Establish foundations for compliant GMP operations 

• Perform operational and GMP readiness gap assessments and remediation planning 

• Evaluate facility, utilities and equipment qualification status and prepare the project plan 

• Check and update as necessary master production records, manufacturing instructions and process-related SOPs

• Support material sourcing, vendor selection and qualification 

• Bring material management and GMP warehouse operations into compliance 

• Assess personnel training and qualification, update or design from a scratch on-the-job training curricular

• Provide GMP readiness project management through the campaign go/no-go decision or 

Outcome: A coordinated, execution-ready GMP operation capable of compliant clinical or commercial product supply