Managing projects in GMP

For us, project management means dealing with complexity and constantly changing conditions in a structured manner.

After clarifying the project’s targets, risks need to be analyzed, responsibilities determined and work packages defined. Based on that of course, all resources must be planned, as well as deadlines and milestones. Most importantly the decision-making processes must be determined.

GMP Compliance

For projects in the health sector, GMP compliance is an integral part of project management. The relevant GMP topics are therefore integrated into the three PM elements of deadline tracking, costing and quality assurance. This integration takes place in the first project phases at P³ and forms an integral part of all planning and execution phases. Critical issues relating to inspection or the execution of qualification are assessed in the feasibility study and presented as expenditure.

Qualification and validation, as documented proof of suitability (fulfillment of the intended purpose), is one of the pillars for ensuring drug quality and thus patient safety.

The first edition of the German Medicines Act was published in 1976. The first globally valid GMP guidelines followed in 1978. In 1990, the European Commission initiated the so-called ICH program to harmonize international approval standards.