Even routine inspections can be stressful. These system based inspections mean that inspectors examine the processes and procedures currently in place and used by a Marketing Authorisation Holder to comply with existing EU and national pharmacovigilance regulations and guidance.
What is covered during a routine inspection?
Some of the areas the inspectors will focus on are:
- Spontaneous case processing
- PSUR production
- Signal generation
- Contracts and agreements
- Clinical trial pharmacovigilance
- How documents are being stored and managed
- All training is fully documented and staff appropriately qualified
- Updates to labels
How can Essjay Solutions help?
We can help take the stress away from impending inspections by training all staff up for the inspection process and educate them on what is to be expected. Essjay Solutions can initiate rehearsal inspections and prepare remedial action plans prior to inspection reports being issued. Essjay Solutions are highly experienced in supporting pharmaceutical companies with their pharmacovigilance needs and have helped numerous clients globally ensure all their systems and process are up to scratch before the inspectors arrive.