We work with you to understand the areas of focus that are important for your project. We then ensure that all audit time allocated by the auditee is used appropriately to work effectively for your needs.
Ensuring Good Manufacturing Practice
We confirm that the auditee has interpreted our findings correctly and that the findings will not adversely impact on GMP manufacture of your product or material. We check that responses to findings are appropriate for your requirements. A fully managed audit service by GMP experts frees your resource.
Audit reports, written by our Qualified Persons, are available for use by QPs at manufacturing sites when required as part of the QP declaration for imported Investigational Medicinal Products. Auditing is also frequently conducted as part of our contract QP service.
Active Substance, Drug Product, Clinical Trial Material
Our comprehensive audit services, used by our clients in the UK, EU, USA and elsewhere, can be tailored to meet your requirements, and include:
Audits of GMP Manufacturing and Test Sites
- API Manufacturers
- Drug product Manufacturers
- Fill and Finish Sites
- Secondary Packaging
- Clinical Trial Labelling
- Contract Test Facilities
- Gap Analyses
- Self-Inspections and Internal Audits
- Process Mapping
- Mock Regulatory Inspection
- Mock Pre-Approval Inspections
Audits to Support Supplier and Service Provider Approval
- Raw Materials Suppliers
- Container Closure Component Suppliers
- Contract Test Laboratories (analytical and microbiological)
- Contract Storage Facilities