Validation master plan
Encyclopedia
The Validation Master Plan also referenced as "VMP" is one of the key documents in the GMP (Good manufacturing practice
) regulated pharmaceutical industry. Even though it is not mandatory the Food and Drug Administration inspectors will ask you for it when they inspect your facility. An inspector can look at the VMP and
realize that the facility's validation strategy is well thought out and organized; that there is a logical
reason for including or excluding every system associated with the validation project
based on a risk assessment. A Validation Master Plan (VMP) drives a structured approach to validation projects that will allow you to address many problems before they become crises. A VMP outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes. The VMP is the foundation for the validation
program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.
Common topics to be covered in a Validation Master Plan:
Introduction, Scope of the VMP, Responsibilities, Description of facility and design, Building and Plant Layout, Construction materials, Cleanliness Zoning and room pressure Concept, Storage Areas, Personnel, Training and Personnel Flow, Material and Waste Flow, Water and solid waste handling, Infrastructure and Utilities, Water qualities, Heating, ventilation and air-conditioning (HVAC)
Clean Steam, compressed air, gases and Vacuum System, Description of Manufacturing Equipment,
Building management systems, Products to be manufactured, Qualification/validation approach,
Process Validation and Cleaning validation
approach, Microbiological Monitoring and Computer Validation, Calibration, Maintenance, Change Control, Suppliers Inspections, Internal audits and other key SOPs.
If a pharmaceutical company within the US wants to pass an FDA audit a process validation master plan, an equipment validation master plan, a cleaning validation master plan and a computer validation master plan are very necessary.
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
) regulated pharmaceutical industry. Even though it is not mandatory the Food and Drug Administration inspectors will ask you for it when they inspect your facility. An inspector can look at the VMP and
realize that the facility's validation strategy is well thought out and organized; that there is a logical
reason for including or excluding every system associated with the validation project
based on a risk assessment. A Validation Master Plan (VMP) drives a structured approach to validation projects that will allow you to address many problems before they become crises. A VMP outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes. The VMP is the foundation for the validation
Validation (drug manufacture)
Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...
program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.
Common topics to be covered in a Validation Master Plan:
Introduction, Scope of the VMP, Responsibilities, Description of facility and design, Building and Plant Layout, Construction materials, Cleanliness Zoning and room pressure Concept, Storage Areas, Personnel, Training and Personnel Flow, Material and Waste Flow, Water and solid waste handling, Infrastructure and Utilities, Water qualities, Heating, ventilation and air-conditioning (HVAC)
Clean Steam, compressed air, gases and Vacuum System, Description of Manufacturing Equipment,
Building management systems, Products to be manufactured, Qualification/validation approach,
Process Validation and Cleaning validation
Cleaning validation
Cleaning validation for is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes...
approach, Microbiological Monitoring and Computer Validation, Calibration, Maintenance, Change Control, Suppliers Inspections, Internal audits and other key SOPs.
If a pharmaceutical company within the US wants to pass an FDA audit a process validation master plan, an equipment validation master plan, a cleaning validation master plan and a computer validation master plan are very necessary.