Validating the Validators

By Magaly Vega, Professor, Puerto Rico Polytechnic University; José Correa, Taratec Development Corp.; and Ivan Lugo, Executive Director, INDUNIV Research Consortium

PharmaManufacturing.com

Puerto Rico’s Validation Academy and Certification Program bridges the gap between knowledge and experience.

The pharmaceutical industry today is challenged by the need to keep up with advances in science and technology, as well as changing regulatory and compliance issues. Success demands highly skilled validation professionals who not only understand the interdependence of multiple technologies, but the complex integration practices required, and their impact on validation. Such skills are especially important with computer systems validation (CSV; see COMPUTER VALIDATION sidebar below).

To address the need for ongoing training in validation, many scientific and engineering professional associations, such as ISPE, have developed programs designed to ensure competence in key areas of practice. Within Puerto Rico, industry leaders have gone one step further, by establishing a “Validation Academy” within the Polytechnic University of Puerto Rico’s Continuing Education Department. After pilots, the program was officially launched on January 1.

Faculty within the University, concerned consultants and professionals within the industry believe that this program will be essential to fostering the professional growth of validation professionals. The program should also help validation specialists document their specific areas of expertise and sharpen their skills through additional education and training.

Certification as a Validation Professional is voluntary. However, as validation activities become more critical, we believe that more pharmaceutical companies will encourage their validation professionals to pursue certification.

The program will recognize professionals who meet basic eligibility requirements and demonstrate a minimal level of job-related knowledge and skills, based on performance in a standardized examination. To be eligible, one must have a bachelor’s degree in science and three years of experience in pharmaceutical industry validation. For individuals with a significant amount of validation experience, a “grandfather clause” applies, allowing them to receive certification simply by passing a formal examination. (Editor's Note: What's your validation IQ? Test yourself by answering the four sample questions (provided at the end of this article) from a test developed as part of Puerto Rico Polytechnic’s new certification program. The answers may be found by clicking here.)

Faculty members — expert consultants and industry professionals — have identified areas of competency and the knowledge and skills required for each one, and have written test questions targeting these areas. Certification candidates might be asked to:

• Develop a list of User Requirements for a given scenario;
  
  
• Develop test scripts for a given source code;
  
  
• Use data provided to develop a Traceability Matrix.

Each test gives professionals an opportunity to demonstrate their understanding of the variety of industry standards, protocols and technologies, and how to apply them to specific situations (see table below).

Validation Academy Curriculum Modules	General Concepts Module Topics
1. General Concepts	1. Basic Validation Concepts and Documentation
2. Computer Systems	2. Qualification Studies: Facilities, Utilities & Equipment
3. Pharmaceutical Process Technology: Solids	3. Regulatory Trends
4. Pharmaceutical Process Technology: Parenterals	4. Supplier Certification
5. Validation of Analytical Methods	5. Risk Management
6. Biotechnology	6. Cleaning Validation
7. Medical Devices	7. Statistical and Validation Matrix Approach Topics
8. Packaging

After completing a General Concepts module, applicants must complete a specialized module of their choice, and their associated examinations for certification as a validation specialist. Once an individual has completed all eight modules within the course, and their associated exams, they will receive a Validation Professional certificate.

The University will issue certification for a three-year period, and those receiving certification will need to keep up to date on new developments within the field, and build competency through continuing education. Every three years, certified professionals will have to take courses adding up to 14 “Recertification Units” in order to be recertified.


COMPUTER VALIDATION

One of the specialized programs within the Validation Academy will cover computer validation, where there is a great need for certification today. In the past, IT professionals received training while in college on the formal methodologies used to test software. Later, some of these techniques would find their way into a field now officially known as “Computer Systems Validation” (CSV). As technology replaced manual processes, the pharmaceutical industry realized that it needed to take a different approach to demonstrate regulatory compliance and the formal title “CSV Professional” was born.

Today, most, if not all, manufacturing, testing and business systems are controlled by computerized equipment. These Controlling Systems manage pharmaceutical controlled processes or functions.

Validation is required for controlling systems that contain records that are “created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in FDA regulations.” This requirement originated the need for a professional who could establish evidence and associated documentation to prove that a computerized system:

• Has been developed according to quality software engineering principles;
  
  
• Provides the functional capability required by its users and the regulations, and that it will continue to do so over time.

For example, a LIMS (Laboratory Information Management System) is a complex tool used by laboratories within the pharmaceutical, biotechnology and medical device industries. A CSV Professional using the life-cycle approach starts by asking:

• What do we want the LIMS system to do?
  
  
• Are we using the system to receive product?
  
  
• Are we connecting the system to other analytical equipment?
  
  
• What reports or certificates of analysis will the system generate?

By developing User Requirements, the CSV Professional provides the company the information needed to understand and specify the system that best suits the operation, and any and all emotion is removed from the decisionmaking process.

Software testing also requires someone capable of understanding the business, the application and computer validation. Testing (as defined by IEEE and adopted by FDA) is the process of analyzing a software item to detect the differences between existing and required conditions, i.e. bugs, and to evaluate the features of the software.

Today’s computer systems control the precise dispensing of a liquid ingredient, the air flow to a sterile area, the administration of samples in a lab and the highly sophisticated supply management handled by an ERP system. An undetected malfunction in a critical system could lead to loss of product, compliance issues, poor quality and damaging consequences to the business.

The CSV Professional should be proficient enough to create a Test Plan that captures the strategy, requirements, testing environment, acceptance criteria, responsibilities and schedule. The individual should have competencies to assess testing performed at the software development stage. These tests should be traced back to user requirements and specifications. A few questions to ask are: Has the logic flow of the software been tested? Has the software been challenged for dead code? Does the software coding follow a structured approach? Did the developers perform a source code testing (White Box) or a functionality test of the executable run code (Black Box)?

A critical mistake is to assume that computer system validation is an on-off event, when in reality it is an ongoing life cycle. A certification program has the benefits of providing a continuous flow of up-to-date information covering best practices in computer system validation. As technology evolves, we can ensure a workforce that keeps pace with advances.