CASE STUDY: FOTMER GMP FACILITY
Client: Fotmer Corporation
Location: Montevideo, Uruguay
GMP stands for Good Manufacturing Practices and is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
WHO (World Health Organization) has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP.
GMP requires that people work in an orderly and methodical way and that work areas are neat, tidy and, there is segregation between tasks where required.
Fotmer Dry & Cure Facility at Nueva Helvecia, Colonia is intended to ensure all the post-harvest processes for the whole production of Fotmer’s cultivation facility also at Nueva Helvecia of medical Cannabis dry flowers.
The facility had to be compliant with the MoH standards and the most restrictive EU-GMP guidelines.
The timeframe was so ridiculously tight that everyone took for granted that the facility would not be ready on time, and against all odds, we managed to not only have the facility ready but also to implement sufficient time for commissioning plus going through all the GMP certifications and MoH mandatory audits before having the green light to start processing.
Everyone engaged early
The strategy we used was based on the "everyone engaged early" axiom. It’s an integrative interdisciplinary effort that allows all stakeholders to share information and work together toward common goals and objectives—not in separate silos.
We lead the process acting at the same time as the client’s rep and as an advisor on hazard and operability concerns, "what-if" situations, Lean Six Sigma issues, and GMP reviews. This way we helped to avoid costly process flow diagram redesign and keep both cost and schedule on track