VALIDATED METHOD

10 The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.

Inactivated by validated means

have been properly technically validated before use,

Results from well-validated alternative studies;

supplement and validate the impact assessment procedure,

Inactivated by validated chemical means

The method validated in the application is as follows:

issued under 21A.130 and validated by the Competent Authority,

issued under 21A.130 and validated by the Competent Authority

The readout for PT is to be done in seconds, because the INR (International Normalized Ratio) is only calibrated and validated for coumarins and cannot be used for any other anticoagulant.

DATA VALIDATION PROCEDURE AND QUALITY ASSURANCE

a published, validated procedure with an established repeatability.

Inactivated by validated chemical or physical means

EVALUATION OF ANALYTICAL RESULTS OBTAINED USING VALIDATED METHODS

Critical phases of manufacturing processes shall be regularly re-validated.

At least the critical process steps, such as sterilisation, shall be validated.

It is necessary that a validated method of analysis exists for the enforcement of the maximum levels.

Otherwise, the inspection shall not continue and therefore the release certificates shall not be validated;

Any new manufacture or important modification of a manufacturing process shall be validated.

Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model.

to approve validated methods as reference methods, to be integrated into a collection of methods;

The "validated average values" are determined as set out in point A.6 of Annex VIII.

The agreement covers the product, part or appliance being validated, and remains valid;

Laboratories shall use a validated method that fulfils the performance criteria indicated in Table 3.

Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.

where appropriate, information on validation parameters, in accordance with international guidelines;

Any quantitative, validated, method can be used to measure cell viability.

the method to be applied in routine analysis has to be properly validated.

Detection of non-mutated KRAS expression should be performed by an experienced laboratory using a validated test method.

whereas, in addition, it is essential that these laboratories use validated methods of analysis, whenever possible;

For medicinal products, any new manufacture or important modification of a manufacturing process of a medicinal product shall be validated.

Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.

The information, whether accessible, supplied or included in the report, will be based only on validated data.

All the test procedures shall correspond to the state of scientific progress at the time and shall be validated procedures;

no data may be entered, modified, or validated, except by authorised officials to whom individual passwords are attributed,

Criteria for validating the means by which compliance with the plan will be demonstrated in accordance with criterion 14 and Article 6(2)

Flights outside of this airspace shall entail validation of the permit by the competent authorities of the States concerned.

Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.

Eurocontrol shall provide the civil-aviation user requirements and validate the resulting system in the light of these requirements.

This is the smallest analyte content for which the method has been validated with specified accuracy and precision.

no validated daily average value exceeds the relevant figures set out in part B of Annexes III to VII, and

For the purpose of this Directive, the detection limit specified in the first paragraph should be verified by a validated method of analysis.

For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025:5.4.5) shall be used.

95 % of all the validated hourly average values over the year do not exceed 200 % of the relevant figures set out in part B of Annexes III to VII.

Routine methods must have been validated by operational laboratories, and must fulfil the relevant criteria set out in this Annex.

The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.

It is recommended that the detection of KRAS mutational status be performed by an experienced laboratory using a validated test method.

If convincing evidence of severe effects in well validated in vitro tests is available, a complete test may not be required.

all information entered, modified, or validated, except by authorised officials to whom individual passwords are attributed,