SOP on Design Qualification

1.0 Objective: To develop a document which provides a clear understanding of how the    equipment must perform.

2.0 Scope: A full description of the equipment specifying its acceptable operating ranges and limits.

3.0 Responsibilities: Quality Assurance Manager and Production Director are responsible for designing and laying down the specifications for an equipment.

4.0 Procedure: The basic design package should include the following – 

4.1  Flow schemes

4.2  A complete description of the features and function of the equipment.

4.3  Detailed specifications of the equipment.

4.4  Procedures for the cleaning system.

4.5  Preliminary SOPs for operating the system.

4.6  Preliminary system certification / calibration procedures.

4.7 Preliminary preventive maintenance procedures.