Qualification & Validation Services

We provide comprehensive Qualification & Validation services essential for ensuring that your pharmaceutical facilities and processes meet the highest standards of quality, compliance, and operational integrity. Our services encompass Temperature Mapping, Equipment Qualification, and ISO Cleanroom Validation, each critical to maintaining the efficacy and safety of pharmaceutical operations.

1. Temperature Mapping

Purpose and Scope

• Environmental Monitoring: Temperature Mapping involves monitoring and recording temperature variations within controlled environments to ensure that all areas meet specific temperature requirements.
• Regulatory Compliance: This process is vital for compliance with cGMP regulations and ensuring that storage conditions for sensitive products, such as pharmaceuticals, are consistently maintained.

Methodology

• Strategic Placement: We use strategically placed data loggers throughout the facility to capture temperature data at various points, ensuring comprehensive coverage of all critical areas.
• Data Analysis: Our team analyzes the collected data to identify any temperature deviations and assess the performance of temperature control systems.
• Reporting: We provide detailed reports highlighting temperature fluctuations, system performance, and any necessary corrective actions to maintain compliance.

Validation

• Verification: Temperature Mapping serves as a foundational step in validating that your facility’s temperature control systems are functioning as intended and maintaining required conditions.

2. Equipment Qualification

Purpose and Scope

• Ensuring Performance: Equipment Qualification is designed to verify that equipment operates correctly and consistently according to its intended use and meets regulatory requirements.
• Compliance Assurance: This process is critical for ensuring that equipment used in manufacturing and testing processes is reliable and compliant with cGMP standards.

Qualification Phases

• Design Qualification (DQ): We assess the equipment’s design to ensure it meets all specifications and requirements for its intended use.
• Installation Qualification (IQ): This phase involves verifying that the equipment has been installed correctly and according to manufacturer specifications.
• Operational Qualification (OQ): We test the equipment under operational conditions to ensure it performs as intended and meets performance criteria.
• Performance Qualification (PQ): The final phase involves verifying that the equipment consistently performs according to operational specifications under normal working conditions.

Documentation and Reporting

• Detailed Documentation: We provide thorough documentation for each qualification phase, including test protocols, results, and any necessary corrective actions.
• Compliance Reporting: Our reports ensure that all aspects of equipment qualification are recorded and meet regulatory and industry standards.

3. ISO Cleanroom Validation

Purpose and Scope

• Ensuring Cleanroom Integrity: ISO Cleanroom Validation is essential for verifying that cleanrooms meet the stringent cleanliness and environmental control standards required for pharmaceutical manufacturing.
• Regulatory Compliance: This validation ensures compliance with ISO standards (e.g., ISO 14644) and cGMP regulations, maintaining the required levels of cleanliness and environmental control.

Validation Process

• Cleanroom Classification: We assess cleanroom conditions against ISO classifications, including particle counts, airflow patterns, and pressure differentials.
• Environmental Monitoring: Our validation includes comprehensive monitoring of temperature, humidity, and particulate levels to ensure compliance with specified limits.
• Pressure Differential Testing: We measure and verify the pressure differentials between cleanroom areas to prevent contamination.

Reporting and Documentation

• Validation Reports: We provide detailed validation reports, including data on environmental conditions, testing results, and compliance status.
• Corrective Actions: Any deviations from required standards are documented, and we provide recommendations for corrective actions to ensure ongoing compliance.