Top Tips for Pharmaceutical Automation and Validation

Automation is generally considered as a risky subject because of the specialized and technical nature of work. If there is no understanding of how automation is made and designed, it will be very uncompromising to develop an automation system validation strategy. Several studies of software projects have recorded success rates of less than thirty percent, where it was measured based on the schedule, meeting cost estimates, and satisfying requirements.

There are many ways to do automation projects poorly, but just a few ways to do them correctly. The availability of enhanced software tools and techniques makes it visible and testable for the application to the mainstream of the project. This article focuses on new practices and tools to reduce the complexity of the process.
Structure of Automation Projects

Pharmaceutical automation is tough, but when successful, it is very rewarding.

This is the formula for success:

    Meeting schedule milestone and cost estimates;
    Sustaining automation requirements and quality standards;
    Make automation system work right away;
    Satisfying the owners of the business or facilities.

Since, the automated systems will be integrated to the production equipment; this can greatly affect operations, maintenance, profitability, and safety of the finished production facility.

The pharmaceutical industry is regulated by the U.S. Food and Drug Administration (FDA) and the international Ministry of Health. These regulations apply to the manufacturing of drugs and medical devices including the use of computers to manufacture these products.

Since then, the industry’s automation professionals have developed the business processes to support a cradle to grave, life-cycle approach to automation. The industry has had a lot of opportunity over the years to apply business processes to support the delivery of automation.
Beating the Odds

Improve your chances of success with planning, requirements, testing, and documentation. In pharmaceutical automation projects, define and fix your requirements. Have a robust plan, attain management support, and keep the discipline to execute the plan.

There should be organization, consistency, and coordination all throughout the project. Tasks and requirements should be well-defined in the different phases such as design/review, procurement/delivery, and commissioning. Documents are software’s deliverables and these should be specified and given proper resources.

Existing organizations involve in the project such as QA, engineering, maintenance, validation, regulatory affairs and production committees, should be made aware of the scope of their functions and responsibilities. In the later part of the article, we will discuss in detail some techniques and pointers to have a smooth implementation flow.
Conditions Encountered In Project Management

Design specifications should be detailed and complete. Project managers should work hard to complete all information needed. A structured approach that begins with a plan can increase your odds of success. An automation validation master plan defines at a high level the expectations for quality, requirements, testing, documentation, review, and approval. It would also cover expectations for security, change control, maintenance strategy, contingency planning, and periodic reviews.

Since manufacturing facilities are very complicated, design policies should be clearly established recognizing the interest of various stakeholders to attain balance for an efficient operation. The other main part of the plan is to get it approved by the business leaders. In the preliminary planning of a proposed automation upgrade project, controlling cost was identified as the primary issue with getting approval.

For example, the automation team will probably be asked to significantly reduce the estimated cost for the proposed project.  If you have a robust plan, obtain management support, and maintain the discipline to execute the plan, you can achieve your targets. Define the requirements before you start the design, and get the key stakeholders to agree to them. Communicate broadly and keep the requirements fixed during the course of the project design, implementation, and through start-up.
Control Strategy

Along the way, changes cannot be avoided and they would affect the project design, costs, and schedule. A well-established and effective control process is very important. To maximize control, define and fix your requirement.

Accurately define the automation project requirements with the help of the users of the automation system. They should be measurable and testable identifying the industry, tools, and development needs.

Tests should show the expected functionality of the equipment. Comprehensive and quantitative tests should be created in accordance with the actual specifications to achieve their purpose. The success of testing depends, in part, on good requirements. If a process automation professional has solid and fixed requirements, it would be a lot easier. Inappropriate testing will increase cost and extend the development time. Testing reduces start-up issues.

If a developer does too little testing during the development process, there will be mistakes in the process control application code. The software will then have to be fixed later in the development process or during start-up of the manufacturing equipment in the facility. The sooner a designer catches a mistake, the cheaper it is to fix. Appropriate testing can reduce overall project cost and reduce rework during start-up.

Mark Richardson
IT Quality Specialist
Premier Infrastructure