- Internal cGMP Audits
- GLP Audits
- GCP Audits
- Contract Manufacturer Audits
- Quality Systems Evaluation
- Compliance Gap Assessments
- Mock FDA Audits
- Compounding Pharmacy Audits
- Pre Approval Inspection Support
- API ICH Q7A Audits
- Labeling/Packaging Audits
- Supplier Audits
- Surveillance Audits
- Validation Audits
- Design of Audit Programs
- Dietary Supplement Compliance Audits
-
Contact GQA
- 1-303-459-2382
- 1-866-216-2815
- info@gqaconsulting.com
-
Industry Definitions
ICH Q9: Quality Risk Management
The ICH Q9 guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.
»More terms