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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.
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 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.
Stencils are the basis for many algorithms to numerically solve partial differential equations (PDE). Two examples of stencils are the five-point stencil and the Crank–Nicolson method stencil. Stencils are classified into two categories: compact and non-compact, the difference being the layers from the point of interest that are also used for ...
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 ]
Data reconciliation is a technique that targets at correcting measurement errors that are due to measurement noise, i.e. random errors.From a statistical point of view the main assumption is that no systematic errors exist in the set of measurements, since they may bias the reconciliation results and reduce the robustness of the reconciliation.