Control of the Manufacturing Environment and Process
The objectives of control of the manufacturing environment are to ensure the quality and consistency of products that are made and that they conform to the approved design. Failure of quality control procedures can occur with any product, and problems arise relatively frequently over standards of preparation of food, where there are so many locations involved. Particular packing materials have sometimes been recognized as giving rise to safety concerns. The result is that it is rare for manufacturing quality defects to arise in relation to medicinal products. The need to control manufacturing processes so as to ensure consistency is self-recommending for all utility products that are engineered or comprise chemical substances, so it may be questioned why this is not a requirement for all product sectors. The New Approach model shows that a variable approach can be achieved that may not overload small manufacturers.
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