Audit Services
JWQC takes a pragmatic, risk-based approach to auditing. Our services will fulfil your audit requirements whether you are a sponsor, pharmaceutical manufacturer or contract test laboratory.
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.
For more information on our audit offering see here.
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.
Audits conducted 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.
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
ATMP Manufacturers
Drug product Manufacturers
Fill and Finish Sites
Secondary Packaging
Clinical Trial Labelling
Contract Test Facilities
Audits to Facilitate Improvement of the Pharmaceutical Quality System
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
Examples of our work
Now, let’s talk:
Call: +44 (0) 7803 603041
Email: enquiries@jwqc.co.uk
Alternatively, ask a question on our contact page