Types of Incidents
If the incident is determined to be category 1, do you have to escalate the incident to GEM?
No
In which GxP System are all the incidents/escalation registered?
1QEM
Who is the responsible to create the escalation record in the system?
A. Any Novartis associate that identify a potential incident
B. QA Responsible Organization.
C. Global Escalation Management
B. QA Responsible Organization
In a pharmaceutical manufacturing facility, a batch of a critical medication is being produced under strict GMP guidelines. During the manufacturing process, an operator accidentally adds an incorrect ingredient to the formulation, resulting in a potential quality deviation. Does the incident needs to be escalated?
Yes, the incorrect ingredient may impact the potency, safety, or stability of the medication, leading to potential patient harm if administered.
Who wrote the Odyssey?
Homero
Where are incidents commonly identified?
A) DEVs
B) OOS/OOE/OOT
C) Audits
D) Health Authorities Inspections
E) Complaints
F) All of the above
All of the above
In two working days an incident Cat 3 must be escalated?
Who determines the initial category of the incident?
QA Responsible Organization
Which category would you assign to this incident? (API concentration in tablets)
a. A routine quality control test revealed that the active pharmaceutical ingredient (API) concentration in a batch of tablets was below the specified limit, resulting in an OOS result.
Cat 3
What is the result of multiplication called?
Product
What is an incident that should be escalated?
Any event that impacts (or potentially) the following:
Quality, safety and efficacy of the product
Data integrity or misconduct
Compliance with regulatory requirements
Novartis reputation
Explain what is Day 0 in the incident/escalation process?
The day in which the incient was discovered. However, in some cases there may be not sufficient information inmediately upon “discovery” to categorize the incident. In these cases, the Day 0 for escalation may be the date the additional information is received, and the incident can be categorized. Rationale must be included in the documentation.
Who is the responsible to close the escalation record in the system?
A. Any Novartis associate that identify a potential incident
B. QA Responsible Organization
C. Global Escalation Management
C. Global Escalation Management
Patient picked-up 3 boxes of Salutex on 02-Feb-2024. The patient noticed that the information printed on the back of the box was incorrect. On the front of the box, it was written Salutex 20mg, the vial inside the box said Salutex 20mg, however the information on the back of the box for the excipients (non-medicinal ingredients) are for Salutex 10mg.
This complaint was received in the company, does the incident need to be escalated? Why?
Yes
a) Pharmaceutical products must accurately reflect their ingredients on the packaging to comply with regulatory standards.
b) Incorrect labeling can potentially lead to patient safety concerns
c) Escalating the incident allows for a thorough internal investigation to determine the root cause of the discrepancy.
What is the capital of Bosnia?
Sarajevo
Allegations of potential or confirmed data integrity issues related to GxP / Quality, Regulatory Affairs and Pharmacovigilance activities that are discovered through the SpeakUp office could be escalated? Justify
Yes
SpeakUp Office.-Review each SpeakUp complaint case within 24 business hours of receipt (business days, excludes weekends and holidays, e.g., 10
AM awareness of an incident on a Friday must be escalated by 10 AM the next Monday).
Select the incorrect answer: The escalation can be considered closed when?
o A) The investigation and associated root cause analysis have been completed
o B) CAPAs have been defined and approved
o C) All defined actions are pending to be initiated (notify Health Authority, market actions, change control, 3rd party notifications)
o D) Submit closure information in 1QEM
C. All defined actions have been initiated (notify Health Authority, market actions, change control, 3rd party notifications)
Which are all the roles involved in the escalation process?
A) Novartis Associate
B) QA Responsible Person
C) Global Escalation Management
D) Novartis Quality Leadership Team
A pharmaceutical company received a complaint from a patient who reported experiencing severe nausea and vomiting after taking a particular medication. The drug safety team reviewed the available data on the reported adverse effects and concluded that are side effects. Does the incident need to be escalated?
No, considering the known side effects and the absence of any other quality or safety concerns did not indicate any additional risks to patients.
In what year did the first human travel to space and who was it?
Yuri Gagarin in 1961
What is the time frame in which DI incidents must be reported to the relevant HA?
Credible DI incidents must be reported to the relevant HA in scope within 5 business days of Quality Management becoming aware of this incident.
Long term Health Authority Commitments: In which case supplementary records need to be opened to document follow-up activities in a timely manner?
1. Never since all the Health Authority notifications have actions closed in 1 month and are created as a child of the parent
2. If an HA commitment requires actions which are longer than a period of 3-6 Months.
3. If an HA commitment requires actions which are longer than a period of 1-2 Months.
2. If an HA commitment requires actions which are longer than a period of 3-6 Months.
Global GxP / Quality Incident Management prepares biweekly status update reports? Justify
False
Global GxP / Quality Incident Management prepares weekly status update reports
Novartis products were found in an area that informally accumulates garbage (an informal dumping ground). A visit to the site was coordinated to conduct an inspection and segregation of the products.
What category should be assigned? Justify
Category 2. After analysis, the incident has moderate severity and or potential impact
What are the 7 Wonders of the Modern World?
Chichén Itza, Christ the Redeemer statue, Machu Picchu, the Colosseum of Rome, Petra, the Taj Mahal, the Great Wall of China