Simplifying, Processing, Remediating
A small IMP manufacturing facility, with its origin in non-pharma, had developed over a short period of time to manufacture a wide range of IMP dosage forms. The majority of the small number of staff in the organisation had been with the company from its beginnings and were not of a GMP background. The company identified this risk to the future of the organisation and enlisted JWQC as part of its project team to help redress the GMP balance.
With JWQC support, the team were able to:-
- Conduct risk assessments of the organisations’ key processes, identifying areas of priority for improvement
- Raise GMP awareness throughout the organisation, performing training and mentoring of staff
- Improve, implement and train out key GMP processes
- Introduce sound project management to ensure full control for each IMP manufacture
- Reduce the risk to the organisation of significant regulatory inspection findings
The result of an intensive program was that the organisation maintained its GMP certificate and continued to operate with a strong team of personnel who were more competent in the interpretation of GMP.