FDA/GMP validations -
the fast, competent and pragmatic way!

Individual, efficient methods for implementing FDA regulations

The Challenge:
Before pharmaceutical products are approved in the United States, they must first fulfill the strict regulations of the Food and Drug Administration (FDA). All systems that are used in producing pharmaceutical products for the U.S. market, therefore, must first be validated and receive FDA/GMP approval. Within Europe, the European Medicinal Evaluation Agency (EMEA) serves as the sole authority among all EU member states for granting and/or revoking the approval for all drugs or genetically engineered substances.

These requirements affect pharmaceutical manufacturers, clinical research companies as well as the producers of raw materials and additives for the pharmaceutical industry. If regulatory officials discover any violations against these requirements during an inspection, they could charge these companies fines or, in extreme cases, even force them to close production facilities or suspend their approval entirely.

Measures:
The validation creates the documented proof that all processes and systems which influence product quality fulfill the requirements specified by the FDA.

As a result, your company achieves:

• FDA/GMP compliance as well as added security during audits and in legal matters
• Documented quality of the entire development and production lifecycle
• Investment security for your products
  

Our offerings:
Alegri's validation consulting (which includes GAMP 5® requirements) provides a pragmatic approach to attain, maintain and continuously adapt compliance requirements for computer-based systems in laboratories and production centers, clinical data management as well as software development in these areas. Our understanding of a computer-based system includes the hardware, operating system, application as well as the controlled function and supported process itself. Alegri supports the validation of the IT system (including the complete lifecycle documentation) as well as its technical and process-related infrastructure.

Alegri provides all of the services you need to guarantee success:

• Validation workshops
• Professional FDA compliance consulting
• Validation and qualification of processes, infrastructure and systems (including all relevant documents)
• Performing supplier audits
• Implementation and trainings
• Validated system operations

Your advantages:

• Pragmatic validation approaches specifically for your company
• Support in creating qualification plans and validation documents
• Execution of the qualification process
• Execution of risk classifications and analyses
• Preparation and implementation of system audits
• More efficient organization of supplier audits
• Regular monitoring to maintain the validation status of affected systems