Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Creating a Validation Master Plan (VMP) is a guide for successful validation and qualification throughout a facility.
To ensure that a specific piece of equipment or process gives the output desired, the equipment used for the product must be validated. Equipment used for testing or manufacturing must be validated due to the risk it may propose to the product or end-user. Not validating equipment currently used for testing, V&V, manufacturing, and inspection purposes will likely result in a major audit finding, such as an FDA Form 483. The Validation Master Plan is the manufacturer’s roadmap for qualification throughout a facility. It clearly defines the systems which must be validated and details the program the organization sets forth to conduct validation activities.
Effective process validation contributes substantially to assuring a quality product. The basic principle of quality assurance is that a product shall be made to fit its intended use. If there aren’t any controls for validated equipment, then all results and finished goods have no assurance of consistent outcomes. If something ever goes wrong with a product, it would be hard to identify the root cause of the issue if the equipment used for the process does not have proof that it is working as it should and that the outcome of its performance meets the design controls for the product.
The Function of a Validation Master Plan (VMP)
The Validation Master Plan (VMP) is beneficial for planning purposes because it identifies anticipated resource needs and provides key input into scheduling project timelines. It documents the scope of the validation effort, including impacted products, processes, procedures, facilities, equipment, and utilities.
The VMP also includes a schedule that creates specific timetables for when each validation will take place and by whom. The Quality Department, which controls validation activities, defines the impacted functional areas in the document suitably.
Like other master plans, the VMP is a tool for process control. It serves a practical function in instructing personnel on how and why validation activities should be carried out. Furthermore, it serves as a compliance function since it documents the validation program, as required by regulatory agencies for proper process control.
Additionally, the VMP enables stakeholders within the organization to unify around the details of the validation strategy. It eliminates the ambiguity in justifying validation activities, internally within teams and externally for inspectors and auditors. Beyond the frontline, it can be a vital tool for informing and educating upper managers about the importance of validation in terms of its downstream impact on product quality.
A well-crafted Validation Master Plan can be a primary resource in scoping a validation effort to determine impacted products, processes, procedures, facilities, equipment, and utility systems. PSC Biotech® offers outstanding quality assurance services that help a company be ready for an audit. Contact us now for more information about PSC Biotech® consultants for VMPs.
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