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Audit Services
Audit Services
Ensuring Compliance & Risk Mitigation for Pharma, Biotech, & Medical Device Manufacturers
At Isha’s GMP, our audit services and inspection processes use best-practice methodologies, advanced risk assessment tools, and in-depth regulatory expertise to help organizations achieve global compliance and operational excellence.
Why Choose Isha’s GMP for Audits?
- Expert Auditors with Global GMP Knowledge
- Comprehensive Risk Identification & Mitigation
- Regulatory Compliance with ICH, FDA, EMA & More
- Independent & High-Quality Third-Party Audits
Our Audit Services Include:
Site Audits & Qualification
- Audits of API/Formulation manufacturers in compliance with ICH Q7
- Evaluation of excipient manufacturers, contract manufacturers, and suppliers
- Packaging, labeling, and warehouse contractor audits
- Contract laboratory audits
Regulatory & Pre-Approval Audits
- Site audits of finished products
- Pre-inspection approval assessments
- Pre-regulatory assessment audits & gap analysis
- ContMock regulatory audits to prepare for FDA, EMA, MHRA inspections
Specialized & Investigative Audits
- CMO fact-finding inspections & investigative audits
- Auditing facilities for due diligence & compliance
- API/Formulation QP audits & certifications
Comprehensive Reporting & Risk Assessment
- Audit reports delivered within 15 days
- Detailed observations with corrective & preventive actions (CAPA)
- Techno-commercial audits for investment analysis
Key Benefits of Our Audit Services:
- Save time & money by outsourcing complex audit processes
- Reduce regulatory risks with internationally recognized API audit reports
- Independent, high-quality verifications ensure regulatory acceptance
- Lower audit burden for both manufacturers & suppliers
- Gain strategic insights with detailed risk assessments
Need Expert Audit Support? Contact Isha’s GMP Today!