Documentation and qualification

In pharmaceutical production, Good Manufacturing Practices (GMP) are essential to guarantee that the manufacturing process is constantly controlled ac-cording to the quality standards, and the drugs can be used safely.

Therefore, there must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, ensuring clarity and traceability of the product quality data acquisition.

At Dara-Lyo, we defined specific actions to ensure that our document management, which we call GDP (Good Documentation Practices), fulfills this objective.

The document management starts with the client’s specifications (URS) which help us understand the customer’s needs and define the machine’s configuration accordingly. The required machine’s functionality will be tested later during the qualification tests.

The whole process is described in the picture below, showing the comprehensive Qualification Project Plan (QPP) that covers from mechanical assembly to software and control configuration: