The compliance requirements of EU-GMP are numerous, and many projects don’t meet their deadline.
RS NESS supported a company in reaching this goal, and becoming the company to receive EU-GMP certification; we supported the Facility Validation, Production Validation, Shipping & Cleaning validation, and updating all the procedures and drawings, as required for EU-GMP compliance.
This case study describes our 5 steps process to meet this challenging goal.
A Medical Cannabis company has only 2 months to be prepared for a scheduled EU-GMP audit. The Manufacturing process is not yet finalized.
Step 1: Assemble your team.
- Assess the available resources. Few highly-professional team members can save time of repeated review cycles.
Step 2: Gap Assessment
Once you have a qualified team, it’s important to understand the gaps so you can move forward effectively.
We reviewed the procedures, equipment, facility conditions, and critical processes (such as production, cleaning, storage, and shipping, etc.)
- If new processes were planned, collaboration with the Development team is key.
- If new regulations are implemented, it’s important to keep the Regulatory team involved.
Step 3: Timeline
A detailed Gantt chart was prepared, including all tasks.
- Procedures may have a long lead time due to review cycles, take that into account when scheduling.
- Have the goal in mind, and a clear deadline.
Step 4: Preparing for Validation
Writing a Validation Master Plan (MVP), procedures, and forms required by GMP standards, and validation protocols.
We mapped the processes and identified gaps that prevented moving forward to validation; these were scheduled and addressed.
- Some gaps that may block your validation process are Validation Policy, and Equipment Qualification.
Step 5: Process Validation
Each time another equipment was ready for Qualification (considering Development, Engineering, and Quality)- the validation protocols were performed per plan.
- If some processes are not yet fully defined, or some equipment still missing, it’s critical to manage the project on a daily (and even hourly) basis.
- Agile project management is key to meet the tight schedule.
- Collaboration and open communication make this possible.
The hands-on project management, experienced personnel, and engagement of all stakeholders made it possible to meet the schedule.
The Medical Cannabis company passed the audit successfully, becoming EU-GMP certified.
RS NESS supports Life Science companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need, when you need it.
If you are planning your production validation, contact us to discuss how we can support your goals