Globiox auditors can conduct Good Manufacturing Practices (GMP) audits of drug manufacturers to ensure compliance with FDA, EMA, and other regulatory requirements. GMPs are a key part of drug manufacture and include requirements for maintaining a facility, equipment, quality systems, labeling, storage, and distribution, to name a few.
Globiox's team of expert GMP auditors ensure your company has conformed to ever changing regulations. Below is an abbreviated list of some GMP audits we perform. If you require a specialty audit, or an audit type not listed below, contract our team for a free evaluation of your GMP needs.
- Quality Control Lab Audit
- Supplier Audit
- Data Integrity Audit
- Facilities Audit
- Biologics
- Medical Devices
- Gene Therapy
- Parenterals
- IV Dosage Forms
- Tissue Engineering
- Design and Construction
- Mock FDA and EMEA
- Packaging
- Labeling
- Distribution
- Storage
- Etc
- Batch Record Review for Quality Control
- Process and Validation protocols, execution, distribution, and storage
- Quality Management Systems