Third-Party Services (CMO)

Performing audits of CMOs to evaluate their quality systems and compliance with contractual agreements. Refer auditing services for more information.

Conducting root cause analysis for quality issues encountered with CMOs and implementing CAPAs.

Managing CAPA processes to address and prevent issues related to third-party manufacturing.

Assisting with SOP preparation and implementation through training to ensure consistent quality and compliance in third-party operations.

Conducting gap analysis of quality systems against client standards, contractual agreements, and ISO standards such as ISO 9001 and ISO 22000.

Evaluating and managing risks associated with third-party manufacturers to maintain quality and compliance.

Establishing and managing quality agreements between clients and CMOs to ensure alignment on quality standards.

Handling deviations in manufacturing processes and ensuring effective RCA and corrective actions are implemented.

Managing changes in processes or systems to ensure they are controlled and compliant with quality standards.

Addressing and resolving complaints related to third-party manufacturing quality issues.

Investigating and managing quality-related incidents to minimize disruption and ensure compliance.

Assisting your organization or third-party contractors/CMOs in achieving certification for quality (ISO 9001) and food safety management systems (ISO 22000 integrated with HACCP). For more details, see our relevant pages.

Preparing your CMOs for regulatory, client, and internal audits to ensure compliance and smooth audit processes. See our auditing service for more information.

Providing training to CMO staff members to enhance their quality practices.