GMP consulting and training services

ITVC Global supports businesses in establishing and implementing GMP in their operations. The service includes the following activities:

1. Documentation and management system consulting

• Guide the establishment of system management policies
• Plan and compile the GMP documentation structure
• Guide the development of the documentation system
• Manage, plan and track revisions to documents and records
• Advise on annual product reviews and product stability monitoring

2. Training

WHO GMP training covering documentation and records, validation, qualification, incident and deviation management, inspections, recalls, complaints, product release and GMP registration.

3. Incident, deviation and self-inspection management

3.1. Incident and deviation management

Advise on responses to incidents during manufacturing and testing, and on measures to prevent recurrence.

3.2. Self-inspection

• Plan and conduct annual self-inspections
• Track, encourage and consolidate actions responding to inspectors’ recommendations
• Plan for external inspections
• Monitor GMP compliance across departments
• Update and revise documentation related to self-inspection
• Manage inspection and self-inspection records

4. Release of materials and products

4.1. Material release

• Prepare annual plans for managing material release
• Review materials for release
• Monitor GMP compliance in material management

4.2. Release of intermediate and finished products

• Review manufacturing and testing records for each batch to support release of intermediate and finished products
• Prepare finished-product release records and documentation for national control authority lot release where required for the product category
• Manage product release records

5. Qualification and validation

• Develop the validation master plan and validation policy
• Plan annual qualification and periodic validation activities
• Manage qualification and validation records