GSDP
What is the ISO international standard that specify the requirements for Quality Management System (QMS)
ISO 9001:2015 or ISO 9001
The degree to which data are complete, consistent, accurate, trustworthy, reliable, and that these characteristics of the data are maintained throughout the data life cycle.
Data Integrity
This is an unplanned event that could have caused damage, injury, or death but was narrowly avoided.
Safety Near Miss / Near Miss
How many pillars of Sustainability does ZP recognize?
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance
It is a comprehensive written contract between parties involved that defines and establishes each party’s quality responsibilities.
Quality Agreement
ALCOA principles were expanded to ALCOA plus with 4 added Data Integrity principles
These are Complete, Enduring, Available and ____________.
Consistent
What is the most common type of hazard in workplace?
Physical hazard
It is the ISO standard intended for use by organizations seeking to manage its environmental responsibilities.
ISO 14001
During receipt of AE report, it is possible to receive incomplete information. However, once we have these 2 minimum required details, the AE can already be forwarded to the Client.
One of these information is the description of the Adverse Event. What is the other required information?
1. AE description
2. ____________?
Product details/ product name and batch number
It is a fundamental tool in the quality system that aims to analyze information, effectively investigate deviations, and take appropriate measures to avoid recurrence as well as occurrence of potential Deviation.
CAPA
A form of metadata containing information associated with actions that relate to creation, modification, deletion of GxP records in a computerized system.
Audit Trail
Engineering controls, Substitution, Elimination, Administrative, and PPE are safety controls to reduce or eradicate safety risks.
Among these controls, which type is the most effective?
Elimination
This concept seeks to reduce waste by re-using the resources for as long as possible and recover the resources at the end of a product's life
Circular Economy
It is defined as an unintended failure in the drug treatment process that leads to or has the potential to lead to harm to the patient.
Medication Error