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Cleaning Validation—Lifecycle Approach
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Initiation of Stage 2 Process Qualification is a critical milestone in the cleaning validation. Initiation of Stage 2 Process Qualification implies that the cleaning process has been fully developed. Stage 2 cleaning process performance must confirm the cleaning process development work. When the cleaning validation protocol is prepared, there must be knowledge and understanding of what the critical attributes are, what parameters are directly related to these attributes, what is important to test, why the testing is appropriate, how to do the testing, and what are appropriate acceptance criteria. There must be good confidence that validation tests will meet their predetermined acceptance criteria. Process qualification is not research, development, scale-up, determination of the unknown, fine-tuning, optimization, or other exploratory work. The approved cleaning validation protocol must be executed with an expectation of complete success. All validation test results must meet their predetermined acceptance criteria. Cleaning validation must not be initiated unless there is confidence that tests are appropriate, that they can be performed as written in the protocol without any changes, and that test results will be acceptable.
Biomanufacture
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Technical steps are involved in the validation process. First, each piece of equipment, utility, and facility component must undergo installation qualification, a process to confirm that each item was correctly designed, built, and installed. Limits for usage are also confirmed in installation qualification. These are simply operational limits that could not be exceeded during normal operations. For example, instructions and specifications limit the use of a 10 L fermentation vessel to 5–8 L media volume. The next step is operational qualification, a verification process in which the operating ranges of each item are confirmed under operational conditions. Items may be stressed to the farthest ranges of operational performance. For the fermentation vessel, it might be tested, against specifications, three times, with 5, 6.5, and 8 L media volume. In operational qualification, calibration is completed on mechanical or electrical systems, and control systems are shown to work as designed. Process qualification is the third step, in which the manufacturing process is performed, typically three or more times, so as to demonstrate control, consistency, and achievement of specifications. In process qualification, critical systems are stressed to ensure that they function properly at the limits of operating ranges. Two or three successful repetitions are the norms under validation protocols, and each one must meet specifications. Validation is not a one-time endeavor, and critical systems must undergo the process of revalidation at periodic intervals, after market approval. In addition, any significant manufacturing change must be validated.
Current Good Manufacturing Practices
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
During the process qualification stage of process validation, the process design is evaluated to determine if it is capable of reproducible commercial manufacture. This stage has two elements: (1) design of the facility and qualification of the equipment and utilities and (2) process performance qualification. During process qualification, cGMP-compliant procedures must be followed. Successful completion of process qualification is necessary before commercial distribution. Products manufactured during this stage, if acceptable, can be released for distribution.
Two-level process validation approach for medical devices
Published in Journal of Medical Engineering & Technology, 2019
This article extracts the process validation approaches from both industries guidance documents and compares the validation approach similarity and difference between the two industries. Based on this, and in combination with medical device manufacturing process characteristics and science/risk considerations, two-level (i.e., component production level, device assembly level) process validation approach with IQ, OQ, PQ backbone is proposed for medical device mainstream products (e.g., mechanical-based device, electronics-based device, electromechanical-based device) traditional process validation (or Stage 2 – process qualification shown in the FDA Guidance for Industry, Process Validation: General Principles and Practices [3]), which should meet both medical device and pharmaceutical process validation regulatory expectations and save the medical device manufacturer’s time and resources for process validation implementation. In addition, case studies for the two-level process validation approach are provided that can facilitate the understanding of how to utilise the two-level process validation approach.
OQ & PQ protocols development for medical device two-level process validation
Published in Journal of Medical Engineering & Technology, 2019
In medical device industry, process validation is critical to the regulatory compliance and product quality assurance. A medical device can be an instrument, apparatus, appliance, software, implant, reagent, material or other articles, and from syringes and wheelchairs to cardiac pacemakers and medical imaging technologies (e.g., Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-ray machines). Due to a wide range of technologies and applications, medical device manufacturing could involve multiple technical fields, such as chemical, mechanical, electronics, software and their combinations. Except the devices with chemical and software in nature, device mainstream products (e.g., mechanical-based, electromechanical-based) are manufactured in two levels (i.e., component production level, device assembly level) based on their manufacturing order practice. According to the published paper “Two-level Process Validation Approach for Medical Devices” [1], it mentioned that the process validation (or stage 2 - Process Qualification shown in Food and Drug Administration (FDA) Guidance for Industry, Process Validation: General Principles and Practices [2], or traditional process validation) approach should align with the manufacturing order practice and be divided into two levels including device component production level process validation and final device assembly level process validation. For each level’s process validation, it should have Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as the validation framework, which can be further divided into Equipment Validation IQ, OQ, PQ and Process Validation PQ. Equipment validation PQ is an option depending on equipment quality risk, validation financial risk, and machine design and development activities. Process Validation PQ is mandatory, which is aimed at the performance test of the manufacturing process as a whole under the regular production environment, and is equivalent to stage 2 - Process Performance Qualification (PPQ) shown in the FDA process validation guidance [2]. This two-level process validation approach is the base for the subject article to develop OQ, PQ protocols.