Equipment Management
Primary equipment used in AS and the high level operation
What is equipment used to analyze samples?
Materials definition
What are raw materials including chemicals, solutions, reagents, excipients, resins, reference standards, assay controls or process intermediates that will be further processed before submission for analytical testing per SOP-420208.
What are access controls. Access to AR7 is controlled through BARS. Computer access is controlled and granted to PD staff through an IS ticket. Software access is controlled and granted through an IS ticket.
Data management in the area
What is "all data generated is electronic and handled per SOP-421699, ARI Process Development procedure for electronic data and system access"
Calibration and maintenance of equipment practices in the area
What is equipment labeled with Calibration/PM stickers OR due dates found in the Maximo system?
Temperature sensitive material handling
What is material control SOP-420208 details the receipt of materials
Primary tasks/functions for the area
What is analyze samples and report data. Sample can originate from ARI PD or network PD labs, QC labs and Manufacturing.
Ensuring Data Integrity
What are SOP-421699 details how to store electronic data, SOP-423444, Data Integrity Assessment Guidance for PD Equipment details requirements for data generated by Level A equipment, SOP-429669, HLEE procedure details how to handle paper based data.
Logbook/EUR practices in the area
What is "logbooks are in place as required per SOP-421274 and only required for user standardization activities. Logbooks are not required for activities tracked in the Maximo system"?
GMP Material handling
What is materials originating from a GMP source will not be returned to a GMP environment per SOP-420208.
Training requirements in the area
What is Training managed through the LMS systems and assigned based on role and level. APPX outlines required training for ARI PD. Method training is performed by a SME and documented in HLEE.
Data review/archival
What is SOP-430930, Archival, retrieval, storage and retention of controlled records and SOP-429669 HLEE SOP details review requirements.
Equipment labeling requirements in AS
What is "all equipment is labeled with a Maximo ID as required per SOP-421274"
Material and sample chain of custody procedures
What is material control defined in SOP-420208 requires expired materials to be discarded or labeled as expired with justification. Chemicals are tracked in the CRIS system from arrival to disposal. Sample chain of custody is defined per SOP-420929 and out of scope of the material control procedure.
Laboratory PPE
What are safety glasses, lab coat and safety shoes as defined in SOP-425651, ARI PD General Safety Guidance, Roles and Responsibilities and SOP-431458, ARI JHA Process Development Operations which details PPE required for certain tasks.
Alarm Notification and response process
What is SOP-421274, Process Development Asset Lifecycle Management SOP details requirements for OPT events and alarms
Shipping Process and controls
Unexpected results or exception process
What is SOP-429065 the Investigating Unexpected Results in Process Development procedure which outlines the process for handling unexpected results.