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CHAPTER 6 QUALITY CONTROL
Source: ec.europa.eu
Topic: Quality Control
Sort Desciption: Quality Control is concerned with sampling specifications and testing as well as the ... The independence of Quality Control from Production is considered ...
Content Inside: CHAPTER 6 QUALITY CONTROL Principle Quality Control is concerned with sampling specifications and testing as well as the organisation documentation and release procedures which ensure that the necessary and relevant tests are carried out and that materials are not released for use nor products released for sale or supply until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from Production is considered fundamental to the satisfactory operation of Quality Control. (see also Chapter 1). General 6.1 Each holder of a manufacturing authorisation should have a Quality Control Department. This department should be independent from other departments and under the authority of a person with appropriate qualifications and experience who has one or several control laboratories at his disposal. Adequate resources must be available to ensure that all the Quality Control arrangements are effectively and reliably carried out. 6.2 The principal duties of the head of Quality Control are summarised in Chapter 2. The Quality Control Department as a whole will also have other duties such as to establish validate and implement all quality control procedures keep the reference samples of materials and products ensure the correct labelling of containers of materials and products ensure the monitoring of the stability of the products participate in the investigation of complaints related to the quality of the product etc. All these operations should be carried out in accordance with written procedures and where necessary recorded. 6.3 Finished product assessment should embrace all relevant factors including production conditions results of in-process testing a review of manufacturing (including packaging) documentation compliance with Finished Product Specification and examination of the final finished p ...
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