Production capacity:
1. Enterprises should develop the product production process flow charts, and equipped with production equipment capable of completing the process.
2. The enterprise shall formulate production process control and management documents.
3. Enterprises should establish a production equipment management system, including repair, maintenance, and use, and production equipment to develop operating procedures, equipment in the obvious place to indicate the status of the equipment.
Inspection capacity:
1. Enterprises should have and production of products appropriate inspection equipment, and its accuracy should meet the inspection requirements.
2. Enterprises should be in accordance with the requirements of the inspection and development of raw material acceptance procedures, factory inspection procedures; inspectors should be trained to be able to independently and correctly complete the operation.
3. Enterprises should test equipment (including measuring instruments) management system.
4. Inspection equipment should be calibrated according to the prescribed cycle and have a clear sign of conformity.
5. Product production on the environment has special requirements, equipped with the appropriate environmental testing equipment.
-- The above information is provided by Gaiser Junbao - Medical. Pharmaceutical Information Consulting Organization