Tragic Events and Regulations
This book, written by Upton Sinclair, showcased the harsh realities of Chicago and industrialized cities in 1905, including exploitation of immigrants and deplorable conditions at the meat packing factories.
What is The Jungle?
This is the #1 Golden Rule of GMP operations.
What is "Follow the procedure"?
The "C" in ALCOA stands for this attribute of Good Documentation Practices (GDPs).
What is Contemporaneous?
Per SOP-0180, this is the maximum number of Read and Understand training tasks that a Trainee should complete in a single work day.
What is 10?
This term is used to describe the assessment of purchased materials upon receipt, before they are released for use in Manufacturing.
What is Inspection?
This President signed the Pure Food and Drug Act in 1906, which mandated annual licensure and inspections of vaccine manufacturing facilities.
Who is Theodore Roosevelt?
This is the voice that you should use to write instructions in your SOPs.
What is Active Voice?
This is the person who witnesses execution of the task/operation and verifies accuracy and completeness of the execution and acceptability of results, before proceeding to the next step.
Who is the Verifier?
Air is forced through this type of filter in the ceiling, and then directed down to the floor and exhausted through low wall air return vents to remove contaminants from the cleanroom.
What is a HEPA Filter?
Quality Control collects and analyzes these samples from the cleanrooms to provide assurance that contamination controls are effective.
What are Environmental Monitoring (EM) Samples?
In the 1960s, FDA Medical Officer Frances Kelsey refused to approve this popular sedative for use in the USA, which was subsequently known to cause severe birth defects in more than 10,000 babies worldwide when consumed by pregnant women.
What is Thalidomide?
These are the people you should notify if you can not find, do no not understand, or can not follow the written instructions, before proceeding.
Who are Area Management and QA?
This is Lyell's program for assessing the capability of our manufacturing processes to consistently produce an aseptic product.
What is Aseptic Process Simulation (APS)?
This is the tool that can be used to review training status and confirm that a Trainee has completed required training before performing the corresponding task.
What is the GxP Training Dashboard?
Hair, dirt, dust, and pollen are examples of this type of contamination.
What is Particulate Contamination?
In 1901, this tetanus-contaminated vaccine killed 13 children in St. Louis, Missouri.
What is Diptheria?
This is the maximum number of business days that should pass before initiation of a Deviation form, once it has been decided a Deviation form is required.
What is 1 Business Day?
This document is Lyell's standard for Data Integrity, which outlines the required conduct of Lyell employees to perform and document their work in an ethical manner, consistent with the ALCOA principles.
What is STD-0001?
These are the approved instructions in BMRAM that must be followed when performing maintenance and calibration of Lyell's equipment.
What is a Work Plan?
These are the critical controls and practices that are in place to reduce the risk of mixing up patient products.
What are Chain of Identity and Chain of Custody?
In 1937, S. E. Massengill Company used this solvent to create Elixir Sulfanilamide, which resulted in the death of 105 patients who used the antibiotic.
What is Diethylene Glycol (DEG) or Antifreeze?
MasterControl is used at Lyell to create approved SOPs. These are two other electronic systems used at Lyell to create approved instructions.
What are PAS-X and BMRAM?
SOP-0095 describes this process of creating an electronic copy of handwritten documentation.
What is True Copy Authentication?
This type of Training Course prompts the Trainee and their Manager to review and discuss completed training activities and documentation, and Sign Off only if both feel confident that the Trainee can perform the task independently going forward.
What is a Trainee Readiness Verification (TRV) Course?
This is a health condition that can result from being infused with cells that are contaminated with cells from another patient.
What is Graft Versus Host Disease (GVHD)?