- 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
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Contact GQA
- 1-303-459-2382
- 1-866-216-2815
- info@gqaconsulting.com
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Industry Definitions
Quality Assurance
A planned and systematic set of activities to ensure that requirements are clearly established and the defined process complies to these requirements. This includes activities to ensure that variances in processes are clearly identified, assessed and improved. For drug products, these activities and actions are necessary to assure that the product meets all requirements as to strength,purity, and efficacy.
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