Yesterday the suit still fit, half a year later it surprisingly has become too tight. Change. Faster and faster. Where barely one change used to be seen in the regulatory environment per year, it is almost impossible to follow today. Requirements keep getting more complex, and not only on the part of authorities. Customers are demanding higher standards as well and competition keeps getting stiffer.
A GMP upgrade is required when a GMP system has not been kept up to date. Or when new processes, new products or new markets demand it. The goal of a GMP upgrade is to make the system state of the art, face the authorities without fear, pass inspections and market products with confidence that they are compliant.
Where Do You Want to Go?
Often it is just a gut feeling. Hearsay but no actual knowledge. Many errors or omissions are known, but how great are the deviations from the specifications and targets really? This is where gempex initially helps establish the objective: what is wanted, what is the goal. Products, processes and markets determine the requirements. They are defined in national and international regulations and laws. The finish line is set.
What is the Starting Point?
Setting goals is followed by establishing the initial position: – what is the current state, and how far away is the goal? This is where a gap analysis provides clarity. gempex experts inspect the condition of rooms, equipment and accessories, review and examine documents, and interview key personnel in the operation. In addition to the current state, they also examine the degree of implementation based on the existing records: to what extent is the system currently being practised?
Changing a Wheel at Full Speed – Without Crashing
The gap analysis lays the foundation for the upgrade, identifies the gaps or what is lacking, establishes priorities and defines measures, to-dos. On this basis, gempex develops a master plan that is submitted for approval to determine the next steps. It also forms the basis for the economic evaluation of the GMP upgrade. The Management is required here. Then comes the challenge: support for the implementation during running operation. Ongoing production has to be maintained, even during protracted conversion or upgrade measures. Here gempex has the required concepts on hand and is familiar with implementing additional activities such as backup measures and the corresponding records. Thus the risk of quality deviations and non-compliance can be excluded as the reliability of existing GMP operations is assured.
When Resources are Lacking
Often there is little time for the upgrade or adaptation and the required resources are frequently lacking. This is where gempex not only provides support in the form of knowledge and competence, but also with helping hands – or a combination if desired. Onsite Execution, consultancy and project execution. The full service offer. Making the upgrade bearable, fast and compliant.
- clear and definite target setting by experts
- complete gap analysis to evaluate the current state
- master plan for decision makers and to plan the next steps
- proven concepts for implementation in the course of ongoing during running operation
- support with know-how and execution
- pragmatic solutions in compliance with regulations