Qualification and Validation
we understand the importance of validation and qualification in ensuring the quality, safety, and efficacy of pharmaceutical products.
Validation is the process of demonstrating that a process, system, or equipment consistently produces the desired results, meeting the regulatory requirements and industry standards. This includes the development of a validation plan, protocol, and report, as well as executing the validation study and documenting the results.
Qualification is the process of demonstrating that equipment, systems, or facilities are suitable for their intended use and meet the regulatory requirements and industry standards. This includes activities such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Our team of experts provides comprehensive validation and qualification services, including:
- Validation master planning
- Validation protocol and report writing
- Execution of validation studies
- Equipment and system qualification
- Data integrity assessments
We work closely with our clients to understand their needs and develop a tailored approach that meets their specific requirements. Our goal is to ensure that our clients’ processes, systems, and equipment are validated and qualified to the highest standards, supporting regulatory compliance and the quality of their products.
Equipment Qualification (EQ)/Utility Qualification
This includes activities such as System Design Qualification (SDQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Computer System Validation (CSV)
This includes the development of a validation plan, protocol, and report, as well as executing the validation study and documenting the results.
Process Validation
This involves the validation of production processes to demonstrate that they consistently produce the desired results, meeting the regulatory requirements and industry standards.
Cleaning Validation
This includes the development of a validation plan, protocol, and report, as well as executing the validation study and documenting the results.
Method Validation
This involves the validation of analytical methods used to test the quality and purity of pharmaceutical products. This includes the development of a validation plan, protocol, and report, as well as executing the validation study and documenting the results.
Water Qualification
This includes Qualification activity of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). And involves in development of a PQ protocol and report as well as executing the validation study.
We Provide the Best Service in Industry
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