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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.
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...
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.
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.
ISO 15927 Hygrothermal performance of buildings – Calculation and presentation of climatic data ISO 15927-1:2003 Part 1: Monthly means of single meteorological elements; ISO 15927-2:2009 Part 2: Hourly data for design cooling load; ISO 15927-3:2009 Part 3: Calculation of a driving rain index for vertical surfaces from hourly wind and rain data
A check sheet is a form (document) used to collect data in real time at the location where the data is generated. The data it captures can be quantitative or qualitative.When the information is quantitative, the check sheet is sometimes called a tally sheet.
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.
A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long-term trend analysis as well as intra-production quality analysis.
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