Risk management: must-have for any pharmaceutical company

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. An efficiently implemented quality risk management system (QRM) ensures the quality of products throughout the entire life cycles and is an enabler of the Pharmaceutical Quality System (PQS).

The principles for setting up and implementing a QRM are described in ICH Q9 and Q10, as well as in the EU GMP Guidelines (Annex 15 & 20). DIN EN ISO 14971 serves as the quality risk management basis if medical devices are produced.

QRM is a process that is integrated into the quality management system (QMS) and consists of five phases:

  • Initiation of the process (procedure and scope of the QRM are defined)
  • Risk assessment (which errors can occur, what is the probability of occurrence and what are the consequences)
  • Risk control (measures to minimize risk)
  • Risk monitoring (implementing results from previous steps into QMS as well as the consideration of deviations and complaints)
  • Risk communication (sharing of the information obtained between all parties involved as well as customers and authorities)

The performance of risk analyses as a prerequisite for a qualified manufacturing process is not only sensible but is also required worldwide by regulations. If the knowledge gained from a risk analysis is regularly reviewed by an interdisciplinary team to ensure that it is up-to-date and the results are communicated to all departments involved, the leap from individual risk assessment to QRM has been made.

Throughout the process there are the principles that, on the one hand, the assessment of quality risks is based on scientific knowledge and, on the other hand, the effort of risk regulation is always appropriate to the risk level.

Valicare GmbH has extensive experience in advising pharmaceutical manufacturers in the expansion, development and implementation of a QRM system, as well as in the risk assessment of manufacturing processes and the necessary equipment.



Dr. Ellen Sons-Brinkmann

Business Development & Marketing


Phone: +49 69 153 293 709

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