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 Regulatory Requirement and Step for Registration and Approval of Indian Drug Products in Overseas Market

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Rushikesh Aher ◽  
Pratik Aher ◽  
Tejas Ahire ◽  
Hitesh V. Shahare ◽  
Charulata T. Nemade
Keyword(s):  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Raw Material ◽  
Critical Parameters ◽  
Material Base ◽  
Technical Documentation ◽  
Regulatory Requirement ◽  
Drug Products ◽  
The World ◽  
Overseas Market

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.

Application of Chitosan in Veterinary Vaccine Production

2018 ◽  
Vol 54 (5) ◽  
pp. 518-521 ◽  
Author(s):  
A. I. Albulov ◽  
M. A. Frolova ◽  
A. V. Grin ◽  
E. I. Kovaleva ◽  
N. V. Melnik ◽  
...  
Keyword(s):  
Vaccine Production ◽  
Veterinary Vaccine

scholarly journals Veterinary vaccine production using bioreactors: scale up study from laboratory and pd up to commercial production

2015 ◽  
Vol 9 (S9) ◽  
Author(s):  
Lídia Garcia ◽  
Maria Turon ◽  
Marta Comellas ◽  
Mercedes Mouriño ◽  
Alicia Urniza
Keyword(s):  
Scale Up ◽  
Commercial Production ◽  
Vaccine Production ◽  
Veterinary Vaccine ◽  
Scale Up Study

Novel Methodology for Inherent Safety Assessment in the Process Design Stage

2013 ◽  
Vol 52 (17) ◽  
pp. 5921-5933 ◽  
Author(s):  
Preeti Gangadharan ◽  
Ravinder Singh ◽  
Fangqin Cheng ◽  
Helen H. Lou
Keyword(s):  
Process Design ◽  
Safety Assessment ◽  
Design Stage ◽  
Inherent Safety

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.

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