Our consultants are expert in Facility, Utilities, System and equipment, qualification. We use a Risk-Based Approach to Qualification that aligns with the EU, Health Canada, TGA, PMDA and USFDA thinking on qualification. This approach allows for greater flexibility in optimizing system performance before implementing the systems on the line. The Risk-Based Approach focuses qualification on the functions that have the greatest impact on and create the greatest risk to production.
Commissioning, qualification and validation are known as CQV. Commissioning ensures that facilities, systems and equipment are designed and installed as specified and function as intended. Qualification ensures equipment and systems function to produce products as per specified requirements.
The standard process includes the following steps:
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Design Qualification
- Risk Analysis / Failure Modes Effects Analysis (FMEA)
- Factory Acceptance Testing (FAT)
- Commissioning / Site Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Equipment and System Qualifications
- HVAC systems and Building Management Systems (BMS)
- Utility systems
- Temperature-controlled equipment
- Laboratory equipment
- Solid dosage products manufacturing equipment
- Semi-Solid products manufacturing equipment
- Packaging equipment
- Cleanrooms, Biologics & Vaccins
Cleanroom Qualification & Compliance
Cleanrooms are validated and then certified to a chosen class of ISO 14644-1. Each class of ISO14644-1 has its unique requirements that must be made for a facility to be classified in the specified classification. Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.
