Qualification and validation are critical steps in industrial engineering, especially in the food and pharmaceutical industries. These processes provide assurance that equipment, systems and processes meet established standards of quality, safety and efficiency.
The essence of the service:
- Qualification is the systematic process of verifying and confirming that equipment and systems are operating in accordance with design specifications. This includes checking the installation, operating parameters and performance.
- Validation is the process of proving that a system or process is capable of achieving intended results throughout its life cycle.
Advantages:
- Ensuring compliance with international standards and regulatory requirements, which is important for obtaining licenses and permits.
- Reducing the risks of errors and defects in production, which can lead to serious consequences.
- Optimization of production processes, which leads to increased productivity and reduced costs.
- Guarantee of product reliability and quality, which increases consumer confidence.
Our company provides a comprehensive approach to qualification and validation, allowing you to focus on the core tasks of your business, knowing that your systems and processes are working reliably and efficiently.
We offer qualification and validation of various processes, systems and equipment, including:
1. Equipment:
- Qualification of production equipment such as reactors, fermenters, filling machines, packaging lines and others.
- Qualification of auxiliary equipment: pumps, compressors, heat exchangers, etc.
- Qualification of analytical equipment (for example, spectrometers, chromatographs) in quality control laboratories.
2. Processes:
- Validation of production processes to ensure the stability and quality of the final product.
- Validation of sterilization processes (autoclaving, SIP/CIP systems) in the pharmaceutical, biotechnological or food industries.
- Validation of equipment cleaning and disinfection processes.
- Validation of packaging processes to ensure product protection and compliance with standards.
3. System:
- HVAC (heating, ventilation and air conditioning) systems qualification for clean rooms.
- Qualification of water treatment systems (production of pure, purified water for injections).
- Validation of automation and control systems (SCADA, DCS, PLC) for the accuracy and reliability of management of production processes.
- Qualification of computerized systems in accordance with regulatory requirements such as GAMP 5 (Good Automated Manufacturing Practice).
4. Clean rooms:
- Qualification and validation of clean rooms for pharmaceutical, biotechnological, food industry or electronics production.
- Inspection of air quality, control of dust particles, temperature and humidity in clean rooms.
5. Validation of analysis methods:
- Laboratory procedure development companies can offer validation of analytical methods to ensure accuracy, specificity, reliability and reproducibility of measurements.
"MIRAS ENGINEERING" LLC provides qualification and validation services both within the framework of the implementation of new processes and systems, and during periodic inspections to maintain compliance with regulatory requirements (GMP, FDA, ISO, etc.).
