Validation master plan scope

Project description What is a Validation Master Plan Scope of Validation Master Plan Definition for the term validation Validation team member Validation team responsibility Concept of qualification/validation Fundamentals... 

Scope of Validation Processes Validation Master Plan Validation Protocols and Reports... 

Computer systems that are identified as requiring validation must be included in the site validation master plan. A validation master plan is typically used as a high-level plan for the site or processes and systems that make up the facility GMP operations. The plan should outline the scope of the validation program, controls to be adopted, and how activities are to be conducted, documented, reviewed, approved, and reported. Target completion dates should be included for validation work in each area. 

Statement Validation (Master) Plan X X X X assessment Scope of a Validation Plan need not be limited to one system ... 

Validation Master Plans typically have three main sections. The first section states how the phar-maceutieal or healtheare eompany s own validation philosophy and policy address regulatory GxP requirements. The seeond section defines the scope of validation, identifying which computer system systems require validation. All computer systems whose malfunction could possibly affect... 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

The documents described, namely, System Qualification Procedures (SQPs) and Standard Operating Procedure (SOP) in Figure 1 contain a generic risk assessment for determination of the validation scope and effort on the equipment lyophilizer. They were also used as a generic validation master plan for the project. Management of the project resources, costs, and deadlines was performed with a model created in a standard project planner. 

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