Anyone who has read them knows: GMP rules are general, openly worded and leave room for interpretation. Direct 1 to 1 implementation is not possible. This is exactly where the uncertainty of many customers begins: What sets of standards are relevant? What is mandatory, what is optional? How does a requirement have to be implemented? What approach has to be chosen, when is documentation required? Which internal departments are affected, what needs to be reviewed and when? One thing is certain: GMP for a chemical plant is different than GMP for sterile pharmaceutical production. And this in turn is different from GMP for a modern biotech plant. Competent consultancy is required here. Routined expertise, with an eye for specifics and a combination of knowledge and experience!
GMP Compliance as the Top Commandment
Consulting projects aim to quickly achieve guaranteed compliance with the GMP rules. After all, deficiencies in quality assurance can have more than just consequences for product quality and consumer protection. If a product does not go to market in time because compliance is lacking, the economic damage is massive. This is where gempex consultants not only offer established GMP experience. They have also accompanied, prepared for and followed up on numerous official inspections and audits. Therefore they know exactly what is needed and can interpret the GMP rules reliably.
Feasibility is the Key – Consultancy Based on Practice
The best consultancy is no good if the proposed solutions are theoretical, far removed from practice, and ultimately cannot be implemented due to a lack of feasibility. Since gempex itself is involved in the implementation of GMP solutions, customers can be certain that the proposed solutions and concepts are practice-oriented, pragmatic and feasible.
As Much as Necessary, as Little as Possible
Who hasn’t experienced this? The fear that consultants recommend the maximum just to be on the safe side. There is no such fear with gempex. A business management understanding plays an important role in consulting. The gempex experts are very much aware: economic efficiency is an important element in addition to compliance and feasibility! Even more so when it comes to low-cost products in large-scale quantities. Efficient, sustainable and safe solutions are designed with a clear view of regulatory requirements. Customer consultancy is provided on this basis.
The Right Consultancy at the Right Time
gempex offers numerous options for consulting support. Ultimately it depends on the task and the requirements resulting from product, process and the current project. Fundamentally the following are offered:
- compliance consultancy for general GMP questions
- concept consultancy for validation, documentation or integrated GMP concepts
- specialised consultancy for specific issues, for instance related to inspections
- consulting support by “looking over the shoulder” during the implementation of GMP measures
- overview of GMP rules and their requirements
- solution approaches to meet individual requirements
- tailored precisely to the product, process and project
- pragmatic and focused on actual needs
- consultants with established expertise, knowledge of regulations and years of practical experience
- flexible regarding time and scope
- consultancy based on partnership with a view of economic efficiency