Operating Procedures content development

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

HCF procedure development maintains consistency by follow/ing the TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) and the SNL ES H Manual (SNL 1998b). These documents describe procedure format and content, including Purpose, Scope, Ownership, Responsibilities, Definitions and Acronyms, Hazard Identification, Equipment and Materials, Format, Review and Approval Authority, and Document Control. Use of this format complies with DOE Order 5480.19, Conduct of Operations, Chapter 16 (DOE 1990). TA-V Standard Operating Procedures are written for tasks specifically identified in the Technical Safely Requirements (TSR) or as required by other directives or the SNL ES H manual to address special hazards. TA-V document types and hierarchy is described in TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) Chapter 16. 

The Data Architecture activity moves in a similar direct manner, starting with the design and identification of the necessary data and content categories that will support the CRM effort. It proceeds to creating the data sources to be accessed, identifying those responsible for ownership of the data, and instituting a test to determine that the correct information can be effectively accessed. The proper reports and analytical procedures are developed and the data model is finalized and tested under operating conditions. 

A novel procedure was developed to improve psyllium functionality by conducting a solid-state enzyme reaction. The procedure requires no special equipment/operation (such as freeze dry) and could be carried out without using any additional chemicals. To evaluate the solid-state enzymatic procedure, modified psyllium preparations were produced under selected reaction conditions, and analyzed for their water-absorbing capacity, gelling capacity, particle surface structure, and soluble and insoluble fiber contents. The results showed that structural modification improved psyllium functionality. Modified psyllium preparations had reduced water-absorbing capacity and less gelling ability. The reduced water-absorbing capacity may be explained by the decreased surface area of psyllium particles. In addition, the solid-state enzymatic treatments had much less effects on soluble fiber contents than the liquid phase enzymatic reactions. 

The information on the container and the development pharmaceutics is to cover the qualitative composition (polymeric and other), closure type and method of operation, tightness of the closure, dosing device information, tamper evidence and child resistance, stability of the product in the container, the method of administration of the medicinal product, any sterilization procedures, the ability of the container to protect the contents from external factors,... 

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