Search results
Results From The WOW.Com Content Network
Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Method of lines - the example, which shows the origin of the name of method. The method of lines (MOL, NMOL, NUMOL [1] [2] [3]) is a technique for solving partial differential equations (PDEs) in which all but one dimension is discretized.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Characteristics may fail to cover part of the domain of the PDE. This is called a rarefaction, and indicates the solution typically exists only in a weak, i.e. integral equation, sense. The direction of the characteristic lines indicates the flow of values through the solution, as the example above demonstrates.
The discrete difference equations may then be solved iteratively to calculate a price for the option. [4] The approach arises since the evolution of the option value can be modelled via a partial differential equation (PDE), as a function of (at least) time and price of underlying; see for example the Black–Scholes PDE. Once in this form, a ...