gempex GmbH services

As much as necessary but as little as possible, this credo means that the actual situation has to analysed very carefully so that the essentials are recognized and actions planned according to their importance. Our Offer We provide and prepare: An analysis of the current situation (GMP mock inspection), A definition of the requirements (GMP profile), An action catalogue, A project plan (priorities and time schedule).

Knowledge is the basis for the successful realization of GMP requirements `Knowledge without experience is only a dead load` (Mosché Feldenkrais) Take advantage of our knowledge and our long years of experience.

In the construction or restructuring of chemical and pharmaceutical production plants, GMP starts at the very beginning of the design phase. Our Offer Take advantage of our many years of experience in: User Requirement Specification (URS), Plant concepts, Selection and evaluation of plant components, CIP / SIP technology, Clean-room technology, Water producing plants, And much more. Together with you and our engineering partners we define the procedure to reach `integrated plant qualification` at the beginning of each new construction or restructuring project. The main focus is on the adaptation to standard engineering procedures as well as to your specific procedures to make the work as efficient and cost effective as possible.

A chain is only as strong as its weakest link - this is especially true for very complex plant that consists of many individual and high-quality parts. This is why the qualified manufacturing of those parts is so important.

Adapted to individual targets, individual requirements and the scope of the project

To define what is really important and critical and to reduce the amount of effort to a minimum. Our Offer Preparation, moderation and documentation of risk analyses according to: HACCP, HAZOP, FMEA, Failure Tree Analysis, And others. A risk analysis is a very important instrument in reducing the amount of work in qualification and validation processes to a minimum and directing new or re-construction activities towards the given target in accordance with given requirements.

`Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.`

As documented evidence that computer-supported systems were correctly specified under consideration of the regulatory requirements, were correctly implemented and installed according to their specification and fulfil all requirements for their productive operation.

As an essential element required by GMP to maintain the production plant in a qualified status and to increase its availability. Our Offer Consulting, staffing support and the execution of: Maintenance concepts, Maintenance protocols and reports, Maintenance Procedures (SOPs), Computer-aided maintenance.