Validation Technology in the Pharmaceutical Industry - A Review
Journal Title: Journal of Drug Discovery and Development - Year 2018, Vol 2, Issue 1
Abstract
Validation Master Plan is expected to serve as a guidance document for deciding the course of various actions and strategies for equipment acquisition, calibration of instruments, qualifications of equipment, system and other validation activities like personnel training and qualification, process, cleaning , analytical method validation, change control, risk analysis and key acceptance criteria, documentation so as to ensure the compliance of state of validation, thereby achieving the corporate quality objectives as well as the compliance of the cGMP regulations and guidelines.3,4,11,14Validation Master Plan is expected to help management to evaluate what the validation program involves with respect to time, people, and financial resources, and to understand the necessity for the program, all members of the validation team to know their tasks and responsibilities and inspectors/auditors to understand the company’s approach and commitment towards validation and the setup of an organization of all validation activities.1,2,3,5The Validation Master Plan shall be a live documentthatis expected to serve throughout the lifecycle of a project and the products, processes, methods and to some extent in case of inclusion of new products, processes, systems, methods and when new project is planned in the existing locations.4,5However, there is always a scope for continuous development in validation approach and execution in a highly regulated industry like finished pharmaceutical products manufacturing, resulting from changes in regulations, environmental/pollution control boards, food and drug authorities’ guidelines and guidance. In such cases the Validation Master Plan shall be modified to maintain its live document status.5And also whenever required separate validation master plans shall be prepared and effected for big projects and specialized validation requirements in line with the principles, approach and philosophy of this Validation Master Plan.4Validation shall be a phenomenon encompassing all the organized effort of all activities, which shall be characterized by tangible deliverables like validation documentation, qualified personnel and well-maintained machine/system resources and the output of validation shall be the quality of the final product
Authors and Affiliations
Anupam Gulabdhar Pandey
Keywords
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