Development Assurance process formal methods

Typically, the first full-scale events are demonstrations. Some scale-up studies may be performed at full scale just before the formal demonstrations are initiated, however. This would be true in those cases in which the results of the development-ranging studies do not provide sufficient confidence or assurance. In addition to providing assurance that the process can be duplicated at full scale, demonstrations provide a platform for operator training, SOP development, laboratory method fine-tuning, equipment cleaning, and most important, site experience with the demonstrated process. It should be noted that most companies are constrained by a budget for product development, which means that they cannot afford doing a battery of demonstrations. 

The preparation of any pharmaceutical product requires controls over the production operations to assure the end result is a product that meets the required quality attributes. The methods utilized for this control are supported by formalized validation studies in which proof of consistency is demonstrated by appropriately designed experiments. The definition of appropriate operating parameters is the primary objective of the development activities and is further confirmed during scale-up to commercial operations. The validation supports that the routine controls applied to the process are appropriate to assure product quality [36], This is typically accomplished in formalized validation activities in which expanded sampling/testing of the product materials is performed to substantiate their uniformity and suitability for use [30],... 

For many of the restart training topics, the initiator, or assessment of need, was the Charlotte Criteria/WISR and other internal and external reviews. Due to the nature of the restart training topics, formal job and task analyses (JTAs) are not required to determine the important elements for training. However, a structured development process is required to assure all important elements are addressed. A systematic method for developing training material, such as a table-top functional analysis, is an acceptable alternative to the formal JTA. 

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