China
Africa
Explore chapters and articles related to this topic
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.
Commissioning, Qualification, and Validation
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
By the end of the 1970s, validation was largely a regulatory exercise that remained isolated from the rest of the firm and was certainly not an area of high concern during the design phase of a project. In 1987, the FDA published its “Guideline on General Principles of Process Validation” [6]. While there was initial opposition to the guideline’s tone, there was general consensus that validation was now a way of life for the pharmaceutical industry. Within the guideline, the FDA provided the following definition that clarified expectations: “Process validation is a documented program which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes” [6].
Validation of Lyophilization
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Definitions for validation published in section 210.3 the Federal Register in May 1996 emphasize the distinctions between process validation and suitability (14). Process validation is defined as “establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.” Process suitability is described as “established capacity of the manufacturing process to produce effective and reproducible results consistently.” Section 211.220, describing process validation also includes demonstrating reproducibility of the process as a requirement.
Two-level process validation approach for medical devices
Published in Journal of Medical Engineering & Technology, 2019
While compared with medical device process validation guidance (GHTF/SG3/N99-10, Quality Management Systems) [1], pharmaceutical process validation guidance documents are much more specific, clear and complete, indicating solid ways on how to conduct process validation for pharmaceutical products. In the definition of validation in 21 CFR Part 820, Section 820.3 (1) “Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications”, and this concept is shared with traditional process validation in the pharmaceutical industry. Both medical device and pharmaceutical products are for health care use and under the same regulatory agency supervision, therefore, it would be better if medical device process validation approach is aligned with the pharmaceutical process validation guidance documents. However, since medical device manufacturing technologies/processes are more mechanical in nature, while pharmaceutical ones are chemical in nature, copying pharmaceutical validation guidance content and used in medical device process validation exercises should be very careful. The article “Medical Device Process Validation: What We Can Borrow from Pharmaceutical Process Validation Guidance” [2] provides some of the answers.
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
GAMP5 (Good Automated Manufacturing Practice 5) was developed by Labman System (2013) to validate vial filling system for the production process. This framework contributes user requirements specification, functional specifications, hard ware and software design specifications. Process validation framework by Khushboo et al. (2014) offers six validation steps which are planning, installation qualification, operational qualification and product qualification to confirm whether the product specifications meet the acceptance criteria, on-going monitoring of product quality and revalidation if any deviation is found in the product specifications.