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.
Project Management and 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.
We at P³ keep high standards.
We have developed a variety of standardized templates for possible challenges and procedures encountered during a multitude of projects.
Please contact us for solutions!