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Why Validation?
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
With this understanding of its dependencies, validation is more easily assimilated into the overall CGMP environment rather than being something apart from it. Although firms will likely have a validation department, it must be supported by activities in other parts of the organization. For example, a poorly developed process performed using uncalibrated equipment making a product that has no standard test methods could never be considered validated. The supportive elements must be properly operated in order to result in a compliant product, and one that can be successfully validated. A later definition that addresses the larger scope of validation within the overall organization appears following: Validation is a defined program which, in combination with routine production methods and quality control techniques, provides documented assurance that a system is performing as intended and/or that a product conforms to its predetermined specifications.5
Sterile Drug Product Process Validation
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Process validation is defined in the 2011 guidance as follows: Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes the process validation activities in three stages: Stage 1—Process Design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.Stage 2—Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.Stage 3—Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Manufacturing Process Validation
Published in Sam A. Hout, Manufacturing of Quality Oral Drug Products, 2022
The objectives of this section are to define requirements for process validation, understand the lifecycle approach to process validation, and describe elements of Stage 1, 2, and 3 of process validation. There are different types of validations, namely critical systems validation, design validation, cleaning validation, sterilization validation, analytical instrument validation, software validation, hardware validation, test method validation, and analytical method validation. Nonetheless, this section is concerned with process validation.
Modelling and sizing techniques to mitigate the impacts of wind fluctuations on power networks: a review
Published in International Journal of Ambient Energy, 2022
M. V. Tejeswini, I. Jacob Raglend
The DFIG modelling is done using the switch averaged loss prediction model and the accuracy of the model is validated with the traditional pulse width modulation switching model and manufacture’s software (Lei et al. 2015). The WT and ESE are modelled using Matlab/Simulink/SimPowerSystems environment. The validation of the model is done using WT emulator and a dSPACE DS1103 real-time board. The hardware scheme is set up using Danfoss VLT FC302 frequency converter. The validation is done by considering different case studies. The obtained results in simulation are approximately equal to the hardware set-up waveform (Barote, Marinescu, and Cirstea 2012). Validation techniques are broadly classified into three categories: Calibrating against detailed equipment models, type test/staged tests and monitoring-based model validation (Asmine et al. 2010). The modelling and validation techniques are listed in Table 7.
A comprehensive validation framework addressing utility parameter validation for application in small and medium enterprises (SMEs):A case study in pharmaceutical industry
Published in Cogent Engineering, 2023
Vothia Surian Subramaniam, Joshua Prakash, Shahrul Kamaruddin, Sze Wei Khoo
Food and Drug Administration (2008) defined validation as a collection and evaluation of data which establishes scientific evidence that an equipment, utility or facility is capable of consistently delivering quality products. In pharmaceutical view, validation referred as a process of establishing documented evidence that manufacturing facility, utility and equipment must be properly installed, functioned and performed in order to support the manufacturing of high-quality pharmaceutical products. Validation is a process of assurance that the specific equipment or system is able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do (Rajinder, 2008).
A taxonomy of validation strategies to ensure the safe operation of highly automated vehicles
Published in Journal of Intelligent Transportation Systems, 2021
Felix Batsch, Stratis Kanarachos, Madeline Cheah, Roberto Ponticelli, Mike Blundell
This section gives an overview over the different validation methods that are used today. In the automotive context, validation assures that the functionality and safety during the intended use of the vehicle can be guaranteed. This is traditionally done by using the staged V-Model validation process as defined in ISO26262 and displayed in Figure 1. The left side of the V-Model represents the design phase and the right side the corresponding hardware tests conducted to validate the design. The test methods range from field operational tests (FOTs), which represent reality as close as possible, to validation in simulation, where the focus is mainly on the software.