Process Validation Vs Process Qualification - An Overview

2019 ◽  
Vol 67 (7) ◽  
pp. 1-4
Author(s):  
Preeti kulkarni ◽  
Anil Ghule ◽  
Sandip Badadhe
Keyword(s):  
Process Validation ◽  
Process Qualification

Process Qualification for a Mobile Robotic Welding System Through Manipulability

2012 ◽  
Author(s):  
Justin Stacy ◽  
Daniel Langley ◽  
Stephen L. Canfield
Keyword(s):  
Mobile Robot ◽  
Motion Control ◽  
Mobile Robotics ◽  
Welding Process ◽  
Robotic Welding ◽  
Market Place ◽  
Validation Process ◽  
Process Validation ◽  
Process Qualification ◽  
Welding System

Advances in mobile robotics make these systems viable alternatives for developing new methods and techniques for manufacturing processes such as welding. When considering welding as a manufacturing process, the ability of the equipment to conduct the weld process must be verified. This step is called weld process validation and is generally conducted when a new machine or technique is introduced to the weld process. Traditionally, the weld validation process has focused on the electro-thermal aspects of the weld process, while the (human) welder qualification provides a certification step to ensure that an operator can perform the motion-control aspects of the weld operation while welding. The lack of industry standards for mechanized welding makes it difficult to introduce mobile robotic welding systems with validated performance in the market place. This paper will propose one approach to consider the motion control portion of the weld process validation for welding systems based on mobile robotic platforms. In particular, this paper will consider a skid-steer type mobile robot that is able to weld in flat, horizontal and vertical orientations. The paper will consider the motion-control portion of the weld validation process and will suggest a method that compares a mobile-robot-based welding process to a baseline (fixed-base track system) welding process through spanning manipulability ellipses. This approach allows general topologies of a mobile robotic welding system to be considered in a general way as a step to making mobile robotic welding a viable welding process.

scholarly journals Process Validation in Pharmaceutical Product Development: An Overview

2021 ◽  
Vol 10 (5) ◽  
Author(s):  
Sreenivasa.G. M ◽  
Sriranga. T ◽  
Naveen Banakar ◽  
Vaishakha Kori ◽  
Chetankumar Vasanad ◽  
...  
Keyword(s):  
Product Development ◽  
Manufacturing Process ◽  
Process Development ◽  
Pharmaceutical Product ◽  
Product Development Process ◽  
Process Validation ◽  
Pharmaceutical Product Development ◽  
Process Qualification ◽  
Evaluation Of Data ◽  
Required Quality

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity. A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance. Keywords: GMP, Validation, validation manufacturing process.

scholarly journals Process Validation and Critical Regulatory Requirements in Manufacturing of Inactivated Veterinary Vaccines

2018 ◽  
Vol 3 (2) ◽  
Keyword(s):  
Process Design ◽  
Scientific Evidence ◽  
Good Manufacturing Practice ◽  
Critical Parameters ◽  
Design Stage ◽  
Vaccine Production ◽  
Regulatory Requirement ◽  
Process Validation ◽  
Veterinary Vaccine ◽  
Process Qualification

Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.

scholarly journals Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

2021 ◽  
Vol 22 (8) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Best Practices ◽  
Process Design ◽  
Control Charts ◽  
Batch Size ◽  
Drying Time ◽  
Process Validation ◽  
Process Verification ◽  
Process Qualification ◽  
The Impact ◽  
Validation Strategy

Abstract This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

scholarly journals Injectable Hydrogels: From Laboratory to Industrialization

Polymers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 650
Author(s):  
Jose Maria Alonso ◽  
Jon Andrade del Olmo ◽  
Raul Perez Gonzalez ◽  
Virginia Saez-Martinez
Keyword(s):  
Industrial Process ◽  
Functional Materials ◽  
Point Of View ◽  
Industrial Scale ◽  
Injectable Hydrogels ◽  
Safety And Efficacy ◽  
Process Validation ◽  
Characterization Techniques ◽  
Hyaluronic Acid Hydrogel ◽  
Lack Of Knowledge

The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.

Life Cycle Approach to Process Validation

2018 ◽  
pp. 1-7
Author(s):  
Ajay Babu Pazhayattil ◽  
Naheed Sayeed-Desta ◽  
Emilija Fredro-Kumbaradzi ◽  
Jordan Collins
Keyword(s):  
Life Cycle ◽  
Life Cycle Approach ◽  
Process Validation

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPORTANCE AND IMPUTATION

2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
Author(s):  
M Mohankumar ◽  
G Sivakamasundari
Keyword(s):  
Quality Assurance ◽  
Creative Process ◽  
Process Validation ◽  
The Us ◽  
Measurement Control ◽  
Quantitative Validation ◽  
Measurement Validation ◽  
Quality Of Products ◽  
Pharmaceutical Production

Validation is a notable step in fulfilling and keep the character of the last decision. In the event that every progress of the creative process is recognized, we can guarantee that the end result will be of the best quality. Validation is specialized for planning and rehearsing a closely planned step with documents. Verification and quality assurance are inseparable, which guarantees careful quality of products. The process validation underscores the components of the measurement scheme and adheres to the measurement control during commercialization and realizes that it is nothing more than a continuous program and adjust the measurement validation exercises with the item life cycle. The motivation behind this survey is to introduce a presentation and general disclosure on quantitative validation of pharmaceutical production with a unique note to the requirements specified by the US Food and Drug Administration (FDA).

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