Cases |

New drug substances manufacturing site GMP certified thanks to DRA’s expertise

A client started getting prepared for the authority inspection. Soon they realised that they lacked both expertise and resources in building up a new GMP qualified manufacturing site for drug substances.

Comprehensive guidance on getting prepared for authority inspection 

To get GMP certified and to start production for the EU market, a medicines manufacturer must be able to show that they meet all their legal obligations and comply with the GMP requirements. Preparing for the GMP inspection carried out by a competent authority involves e.g.

  • writing and compiling documentation:
    • Standard Operation Procedures (SOPs)
    • validation reports for Quality Assurance (QA), Quality Control (QC) and manufacturing functions
  • ensuring that the established quality system meets the GMP requirements
  • working under tight deadlines due to the short time frame for submitting the GMP license application.

Solution Offered by DRA

  • GMP and pharmaceutical chemical experts were appointed to the team. The time frame was tight and multiple projects were run in parallel. The challenge was overcome by re-organizing resources and by hiring new employees effectively. One of the DRA’s project managers acted as a team leader within the team to ease communication and client’s resources.
  • The team worked both on-site and remotely to ensure the most efficient utilization of resources.

Benefits Delivered

  • The necessary quality documents were ready for the authorities in time.
  • The client submitted the GMP license application within the given time frame.
  • The client passed the GMP inspection.
  • The authorities granted them the GMP license.
  • Commercial production was started at the new manufacturing site as planned.

To tackle the challenge, DRA built a hybrid team of GMP and pharmaceutical chemical experts enabling seamless communication and the most efficient utilisation of resources.

Do you need consultation on GMP matters? 

Contact our Regulatory Services team