Validation Master Plan (VMP) describes the company’s intentions regarding the validation of equipments, instruments, systems, utilities, facilities, materials, analytical methods and processes.
Validation Master Plan, being a dynamic document, presents a current overview of the entire validation activities, its organizational structure and planning for the current year.
Validation Master Plan ensures that:
VMP adds value to our quality system and provides assurance on the product quality, by ensuring that our facility, equipment and processes remain in a state of validation.
A suitable validation program is designed, in order to demonstrate that the facility is capable of meeting process / product parameters in a repeatable and controllable manner.
The facility is designed to provide the desired degree of environment controls as well as manufacturing controls, for all the production steps and throughout the manufacturing process of the Pharmaceutical Products.
The critical programs for utilities qualification, process validation and equipment qualification have been established, in accordance with the product requirements (based on the product information and the cGMP guidelines and other regulations).
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TABLE OF CONTENTS
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TABLE OF CONTENTS
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APPROVAL
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GENERAL INFORMATION
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TABLE OF CONTENTS
VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN
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RESPONSIBILITY
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RESPONSIBILITY
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RESPONSIBILITY
VALIDATION DOCUMENTS
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VALIDATION DOCUMENTS
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VALIDATION DOCUMENTS
AREA QUALIFICATION APPROACH
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AREA QUALIFICATION APPROACH
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AREA QUALIFICATION APPROACH
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QUALIFICATION APPROACH
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QUALIFICATION APPROACH
EQUIPMENT QUALIFICATION APPROACH
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EQUIPMENT QUALIFICATION APPROACH
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EQUIPMENT QUALIFICATION APPROACH
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