Validation document and Standard Operating Procedure (SOP) Creation of Incubator Shaker for Vial Thaw and Shake Flask Manufacturing Operations

This Semester-in-Residence project was conducted at Gilead Sciences, Biopharmaceutical Company, in Oceanside, CA within manufacturing department. The goal of the project was to generate User Requirement Specifications (URS), Standard Operating Procedure (SOP) and Installation Qualification/Operational Qualification (IQ/OQ) documents for Incubator Shaker validation. Equipment validation is one of the most important activities that need to be performed prior to equipment operation in a cGMP setting. The first step of the validation process is to create documents that are required to perform validation. New incubator shakers are being validated at Gilead Sciences, and URS, SOP and IQ/OQ documents need to be created prior to validation. URS is needed to identify the minimum requirements of incubator shakers with respect to the functionality and operating environment in which the incubator will operate. A SOP is required to give specific instructions to operators for robust operating processes, while IQ/OQ document is necessary to confirm the minimum installation and operational requirements of incubator shakers. Overall, URS, SOP and IQ/OQ documents for the incubator shakers were generated successfully. All the documents were reviewed and approved by personnel from manufacturing, validation, engineering and quality assurance department. URS and SOP are ready to be used as supporting documents for validation, and IQ/OQ document is ready to be executed to complete validation process in cGMP environment. Recommendations for future work include the implementation of remote alarms and the execution of IQ/OQ documents.