21 CFR Part 210
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
Capabilities — CQV
CQV Services — Commissioning, Qualification & Validation
Risk-based qualification and compliance assurance based on ISPE guidelines and 21 CFR Part 11. Guiding cleanrooms, equipment, and automated utilities through DQ, IQ, OQ, and PQ for seamless inspection readiness.
CQV Services
Commissioning, Qualification & Validation
Clean and Control delivers structured, risk-based validation frameworks aligned with ISPE, US FDA, and WHO cGMP guidelines. We ensure that every cleanroom envelope, HVAC air cascade, water generation loop, and automated process system is systematically qualified (DQ, IQ, OQ, PQ) and backed by rock-solid data integrity protocols for regulatory approval.
Regulatory & industry guideline references
To learn more, explore these CQV industry guideline references that form the basis of our commissioning, qualification and validation approach.
21 CFR Part 211
Current Good Manufacturing Practice for Finished Pharmaceuticals
Baseline Guide 5
Commissioning and Qualification (Second Edition)
GAMP 5
A Risk-Based Approach to Compliant GxP Computerized Systems
Process Validation
General Principles and Practices
Q6A and Q6B
Specifications: Test Procedures and Acceptance Criteria
Q7
Good Manufacturing Practice for Active Pharmaceutical Ingredients
Q9
Quality Risk Management
Q10
Pharmaceutical Quality System
Q11
Development and Manufacture of Drug Substances
Q12
Lifecycle Management
E 2500
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment