Creation and/or updating of SOPs such as release for sale, verification, complaints, recalls  


In February 2019, serialization became mandatory and this does not just involve, for example, the generation of serial numbers and testing or decomission in the German or European database.

Many other processes in the GDP area or in your pharmaceutical company are also linked to this, such as dealing with complaints, recalls or contracts. This also includes training in recognizing counterfeits.

We offer qualified, independent advice and hands-on support in setting up, updating your QM system and implementing it based on internal company processes, current requirements and your products.

These include:

  • Professional recording of your entrepreneurial and QM situation
  • Advice and support in selecting the appropriate serialization software
  • Creation and/or updating of your SOPs such as batch traceability, release for sale, verification, recalls
  • Implementation and training of processes according to the organizational requirements
  • Upload or write off serial numbers in the order
  • Supplier Qualification
  • Implementation of projects to improve the QM system / GxP processes
  • Compliance monitoring
  • Processing of complaints