As with all validation life-cycle documents, a validation master plan is a formal document produced by the pharmaceutical manufacturer. The plan should require that all validation documentation is under a strict document control procedure with issue and revision of documents controlled by means of an approval tables, identifying the name, signature, date, and level of authority of the signatory.
A validation master plan should describe the purpose and level of the plan and must be consistent with established policies and the GMP risk and criticality analysis. The document must be approved and state the period after which the plan is to be reviewed.
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.
It should address and identify procedures for:
- Validation strategy (including reference to the respective regulations)
- Structure, reference/naming conventions
- Location of validation documentation
- Description of the facility, products, operations, process equipment
- Computer system register
- Validation evaluation and rationale
- Validation program priorities
- Justification for non-validated systems
- Validation organisation/responsibilities
- Validation training
- Ongoing evaluation, periodic review intervals
- Use of validation project plans
- Support programs and procedures
- Reference documents and definitions
The plan should be reviewed annually (as a minimum) to ensure and record that it is current and that progress is being made against the plan.
Validation Master Plans Vs Project Validation Plans
The project validation plan is for individual projects (including equipment) or systems and is derived from the validation master plan. The project validation plan should be closely linked to the overall project and quality plan.
The validation plan should put forward a reasoned, logical case that completion of the defined activities will be sufficient to deliver the documented evidence that will provide a high degree of assurance that a computer system will consistently meet its predetermined specifications.
A project – or system-specific validation plan should address the following in sufficient detail to form the basis for reporting the validation program:
- Description of process/environment
- Quality related critical parameters
- Purpose and objectives of the system
- Major benefits of the system
- Special requirements
- Specific training needs
- System operating strategy
- Related GMP compliance/regulations
- Physical and logical boundaries
- System GMP risk assessment
- System validation rationale
- Life-cycle documentation
- Assumptions and prerequisites
- Limitations and exclusions
- Quality-related critical parameters/data
- Standard operating procedures
- System requirement specification
- Supplier and system history
- Vendor evaluations and audits
- System design, development, build
- Software review
- Qualifications (DQ, IQ, OQ and PQ)
- Qualification and validation reports
- Ongoing evaluation
- Problem reporting/resolution
- Operational plans
- Validation file
- Internal audits
- Support programs/procedures
- Reference documents
- Authorities/responsibilities
- Resource plan and target end dates
Live Document
The project plan is a live document that should be reviewed against each life-cycle step and any other validation milestones (as a minimum). Any changes to the plan should be identified on a revision history section within the document. The plan should be retained in the validation file and should be easily accessible.
The Team
For each system validation project the validation team must be identified and would typically consist of designated personnel (normally identified by job function at this stage) that will be responsible for the provision, review, and approval of all validation documents and implementation of the qualification testing.
As applicable, the project engineering contractor and the system supplier/integrator can expect to participate on the project validation team at the appropriate time. The purchasing/contracts groups may also be involved and play a key role in administering contractual validation activities and documentation.
Computer System
In the case of a computer system applied to a live manufacturing process and integral with plant equipment and this process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerised operation are sometimes combined.
Execution of the project validation plan will provide control and full documentation of the validation.
If you have experience developing master or project plans please feel free to offer your 2 cents below.
