Design and development activities

Do the design controls ensure that design and development activities are planned so as prevent failure and secure success ... 

The standard requires that the design and development plans describe or reference design and development activities. Hence where you need to produce separate plans they should be referenced in the overall plan so that you remain in control of all the activities. 

Where are your plans in which you have identified the responsibility for each design and development activity ... 

Approved critical parameters and data are not open to interpretation at any time throughout the system validation life cycle. This is particularly important where design and development activities are not directly controlled by the pharmaceutical manufacturer. 

The documentation for system design and development activities complete with development test results is normally prepared by the supplier. At a minimum, copies of the document reviews and a listing of the application development records should be provided for appending to the pharmaceutical manufacturer s DQ report. The pharmaceutical manufacturer may request copies of the supplier s application development and test records for inclusion in the validation file or arrange for the supplier to maintain and store all system application development records. 

The excipient manufacturer should develop plans that identify the responsibility for each design and development activity which is updated as necessary. Organizational and technical interfaces between different groups should be identified and the necessary information documented, transmitted and regularly reviewed. 

In determining the necessary design and development activities, particular attention should be given to the following topics (paras 3.22-3.27). 

Engineering design is thus seen to embrace a wide spectrum of activities ranging from conceiving new products to sales and service engineering. As we proceed down the above list of design and development activities, work becomes more disciplined and the number of considerations involved increases in scope. It should proceed in an orderly manner from research to application. 

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