PRODUCT QUALITY ASSURANCE

PRODUCT-QUALITY ASSURANCE (MODULE E)

PRODUCT QUALITY ASSURANCE (MODULE E)

PRODUCT QUALITY ASSURANCE FOR LIFTS (module E)

(Product quality assurance)

It is therefore considered an appropriate basis to ensure a proper comparison between the normal value and export price for the same quality and presentation of the product concerned.

the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self- certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation.

or the product quality assurance procedure (Module E) referred to in Annex II (4),

The manufacturer must operate an approved quality system for production, final product inspection and testing as specified in Section 3. He is subject to the checks referred to in Section 4.

'GMP' is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications.

"GMP" is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications.

The term 'good manufacturing practice (GMP)' means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications.

Such technical prescriptions may include quality, performance, safety and dimensions, as well as requirements applicable to the material, product or supply as regards quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling;

The description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product.

(3) In order to ensure the highest possible level of safety for breast implants, notified bodies should, under the full quality assurance system, carry out an examination of the design dossier of the product in accordance with point 4 of Annex II to Directive 93/42/EEC.

Module E: Product quality assurance

EC DECLARATION OF CONFORMITY (Product quality assurance)

(product quality assurance)

the means of monitoring the achievement of the required design and product quality and the effective operation of the quality assurance system.

the means to monitor the achievement of the required design and product quality and the effective operation of the quality assurance system.

The quality assurance system must ensure compliance of the product with the requirements of the Directives that apply to it.

Whereas, in order to ensure that the consumer is supplied with good quality produce, criteria of a high standard should be fixed for each quality grade;

the procedure relating to conformity to type referred to in Annex VI, or - the procedure relating to product quality assurance referred to in Annex VII;

The manufacturer shall take necessary measures to ensure that the manufacturing process follows the principles of quality assurance as appropriate for the products manufactured.

The manufacturer must operate an approved quality system for production, final product inspection and testing as specified in Section 3.

It is therefore considered an appropriate basis to ensure a proper comparison between the normal value and export price for the same quality and presentation of the product concerned.

Whereas in order to ensure the supply of the consumer with good quality produce it is appropriate to provide for more frequent collection of eggs and for stricter quality criteria for eggs marketed as 'extra';

The term "good manufacturing practice (GMP)" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications.

The manufacturer must operate an approved quality assurance system for design, manufacture and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.

Product quality assurance is the procedure whereby the installer of a lift who satisfies Section 2 ensures and declares that the lifts installed are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them.

In order to ensure the highest possible level of safety for breast implants, notified bodies should, under the full quality assurance system, carry out an examination of the design dossier of the product in accordance with point 4 of Annex II to Directive 93/42/EEC.

During the final control of the finished product before its release for sale or distribution or for use in clinical trials, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.

Product quality assurance is the procedure whereby the manufacturer of the safety component who satisfies Section 2 ensures and declares that the safety components are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them and ensures and declares that the safety component will enable a lift to which it is correctly fitted to satisfy the provisions of the Directive.