Product development cycle, validation

TABLE II Validation Required at Each Stage of the Product Development Cycle... 

The study of the properties of the lyophilized product collected from various locations within the lyophilizing chamber, according to a predefined sampling plan, is a useful technique, especially in areas such as trouble shooting, product development, cycle optimization, validation of cycle limits, and batch-to-batch consistency. The main purposes of carrying out a mapping of the product within the lyophilizer are the following ... 

Hokanson, G. C., A Life Cycle Approach to the Validation of Analytical Methods During Pharmaceutical Product Development, Part II Changes and the Need for Additional Validation, Pfjarm. Tech., 18(16) 92-100, 1994. 

Validation of a new or existing product involves the efforts of scientists at various stages of the product development life cycle. Scientific information... 

As we know, a critical step within the development cycle of any new product or process is the scale-up step. At this particular point, it is very important that adequate communications have occurred between the group responsible for the product development and the group charged with process validation. Actually, in many organizations, the process/product development department shoulders the responsibility for product scale-up and then transfers the technology to manufacturing for product commercialization [6],... 

Hokanson, G. C. A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I The initial validation process. Pharm Tech 118-130 (Sept. 1994). 

One interesting issue is the development of disposable systems (and disposable, single-use membranes). Disposable systems may become attractive for production processes, because they eliminate the need for development and validation of cleaning cycles. In this case, the development of biodegradable membranes will become an interesting opportunity. 

The equipment hardware and computer software should be developed and validated according to a documented procedure, e.g., according to a product life cycle. The vendor should have a documented and certified quality system, e.g., ISO 9001. Quality must be designed and programmed into software prior to, and during, its development phases by following written develop-... 

Instrument vendors generally react positively to this. For example, most vendors develop and validate analytical products following documented product life cycles. Products are shipped with a Declaration of System Validation or similar documents that certify that the specific product was developed and validated following the product life cycle process. Most vendors are also certified for ISO 9001 and some also for ITQS or Ticklt. Some vendors also make further information on development and testing available to the user on special request, and some guarantee accessibility of the source code to regulatory agencies. 

Whereas case study 1 is a good example of work performed early in the product development life cycle, the next case study presented in this chapter is more representative of a study performed much later during the development stage (or even during process/product validation). From a DOE perspective, the only real difference between the two case studies is the number of factors being considered. As case... 

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