Introduction to Olgam Life
What is cGMP?
SOP: CTR1000 Introduction to Plasma
Current Good Manufacturing Practices
What does Universal Precautions mean?
SOP: CTR8000 Bloodborne Pathogen and Exposure Control Plan
Treating all biological products as if they are contaminated.
What is center management responsible for?
Center Management is responsible for the overall daily operations and upkeep of the center and of eDMS.
Who is responsible for hosting center audits?
Center Quality, Corporate Personnel may be present.
Define concurrent documentation.
SOP: CTR1000 Introduction to Plasma
Contemporaneously complete the required task and document the required details to ensure accuracy.
What are the cGMP personnel requirements?
SOP: CTR1000 Introduction to Plasma
What is considered PPE?
SOP: CTR8000 Bloodborne Pathogens and Exposure Control Plan
Equipment includes but is not limited to gloves, lab coats, face shields, and eye protection.
What is center quality responsible for?
Center Quality is responsible for the oversight of center activities, ensuring that those activities have been performed in compliance with all SOPs.
True or False: If an auditor asks you a question that you do not remember the answer to, it is acceptable to say, "I don't know. Let me refer to the SOP to verify that answer."
SOP: CTR9002 Audits
TRUE
How are employee donors identified in NexLynk?
Who is responsible for completing this activity?
SOP: CTR1011 Employee Donor Policy
Employee donor note
Center Management
What is Falsification?
SOP: CTR1000 Introduction to Plasma
A major violation of company standards and is illegal, and placed employees, donors, and patients at significant risk of harm.
When do gloves need to be replaced?
SOP: CTR8000 Bloodborne Pathogen and Exposure Plan
When contaminated, torn, punctured, or when their ability to function as a barrier is compromised.
What is an MQSR?
SOP: CTR9000 Plasma Center Leadership Oversight Overview- QA and OPs
Monthly Quality System Review
State how to capture and document a donor complaint in NexLynk.
SOP: CTR9008 Complaints
Navigate to the donor chart, navigate to donor notes, document new donor complaint note.
How long must an employee wait until they are permitted to donate with Olgam Life?
SOP: CTR1011 Employee Donation Policy
30 days from employment
What is the temperature requirement for storing Source Plasma?
SOP: CTR1000 Introduction to Plasma
Stored at -20 degrees C or colder
What type of Safety Controls are utilized at each center?
SOP: CTR8001 Hazardous Communication
- Engineering Controls
- Work Place Controls
- Housekeeping Controls
- Personal Protective Equipment (PPE)
Describe the center's management coverage requirements.
Center Management is required to be on-site during all operating hours, beginning in the morning during equipment calibration activities and ending when the last employee has been released from duty after center production has been completed.
Which agencies may present at a center to conduct an audit?
FDA, OSHA, PPTA, CLIA
State why following line clearance manufacturing practices are important.
SOP: CTR1000 Introduction to Plasma
This process prevents mislabeling or cross-contamination of finished products helping to ensure donor and patient safety.
Define line clearance.
SOP: CTR1000 Introduction to Plasma
The standardized procedure in manufacturing for ensuring equipment and work areas are free of products, documents, and materials from a previous process.
How do you properly clean a blood spill?
SOP: CTR8000 Bloodborne Pathogens and Exposure Control Plan
- The individual cleaning the blood spill must be in PPE
- Collect all necessary materials
- Spray the blood contaminated surface with a 1-10 solution of bleach and water or a chemical disinfectant
- Allow larger spills to sit for 15 minutes
- Absorb and remove all traces of the spill with paper towels or other acceptable materials
- Re-spray the cleaned area with the bleach solution and all to air dry
Describe the center's quality coverage requirements.
Center Quality is required to be on-site when operational activities occur that are the direct responsibility of center quality.
What is a form 482?
What is a form 483?
SOP: CTR9002 Audits
Form 482: A Notice of Inspection, which is always provided by the FDA inspector at the start of the inspection.
Form 483: A Notice of Inspectional Observations, which is only provided if the auditor has a major observation noted during the inspection.
What Relevant Transfusion Transmissible Infections (RTTIs) are tested for on each donation?
SOP: CTR1000 Introduction to Plasma