'GxP' Basics
This term covers Good Manufacturing, Laboratory, Clinical, Distribution and Pharmacovigilance Practices.
What is GxP?
This four-letter acronym addresses the root cause of a quality problem and prevents its recurrence.
What is CAPA (Corrective and Preventive Action)?
The Insmed learning management system (LMS) platform where employees complete and track their training assignments.
What is Insight?
In 1982, a tampering incident with this product and company led to strict packaging regulations across the pharmaceutical industry.
What is Tylenol / Johnson & Johnson?
Insmed's first and only FDA-approved product, used to treat MAC lung disease.
What is ARIKAYCE® (amikacin liposome inhalation suspension)?
It's the foundational data integrity framework in the biotechnology industry used to ensure that all records are reliable, traceable, and compliant with Good Manufacturing Practice (GMP).
What is contemporaneous documentation (ALCOA)?
The acronym for the regulatory framework governing the conduct of clinical trials.
What is GCP (Good Clinical Practice)?
Insmed tracks this training metric monthly.
What is on-time completion?
This major recall type is classified as the most serious by the FDA, indicating the product may cause serious adverse health consequences or death.
What is a Class I Recall?
Insmed's five core values, recited at the close of every email signature.
What are Collaboration, Accountability, Passion, Respect, and Integrity?
Under GxP, this document type describes the step-by-step process for performing a specific task.
What is a Standard Operating Procedure (SOP)?
After a CAPA is implemented, this two-letter acronym is the step that verifies the action was effective.
What is an EC (effectiveness check)?
These Insmed employees serve as liaisons to the Training Team and assess which training documents should be added to department curricula.
What are Department Champions?
The 1990's generic drug scandal compromised this quality.
What is data integrity?
This Outlook tool is trained via a video course and helps users report suspicious emails.
What is the Phishing Alert Button?