It is through careful design and validation of both the process and process controls that a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. was the pioneer in advocating the concept of process validation, but till 29th September 1978 the definition of process validation did not appear in any part of literature of U. As a result, the mission was often managed from within the sterile manufacturing organization using a small team. Process validation involves a series of activities taking place over the lifecycle of the product and validation process as shown in Figure 1. VALIDATION LIFE CYCLE This particular definition did not appear in any of the yearly revision of that particular compliance programmed but until March 29, 1983 it was the only official definition of process validation on March 29, 1983 draft on guidelines entitled “Guidelines on General Principles of Process Validation” was made available and the same was finalized in May, 1987 .
Ittadwar Department of Quality Assurance, Gurunanak College of Pharmacy, Nagpur-440 026, Maharashtra, India ABSTRACT Validation is an integral part of quality assurance; the product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing.
Process design is the first of three stages of process validation.
Data from the development phase is gathered and analyzed to understand end-to-end system processes.
The main advantage is that small amounts of shading, debris or snow lines on any one solar module, or even a complete module failure, do not disproportionately reduce the output of the entire array.
Each microinverter harvests optimum power by performing maximum power point tracking (MPPT) for its connected module.