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The understanding of the authorities' requirements is a prerequisite for correct execution of the specified guidelines.

GMP Implementation in Production

GMP guidelines are the skeleton of each pharma company. Unfortunately, they are often translated into complex manufacturing and documentation instructions difficult to understand and follow.

But: Implementation of GMP Guidelines does not have to be uninspiring. It is important that the employees understand the guidelines and the derived instructions, processes and documentation requirements. Only understood guidelines will be successfully implemented, lived and followed.

We support you to implement clear and simple instructions in your production environment.

Until the 9th February 2019 the falsified medicine directive for prescription drug needs to be implemented. Are you ready?

We can support you due to our experience.

FDA GMP Requirements

FDA does not need to be equivalent with a tedious inspection. 

Do you know the FDA requirements for production?
Are these consequently followed?
Do you know the difference with regard to the European Guidelines?
Do you have the right documents?

When you know the answers to those questions, then FDA readiness might be an important milestone for your company.

We support you in finding the right answers. 

ISO Requirements

The ISO guidelines 2001 and 13485 have significantly changed. Process orientated reasoning and knowledge management needs to be lived.

Anything, that is not written down, has not been done. This is the principle of quality assurance. It is required to describe each individual operation in detail according to the guidelines.

Are your individual operations simple and clearly described?
Do they correspond to the working steps of the employees?
Do your employees know the set operation procedures? Do you know the latest changes of the ISO guidelines and did you already implement them accordingly?

We generate the required documents and SOPs (Standard Operation Procedures) for you and also will take over the training of your co-workers. 

Audit Preparation (ISO/GMP/FDA/EMA)

Are you expecting an authority inspection or customer audit?

We help you before, during and after the next audit/inspection with: 

  • Determination of the need for action doing a pre-audit
  • Establishing an efficient preparation plan
  • Training of the co-workers
  • Attendance during the audit/inspection
  • Definition of adequate measures for correction after the audit based on the audit report