STANDARD OPERATING PROCEDURES

To enhance the assurance of the successful manufacturing operations, all process steps must be carefully written. The written process steps are often called standard operating procedures (SOP). No extemporaneous changes are permitted in the SOP. Any change in SOP must go through the same approval steps as the original written SOP. According to the FDA guidelines on the good manufacturing practices, extensive records must be kept to assure, at the end of the production process in that all steps have been performed as prescribed.

Such in-process control is essential to assure the quality of the product. Since this assurance is even more significant than those from product release testing. Production of quality product is a result of continuous, dedicated efforts of the quality assurance, production and quality control personnel within the plan in developing, performing and confirming effective SOP.

The process equipments and the components of the containers, cleaned thoroughly according to the required specifications are assembled in a clean environment. The assembled components are preferably sterilized and depyrogenated prior to use. All equipments and the supplies, introduced into the aseptic filling areas should be sterilized.

The outer surfaces of the boxes, packages, or equipments should be wiped with a disinfectant solution as they are transferred to clean room. All the supplies must be introduced into the aseptic filling room in such a manner that the aseptic state of these room is maintained, thereby, preventing the introduction of environmental contamination into the product while it is being subdivided into individual containers. After sealing of containers, contamination cannot enter into the container and the product. Thus the product is sealed in its final container within the aseptic room from where it is transported to packaging area. This area is maintained clean but need not meet the standard imposed for the aseptic room or for the sterile compounding room. Packaged products are placed in quarantine storage until all tests have been completed and in-process control records have been evaluated.