Regulatory / Validation

The validation phase, strictly speaking, should be conducted throughout the project and is not in any event a

static phase.

The pharmaceutical regulatory compliance , the rules and the standards appropriate forth food – processing

 industry , all these recommendations , good manufacturing  practices and standards are applicable from the

birth of your project. 

The Mill Farma consultant will help you in your regulatory steps, with requirement and responsibility.

- Validation Master plan,

- Quality insurance Plan,

- Quality Project Plan,

- Assistance to certifications FDA, ISO,

- Standard Operating Procedures ( SOP)

But also in all the Quality Project Phases, from the Conception Qualification Phase Management to

the Validation Report Redaction,

- Design Qualification (DQ),

- Factory Acceptance Tests (FAT),

- Pre-Commissioning / Commissioning,

- Site Acceptance Tests (SAT),

- Installation Qualification (IQ),

- Operational Qualification (OQ),

- Assistance to Performance Qualification (PQ),

The validation of the appropriate documentation is performed at every project phase. Therefore,

all operation and procedure guidelines are based on the cGMP (current Good Manufacturing Practices) and

FDA (Food and Drug Administration) initiative.