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Technical quality agreement for contract manufacturing templateTechnical Quality Agreement • December 23rd, 2021
Define the documentation needed to support the results, including product or service information, certificate of analysis, material safety data sheets, production summary, deviations and OOS surveys, and declaration of conformity to quality assurance. Depending on the nature and status of the ratio and quality metric performance, additional documentation, such as batch records and raw test data.:Define how the owner will monitor the performance of the OCM. Include e.g. number/frequency of deviations, number/frequency of OOS results, internal audits and performance of regulatory audit, continuous process verification, customer complaints and adverse eventsDefine review times and frequency and continuously review performance to avoid loss of a component or service that would cause a loss of a component or service. Supply chain disruption and increased risks to patient safety. A well-structured quality agreement can be an important tool to enable effective cooperation between owner and CM
