It is a requirement of EU GMP to manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate and do not place patients at risk due to inadequate safety, quality or efficacy.
Eudralex Volume 4 Chapter 1
Everyone involved in manufacturing throughout the complex supply chain is responsible for quality. GMP applies to all the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation.
TMQA can help you to understand and comply with these requirements, whether you are a manufacturer, sponsor, investigator, contractor or involved in any aspect of manufacturing.
Our experienced GMP experts will provide you with the audits, advice and training necessary to ensure this requirement is met in products you are manufacturing or others are manufacturing on your behalf.
TMQA’s Manufacturing (GMP) QA Services
- Vendor Selection Audits – CRO/CMO/Laboratories/Depots
- Supplier Qualification and Requalification Audits
- Manufacturing Facility Audits
- Labelling and Packaging Facility Audits
Pharmaceutical Quality System Services
- Assistance with Preparation and Hosting Regulatory Inspections
- Mock Regulatory Inspections
- Development of Quality Systems (QS) and Gap Analysis
- Supplier and Technical Agreement Generation and Review
Review of Manufacturing Activities
- Batch Manufacturing Record and Manufacturing Instruction Audits
- Marketing Authorisation Application / Common Technical Document Audits
- IVRS/IVRX Supply Audits
Our experience covers API to Finished Product Manufacture including IMPs and QC Testing Laboratories.