Comprehensive Validation Services
Our Validation Services encompass every aspect of your production and cleaning processes, ensuring regulatory compliance, product safety, and operational efficiency.
Process Validation
Our process validation service guarantees that each manufacturing process produces consistent, high-quality products that meet regulatory requirements. Centecura Healthcare employ a structured validation approach that includes:
- Process Design: Developing a robust process design based on product requirements and regulatory expectations.
- Process Qualification: Verifying the performance and consistency of the process across batches.
- Continued Process Verification: Implementing ongoing monitoring to ensure sustained process reliability and quality.
Our Process Validation Approach
- Validation Master Plan (VMP): A strategic plan detailing the entire validation process, scope, and methods.
- Process Consistency: Ensuring that each batch is consistently produced within predefined limits.
- Quality by Design (QbD): Applying QbD principles to understand and control variability in processes.
- Documentation: Comprehensive documentation of process validation results and deviations.
- Ongoing Monitoring: Continued process verification to ensure that processes remain in control.
Cleaning Validation
Our cleaning validation service ensures that your manufacturing equipment meets cleanliness standards and avoids cross-contamination risks. This service includes:
- Sampling and Testing: Comprehensive analysis to verify that cleaning processes effectively remove contaminants.
- Validation Protocols and Training: Custom protocols for various equipment, materials, and product types.
- Regular Monitoring: Continuous assessments to adapt to new regulatory requirements and changes in production demands.
Our Cleaning Validation Approach
- Establishing Acceptance Criteria: Setting limits for residual levels of active pharmaceutical ingredients (APIs), cleaning agents, and microbial contaminants.
- Validation Protocols and Training: Detailed cleaning validation protocols covering equipment and environmental cleaning methods.
- Matrixing: A streamlined cleaning validation approach that tests a selection of products and equipment to ensure effective results across all scenarios.
- Worse Case Identification: Identifies the toughest cleaning scenarios to ensure robust, compliant processes in all conditions.
- Analytical Methods: Developing and validating precise analytical methods to detect residues.
- Documentation and Record-Keeping: Thorough documentation of all cleaning procedures and validation results.
- Regular Revalidation: Periodic revalidation to ensure the cleaning process remains effective over time.
PDE Value Validation Service
Our PDE Value Validation Service ensures compliance with regulatory standards by determining safe exposure limits for residual substances in pharmaceutical products.
Core Elements:
1. Risk Assessment: Comprehensive evaluation of toxicological data.
2. Threshold Determination: Accurate calculation of PDE values.
3. Analytical Precision: Validation of methods to detect and quantify residual levels.
4. Regulatory Compliance: Aligning with global standards to minimize cross-contamination risks.
5. Documentation: Detailed records for audit readiness and long-term compliance.
Why It Matters?
1. Protects patient safety by mitigating exposure risks.
2. Ensures multi-product manufacturing safety.
3. Facilitates seamless regulatory approval processes.
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Why Choose Validation Services?
Improved Compliance:
Ensure all procedures align with regulatory requirements.
Cost Effective Process:
Streamline processes for faster approval times.
Error Reduction:
Reduce the risk of miscommunication and procedural errors.
