Consultancy

As Sr Consultant, De Jong Pharma Consult has extensive experience in the pharmaceutical industry. We have successfully driven improvement programs in the Quality Assurance area. Some examples are:

Deviation System:

  • Design and Develop a new deviation system
  • Write the procedures and training material for the new system
  • Implement and train the new system and procedures

–> This program reduced the number of deviations by 90% due to having an effective deviation management system that actually improves the processes and prevents future deviations.

Training System:

  • Design and Develop a new Training system
  • Write the procedures and training material for the new system
  • Implement and train the new system and procedures

–> This program reduced the workload of the training coordinator by 70% due to having a workable training system that required much less administrative tasks. The training coordinator could now focus on actually training staff versus being overwhelmed with paperwork.

Documentation System

  • Design and Develop a new Documentation
  • Write the procedures and training material for the new system
  • Implement and train the new system and procedures

–> This program reduced the number of procedures and work-instructions by 50% by focusing the documents on the important subjects. Also, the size of the documents was significantly reduced, e.g. by using flow charts and RACI matrices.

Supplier Management System

  • Design and Develop a new Supplier Management system
  • Write the procedures and training material for the new system
  • Implement and train the new system and procedures

–> The new Supplier Management System allowed the company to prioritize the suppliers towards criticality and product impact in a scientific risk based and objective manner. As a result, some suppliers were no longer audited on-site but remotely, and vise versa. In the end, the total workload of the supplier management system was not reduced, however, the total control on the suppliers and the confidence in the system was improved dramatically.

Batch Record Review

Batch Release preparation of both clinical and regular manufacturing and packaging batches through:

  • Master Batch and Packaging records review and approval
  • Executed Batch and Packaging records review and approval
  • Deviation and Change Control review and approval
  • Review of analytical records, including physical, chemical and microbiological analytical records
  • Creation and approval, or review of Certificate of Compliance, GMP statement, Batch Release recommendation.