Qualification and
Validation
The ATP-CGPharm Group offers a broad range of qualification and validation services according to the newest international standards.
The company supports its clients in planning, coordination, supervising and execution of qualification and validation activities and in preparing the required documents.
What’s inside
30+ years of Experience in Qualification and Validation
At ATP-CGPharm Group, our highly experienced engineers, pharmacists, and technicians specialize in creating key GxP-compliant documents essential for qualification and validation. With over 30 years of expertise, we develop comprehensive Qualification and Validation procedures, Master Plans, Risk Analyses, and Traceability Matrices to ensure your operations meet the highest regulatory standards. Additionally, we prepare detailed reports and action plans, including Deviation Reports and Qualification Master Reports, ensuring transparency and compliance.
DQ - FAT - SAT - IQ - OQ - PQ
Qualification & Validation
Ensuring Compliance at every single stage
Our Facility & Process Engineering Services
Qualification & Validation
We design and coordinate the professional and GxP-compliant implementation of various areas. We offer a range of services designed to support your facility’s design, optimization, and compliance needs. From initial planning to final execution, we ensure that each project meets the highest standards of performance and safety.
Documentation Services
Our experts are specialize in preparing a wide range of GxP-compliant documents. These include procedures, master plans, user requirement specifications, risk analyses, traceability matrices, validation plans and reports, deviation reports, action plans, and master reports. We also provide requalification and revalidation procedures, ensuring full compliance with industry standards.
Qualification Services
Our expertise covers cleanrooms, HVAC systems, process and laboratory equipment, and temperature and humidity-controlled areas, including storage areas, warehouses, stability chambers, incubators, refrigerators, and freezers. Additionally, we specialize in qualifying essential utilities such as purified water, water for injection, pure steam, compressed air, and process gases.
Validation Services
ATP-CGPharm Group excels in a wide range of validation activities to ensure compliance and operational efficiency. Our services include cleaning validation, process validation, computer system validation, analytical method validation, and the validation of disinfecting agents, all designed to meet the highest regulatory standards.
QA Systems
Your Path to a Robust Quality Assurance Framework - We support our clients in designing, implementing, and optimizing complete, GxP-compliant Quality Assurance systems. From documentation and SOPs to risk management and audit readiness – we deliver tailored solutions that ensure regulatory compliance and operational excellence.
- After completion of Qualification and Validation we can also define and perform the Routine Monitoring activities.
- If you perform your Qualification and Validation activities with internal resources, we can also support your team by Furnishing of Qualified Staff (Staff Leasing).
After completion of Qualification and Validation we can also define and perform the Routine Monitoring activities.
If you perform your Qualification and Validation activities with internal resources, we can also support your team by Furnishing of Qualified Staff (Staff Leasing).
Why Choose US?
Key Benefits of ATP-CGPharm Group for Your Qualification & Validation
ATP-CGPharm Group offers tailored qualification and validation solutions designed to help you meet the highest standards of compliance and operational efficiency.
Regulatory
Expertise
We ensure full compliance with industry standards, reducing risks and delays.
Tailored
Solutions
Customized services to optimize performance and meet your unique needs.
Risk
Reduction & Efficiency
Identify risks early and improve operational efficiency, saving time and costs.
Real-World Results
Challenge: The client struggled with manual processes that were time-consuming and prone to errors, affecting product consistency and speed.
Solution: Our team implemented automated solutions for key production processes, including real-time monitoring and data logging systems. We customized the automation to meet the client’s specific needs and ensured that all systems were GMP-compliant.
Outcome: The client saw a 25% increase in production capacity, reduced human error, and improved product quality.
Challenge: The client struggled with manual processes that were time-consuming and prone to errors, affecting product consistency and speed.
Solution: Our team implemented automated solutions for key production processes, including real-time monitoring and data logging systems. We customized the automation to meet the client’s specific needs and ensured that all systems were GMP-compliant.
Outcome: The client saw a 25% increase in production capacity, reduced human error, and improved product quality.
