https://padlet.com/llleras20/hytf6x32rf5r Write a list of responsibilities your group will have under a GLP study even if they are not any different than what you are currently doing. Indicate at the top, your group's name, i.e. LC Lab, SM, ASM, QA, etc. See QA example. To respond to this question, left click on the plus sign (+) on the lower right corner. First, input your lab or work area then enter to start jotting down your response. en-us 2018-10-03 18:11:48 UTC 2019-09-23 13:22:15 UTC hello@padlet.com llleras20 https://padlet.com/llleras20/hytf6x32rf5r/wish/288813469 Review protocol
Maintain GLP study master list

]]> 2018-10-03 18:12:35 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/288813469 https://padlet.com/llleras20/hytf6x32rf5r/wish/291879134 Monitoring of equipment, personnel, methods, practices, records and controls to ensure they are in conformance with the regulations.
Independent of testing.
Maintains copy of Master Schedule and Protocols.
Inspect at reasonable intervals.
Oversee deviations.  ]]> 2018-10-11 17:52:54 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/291879134 https://padlet.com/llleras20/hytf6x32rf5r/wish/297947029 Establish well-documented practices and procedures. [Roles; Storage; Facility; SOP's]

Establish protocols for studies. 

Authorize protocol deviations, and determine magnitude of impact.

Approve protocols/SOP's/WI's/Tables/Forms




]]> 2018-10-29 11:28:09 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/297947029 https://padlet.com/llleras20/hytf6x32rf5r/wish/385974653 LC Lab: GLP study.
(Prior to study- a GLP study notebook freeform is given to LC lab from QA)
1. An email is sent to group that GLP study in-house.
2. Make all personnel aware and ensure all have read the Protocol.
3. The personnel ensures all instrumentation, standards, etc are within expiry for the test. Tests are scheduled.
4. Test are performed under the Protocol and Methods referred to in the Protocol. Note any exceptions or anomalies immediately. Prior approval from client may be deemed necessary to proceed with a specific test.
5. Once tests are completed and first reviewed, they are handed to the LC Data Review Specialist. 
6. The data packet, all associated notebooks are reviewed. The protocol and documents from sample management and project manager are reviewed for data accuracy.
7. All lines requiring signatures/dates are completed as well as the GLP study notebook.
8. Should there be any clarity needed or data review questions, the reviewer speaks with the analyst, technician and chemist.
9. Any notations or comments is brought to the attention of the Group Leader. He/she may need to further investigate or confir with the project manager. 
10. Once data is sufficiently reviewed, and chromatography is deemed acceptable from the review, the Final Report Checklist used by the LC lab (RJRT-FM-001974 current revision) will be signed off by the data review specialist. The report will be returned to the chemist who completed the data pack.]]> 2019-09-18 14:30:36 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/385974653 https://padlet.com/llleras20/hytf6x32rf5r/wish/385981193 1. Inform group that there is a GLP study. 
2. Assign someone to the study. 
3. Make sure involved parties read protocol and sign. 
4. Maintain proper paper trail for the lab for the GLP study. 
5. Ensure all materials, standards, reagents, and instruments are within expiry for the study. 

]]> 2019-09-18 14:38:18 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/385981193 https://padlet.com/llleras20/hytf6x32rf5r/wish/386162319 Ensure all equipment, instrumentation, standards, reagents, etc. to be used are within the proper expiration dates for the tests.

Make sure all tests are done according to approved protocols and methods.

Ensure all data has been recorded properly with all necessary reviews and signatures. ]]> 2019-09-18 18:23:17 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/386162319 https://padlet.com/llleras20/hytf6x32rf5r/wish/388142669 1. Notification of GLP study
2. Prioritize TRACEABILITY
3. Ensure that all involved personnel have read and been trained on the Protocol.
4. Make sure that appropriate notebooks have been requested and are incorporated in labs
5. All equipment & instrumentation is listed, remain calibrated, and maintenance logs are kept.
6. Ensure that the protocol is followed
7. Make sure that good documentation practices are being followed, especially deviations
8. All recorded data is documented, signatured, and reviewed.

]]> 2019-09-23 13:13:53 UTC https://padlet.com/llleras20/hytf6x32rf5r/wish/388142669