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[Music] purpose of process validation in pharmaceuticals the kind of effort expended for process validation is largely determined by organizational structure whether process validation is managed by a department a consultant or a committee the criteria for the program are still the same these criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study the following questions are recommended in developing a suitable validation protocol or plan one what is being validated the answer to this question as important because it is essential that the objectives of the validation activity be clearly stated this understanding will enable the responsible group to plan the protocol and the test program needed to carry out the validation program quality assurance requires that the total process validation document include the following data on the iq for the facility and equipment data on the oq for the facility and equip