Q07 Manufacturing Operations in Quality Management System

The Manufacturing Operations is the core of most businesses’ quality system. Our GMP document templates cover all aspects of the Manufacturing Operations:

Manufacturing Operations in Quality Management System

Q07-0000 Manufacturing Operations in Quality Management System


  • Q07-00  Policy Statement
  • Q07-10  Product Realization –
    • this is the planning of product objectives, resource requirements.
    • Develop a Quality Plan.
  • Q07-20  Customer Requirements –
    • determine Statutory and regulatory requirements applicable to the product
  • Q07-30  Product Design, Validation –
    • Plan and control the product design and development.
    • Appropriate review, verification, and validation activities for each stage
  • Q07-40  Purchasing of Goods –
    • Evaluate and select suppliers based on their ability to supply product in accordance with the requirements.
    • Establish the criteria for selection, evaluation, and re-evaluation.
    • Maintain the results of the evaluations and subsequent follow-up actions.
  • Q07-50  Perform & Monitor (QC) Manufacturing – Plan and carry out production and service provision under controlled conditions to include, as applicable:
    • develop product characteristics information
    • Availability of work instructions
    • Ensure suitable equipment and resource
    • Validation – Equipment Qualification, Process Validation, Cleaning Validation
    • Implementation of product release, delivery, and post-delivery activities
  • Q07-70  Measuring Devices –
    • control of monitoring & measuring devices
    • Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity.
    • Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
    • Calibration program & schedules for devices
  • Q07-80  Address Non-conformance:
    • Ensure any nonconformities are identified and controlled
    • Deviation investigation and reporting, CAPA

NOTE – there will be more GMP Templates coming in the near future.  Please contact us if you have specific needs.