customized solution
of production process tracking


According to the Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients and based on the guidelines of PIC/S Guide  to Good Practices for the Preparation of medicinal products in healthcare establishments, we decided that it was of the utmost importance to invest in a reliable and expandable software platform.

We developed a novel software solution capable of fully monitoring all  laboratory processes, from the ordering and handover protocol of raw materials, to the release of the final product and delivery to the patient.

This was made possible by customizing EPSILON SINGULARLOGIC’S Galaxy platform in collaboration with  Μηχανογραφική – Οργανωτική Εκμεκτσόγλου & ΣΙΑ Ο.Ε.

This innovative software provides full tracking by creating a unique batch number which referring to a specific production and links all available data on the final product. This includes:

  • batch numbers and required data on API’s, excipients and packaging consumed in that production, such as CoA, MSDS etc.
  • contact information of the prescribing doctor and of the patient, the medication’s directions for use and a copy of the prescription.
  • signatures of the production manager, release officer and laboratory personnel and a digital signature of release documents.
  • all available references concerning the production (formularies, scientific data etc.)
  • all available recordings of the weighing of the API’s and the excipients, of the visual inspection of the final product and all the results of the quality control essays.

This software produces the following documents for each batch:

  • Order form.
  • Availability form (ingredients and packaging).
  • Production guidelines.
  • Production form
  • Release form
  • Label of the final product with the following information: batch number, name of the prescribing doctor and of the patient, ingredients, production and use by dates, instructions for use, storage conditions and other special instructions if required.

By fully tracking all production procedures we can optimize production, inform healthcare professionals and patients about the prescription history and recall defective products, packaging, or raw materials if necessary. This significantly enhanced monitoring increases safety.

Based on the guidelines of the Resolution CM/Res(2016)1 we have developed an algorithm which calculates the risk assessment for each compounded medicinal product, by determining the category of the preparation, using objective criteria, before proceeding with the manufacturing process. Formulations classified by the algorithm as high risk require GMP conditions, while the rest require GPP conditions.

State of the edge laboratory equipment

We believe that by achieving this degree of automation, by recording and controlling critical points through the four eyes principle at all stages, from ordering to production and release, we ensure the quality of the compounded medicine. These pivotal factors could be said to be just as essential as the quality of the equipment and the training of the staff.

Together with our partners, we are at the disposal of health professionals who wish to implement a similar level of computerization in their laboratory, by sharing our knowledge and experience.