supporting global quality in the manufacture and distribution of medicine
Regulatory Inspection Preparation
- Covers GMP and GDP inspections
- Support companies in obtaining EU GMP certification
- Specialise in preparation for MHRA (Medicines and Health Regulatory Authority) inspections
- We create and follow through checklists for inspection readiness
- Provide general staff training on MHRA inspection requirements
- Creating a list of stationery and electronic systems required for the inspection
- Setting up electronic systems to support ’back room’ and ’front room’ communications
- Conduct audit rehearsals – for lead and support functions
- Conduct Pharmaceutical GMP and GDP Gap analysis audits
- Conduct Risk assessments
- Perform Quality Control checks on documents to be reviewed at the Regulatory Authority inspection
- Prepare and review Standard Operating Procedures
- Organisation of the ’back room’ for MHRA inspections – preparation for efficient retrieval of documents
- Organisation of ‘front room’ Q&A sessions
- Perform mock inspections