Quality Operational Support
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At Syner-G, we understand that in the pharmaceutical industry, exceptional quality management extends beyond systems and documentation—it’s about hands-on, proactive support during critical operational processes. Our Quality Operational Support services are designed to seamlessly integrate with your operations, ensuring that every phase of your project is executed under the highest standards of quality and compliance.
Comprehensive Support Services
Person-in-Plant Support
Our Person-in-Plant (PIP) services place our expert QA personnel directly in your manufacturing facilities. By being on-site, our staff can provide immediate guidance and oversight, ensuring that manufacturing processes are compliant with all applicable quality standards and regulations. This direct involvement helps in minimizing risks and enhancing product quality.
Technology Transfer and Process Validation
Technology transfer and process validation are critical steps in pharmaceutical manufacturing that require meticulous planning and execution. Our Quality Operational Support includes comprehensive oversight during these phases to ensure processes are properly scaled up and validated. We help confirm that all aspects of your operation align with established protocols and regulatory requirements, thus supporting a smooth and compliant production cycle.
QA Oversight and Compliance Monitoring
Our dedicated team provides ongoing Quality Assurance (QA) oversight and compliance monitoring across your operations. From routine inspections to continuous process monitoring, we ensure that your operations adhere to the highest quality standards. This not only helps in maintaining regulatory compliance but also in instilling confidence among stakeholders and consumers.
Audits and Assessments
Internal
Audits
Syner-G’s internal audits are thorough and objective assessments designed to check the efficacy of your internal quality systems and controls. Our audits identify areas for improvement and help ensure your operations remain compliant with all current pharmaceutical regulations.
PAI-Readiness Assessments
Pre-Approval Inspection (PAI) readiness is crucial for ensuring that your facility and operations meet FDA standards and are ready for regulatory review. Our experts provide detailed assessments and support to prepare your team and processes for PAI, increasing the likelihood of a successful inspection.
GMP Investigations and Deviation Management
In case of any deviations from standard procedures, our team is skilled in conducting detailed Good Manufacturing Practice (GMP) investigations. We help identify the root causes of deviations and implement corrective actions to prevent recurrence, ensuring the integrity of your manufacturing process.
Benefits of Quality Operational Support
Enhanced Product Quality
With our hands-on support, your products are manufactured under the strictest quality controls, enhancing overall product safety and efficacy.
Regulatory Compliance
Our continuous oversight and proactive compliance monitoring ensure that all operations meet the latest regulatory standards, helping to avoid costly penalties and delays.
Operational Efficiency
Our support optimizes your operational processes, reduces waste, and increases productivity, directly contributing to your bottom line.
Risk Reduction
By identifying and mitigating risks early, we help protect your products and your business from potential quality issues and compliance pitfalls.
At Syner-G, we are committed to providing you with the Quality Operational Support needed to navigate the complex landscape of pharmaceutical manufacturing. Our expert team is ready to integrate with your operations and help you achieve excellence in every product you produce.