Quality System Manual
This Company designs and manufactures sustained-release injectable drug products.
What is SpineThera
The c in this acronym denotes current to industry standard
What is cGMP
The four main sources of cleanroom microbial contamination are raw materials, room air, room surfaces and _ _ _ _ _
What is water?
This form is used to manage new and revised documents
What is Document Change Record?
True or False
Personnel exhibiting illness or infection may enter cleanroom
What is False?
This unit is responsible for coordination of the quality management system
What is the Quality Unit
The principles of this acronym are understood and applied, where records must be attributable, legible, contemporaneous, original and accurate
What is ALCOA
The most common microorganism found in cleanrooms are transient to human skin and are spread by touching, sneezing and _ _ _ _ _ _ _ _
What is coughing?
True or False
Records printed outside the office must be destroyed upon returning to the office by shredding or be given to Quality to destroy
What is true
Unplanned events are handled per what procedure
What is Quality Event Procedure?
They are responsible for adherence of the regulatory requirements, quality system manual, policies and principles
Who are SpineThera personnel
FDR signed the Food, Drug, and Cosmetic Act in this year, which brought cosmetics and medical devices under control
What is 1938
True or False
Disinfectants do not necessarily kill bacterial spores
What is True?
True or False
Document revisions are tracked by sequential numbers
What is False
Gloves must be sanitized when moving from which two class types
What is Class D to Class C?
This is used to test products or systems, or used to support the systems used to manufacture or test product shall be appropriately qualified
What is all equipment
Controlled, pre-approved procedures are an example of what
What is Say What you do?
The most critical concern during gowning is to minimize contamination from getting on what part of the garment
What is outside?
A document is considered this when it is promptly removed and archived as not to be used
What is obsolete
Pressure and Temperature documentation is an example of thy type of entry
What is "Entry Only"?
This document is the primary reference document for the Quality System
This organization sets standards for the manufacturing and distribution of medications, food ingredients and dietary supplements and has a yearly publication
What is USP (United States Pharmacopeia)
Most bacteria isolated from cleanroom are this type (requiring oxygen)
What is aerobic?
This is a comprehensive log of all changes to effective documents
What type of training and evaluation is required prior to entry into the cleanroom
What is live trial gowning?