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Documentation and qualification

Documentation
and qualification

In pharmaceutical production, Good Manufacturing Practices (GMP) are essential to guarantee that the manufacturing process is constantly controlled according 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 Pharma, 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:

GMP & GAMP V PROCESS

The qualification documentation can be adapted to the client's specific needs, offering an individual approach.

Dara Pharma's experts can take care of preparing and executing all necessary protocols.

DESIGN PROTOCOLS

  • Qualification Project Plan (QPP)
  • Functional and Design Specifications (FDS)
  • Hardware Design Specifications (HDS)
  • Software Design Specifications (SDS)
  • Risk Assessment (RA)

TEST PROTOCOLS

  • Design Qualification (DQ)
  • Computer System Validation (CSV)
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Installation and Commissioning (IAC)
  • Record of qualification deviations
  • Record of qualification change controls
Dara Pharma good manufacturing practices
Pharma Filling Lines

Documentation package for GMP equipment.

GmP & GAMP V good manufacturing practices

Personalized protocols.