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:
Q07 MANUFACTURING OPERATIONS:
- 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.