (for example, spectral characteristics, chromatographic behavior, chemical activity etc.) the examinee and standard is exemplary.

7. Testing for determination of quantitative content of impurity and testing for limiting determination of content of impurity in test are directed to the correct measure description of purity of test. Requirements to validation of techniques of quantitative determination of impurity differ from requirements to validation of techniques of limiting determination of content of impurity in test.

8. Techniques of quantitative testing are directed to measurement of content of the determined substance in the examinee sample. In the present manual quantitative determination is understood as quantitative measurement of the main components of pharmaceutical substance. Similar validation parameters are applicable concerning quantitative determination of active ingredient or other components of medicine. It is allowed to use validation parameters of quantitative determination in other analytical techniques (for example, when testing for dissolution).

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