The current practice within cGMP-regulated industries is that validations are conducted by teams of people, working cooperatively toward a common goal. Quality-driven organizations have come to recognize the limitations of clearly defined roles, responsibilities, and organizational boundaries and are starting to use multifunctional teams that integrate all stakeholders’ efforts toward a validation project.
The FDA defines process validation “as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
The following is an interview with Edgar E. Arvelo Garcia, QA validation manager for Pilgrim Software and an expert in project management and building multi-functional validation teams.
Question: What’s it take to have a successful validation program?
It reallydepends upon the information and knowledge from product and process development. Manufacturers need to understand the sources of variation, detect the presence and degree of variation, and understand the impact of variation on the process and ultimately on product attributes. It’s also important to control the variation in a manner commensurate with the risk it represents to the process and product.
You recommend taking an integrated team approach to validation — how does that work?
An integrated approach means the validation team consists of people from different disciplines. For example, team members could have expertise in quality assurance, engineering, manufacturing, laboratory testing, technical services, R&D, clinical engineering, purchasing, and regulatory affairs. The validation project team is assembled for a specific validation project, with members coming from all departments that are affected by that project. For each team member, a back-up is identified to mitigate the risk of unavailability of core members.
What are the responsibilities of the validation team?
Team members define, plan, assess risk, evaluate intended use and execute, document, review, and approve the validation efforts. Tasks include defining protocols of individual validation projects, conducting validation work, reporting and documenting preparation and control, approving/authorizing validation protocols and reports in all stages of validation processes, tracking the system for reference and review, and training when needed.
Is it easy for the validation team to stray off course or lose momentum with all the other responsibilities team members have?
That can definitely be a challenge! Systematic and planned communication between all members of the project team is essential throughout the validation. The schedule identifies specific milestones that can be used to quickly assess the status of the project. The team should also include a risk analysis with each review of the project.
During the validation process audits should be conducted at critical milestones such as test protocols, configuration management processes, and test documentation. Plans have to be flexible and reflect the actual efforts for the project. As the project progresses, plans should be re-evaluated to assure compliance.
One of the most critical aspects of process design and analysis is data flow between process activities. How do you keep it going?
The key requirement of any data flow mechanism in a project is managing the data that is needed as input and provided as output from activities in the project. The data must be provided by an activity in the project that is available to other activities in the workflow that need it. Also provide mechanisms to ensure consistent flow of data from one activity to another.
Senior management support is always critical for success—any suggestions on how to get leadership to “buy in”?
I’d recommend establishing a project charter. It’s basically a statement of the scope, objectives, and participants in the validation project team. It provides a preliminary delineation of roles and responsibilities, outlines the project objectives, identifies the main stakeholders, and defines the authority of the project manager. It is considered industry best practice.
Make sure the project charter documents:
- Reasons for undertaking the project
- Objectives and constraints of the project
- Identities of the main stakeholders
- In-scope and out-of-scope items
- High-level risk management plan
- Communication plan
- Target project benefits
- High-level budget and spending authority