Change Control and GMP Compliance

Change control systems deal with planned, foreseeable changes and are one of the most important components of a quality management system.It is not without reason that the EU GMP Guide Annex 15 (Qualification and Validation) with its "change control" requires a written procedure to record the implementation measures for intended changes to products and processes.  This is because the manufacturing process rarely remains as originally described for approval. Effective change management is required to maintain GMP compliance even after the changes have been made.

If changes in the manufacturing process of active ingredients or pharmaceutical and biotechnological products are requested, the relevance of the respective change is first classified and accompanied by a risk analysis. This often leads to different questions - e.g. which changes actually have to be notified to the authorities, who has to be informed about the changes, whether a re-qualification is necessary or whether the approval might even be doubted.

On December 11 and 12, 2020, the practical seminar "Change Control and GMP Compliance - Planning, Implementation and Monitoring of Changes" will take place as a full-day online training course of the FORUM Institute, which will provide strategic and operational know-how for effective and successful change management. In addition to legal framework conditions, participants will be provided with practical knowledge. Raimund Brett, Principal Consultant at gempex, will be involved in this event as a leading GMP expert in two sessions.

Reasons of changes based on case studies

  • Process deviations
  • Complaints (focus on quality)
  • New suppliers and machines
  • Product improvements (trend analyses)
  • Requirements of authorities and customers

GMP and Regulatory Compliance

  • Where are the GMP compliance pitfalls?
  • By which methods can "continuous" compliance be obtained?
  • Information and communication management in practice

Further topics are planning, implementation and monitoring of changes, legal framework and successful cooperation with regulatory affairs. The know-how imparted will be applied in two workshops during the event and will enable the participants to understand and apply the basics of the change control system after completion of the online training. Further information on the event can be found on the organizer's website (only German).

If you have any questions about change management and GMP compliance, Raimund Brett will be happy to answer them personally. Please contact him via: