Procedures (SOP)

This SOP package features an SOP template that provides instructions for the preparation and execution of riboflavin coverage tests in washers and tanks.

This SOP package features an SOP template that provides a step-by-step procedure and test logs for thermal mapping a pharmaceutical refrigerator.

This SOP package features an SOP template that outlines the procedure for releasing incoming raw materials. A Material Receipt & Lot Testing template form is also provided.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of micro and ultra-micro analytical balances.

This SOP package features an SOP template that provides instructions for pre-use cleaning and disinfection, operation, and post cleaning for a Class II, Type B2 biological safety cabinet.

This SOP package features a standard procedure that defines a fully compliant GMP documentation system for any GMP facility.

This SOP package features a standard procedure outlining a completely defined and cGMP compliant training system.

This SOP package features a standard step-by-step procedure for handling numerical raw data and calculations.

This SOP package features a comprehensive step-by-step procedure that provides instructions for the construction, installation, and operation of a feed through assembly.

This SOP package features an SOP template that includes detailed instructions for the setup and operation of a PC-controlled, Kaye Validator 2000 system that are not available in the GE Sensing procedures.

This SOP package features a procedure for effectively planning and facilitating any meeting. Three universal templates to support meeting facilitation are also provided.

This SOP package features an SOP template that provides instructions for the setup, calibration, and operation of a pH/Conductivity Meter.

This SOP package feactures an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical freezer.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical incubator.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical refrigerator.

This SOP package features an SOP template that provides instructions for the setup, operation, and cleaning of a pharmaceutical ultra-freezer.

This SOP package features an SOP template that provides instructions for the setup and operation of SmartReader data loggers from ACR Systems.

This SOP package features a procedure that provides comprehensive instructions on creating comprehensive, effective, and clear Standard Operating Procedures in any industry.

This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Plans, which provide information on assays requiring transfer, activities related to assay qualification at the receiver site, as well as expected results and specifications.

This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Reports, which provide documented proof that transferred assays perform at the receiver's facility and in the receiver's hands acceptably and comparably with the sender.

This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product.

This SOP package features a procedure that provides comprehensive instructions on creating Experiment Reports, which document the details of an individual experiment or trial performed as part of a process transfer.

This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Plans, which outline, in detail, the strategies, activities, and timeline for transferring a process between different facilities, as well as provide expected results and specifications for the transfer.

This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Reports, which provide documented proof that a transferred process performs at the receiver’s facility and in the receiver’s hands acceptably and comparably with the sender.