Cases |

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

Any manufacturer of medicines intended for the EU market must meet the GMP standards in their production processes. When building up a new drug substances manufacturing site, our client needed consultation on the GMP requirements, and to complement their own resources, a team of GMP and pharmaceutical chemical experts from DRA was set up. Despite the tight time frame and the complexity of the task, the project was successfully completed, allowing the manufacturer to submit their GMP license application in time. Result? Our client passed the GMP inspection with flying colours and managed to start the commercial production as planned.

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.

As our client started getting prepared for the authority inspection, they soon realised that they lacked both expertise and resources required for the task – both assets that DRA Consulting as a pharmaceutical consultancy company can offer. And so, DRA was called for help.

Flexible hybrid teamwork and seamless communication 

To tackle the challenge, DRA appointed several GMP and pharmaceutical chemical experts to a dedicated client team and offered their project managers and senior experts to work on client’s premises. One of DRA’s project managers acted as a team leader to ease the communication within the team and with the client. 

As there was no time to lose due to the rapidly approaching deadline, multiple subprojects had to be run in parallel. DRA made quick moves both by re-organizing resources and hiring new employees. The team proved to be agile and worked both on-site and remotely to ensure the most efficient utilisation of resources. 

GMP compliance status confirmed 

Thanks to a successful project lead by DRA’s experts, our client managed to reach all their key goals: 

  • 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.

Do you need consultation on GMP matters? 

Contact our Regulatory Services team