Quiz Flashcards
A mechanism for DETERMINING and ASSIGNING necessary DUTIES to people so they can work together effectively
Organization
The basic element of an organization where the types of WORK just be identified and grouped logically on related elements
Division of responsibility
The basic tool that clearly defined the AUTHORITY, DUTY or RESPONSIBILITY
Position description
The organizational chart can
Assess strength and weaknesses in functions and personnel
It functions to INVESTIGATE CUSTOMER COMPLAINTS or inequities on the product
Central release section
SAMPLES retention or reserved samples withdrawn from the packaging line
Inspection and checking section
SOPs are written for the following except
Consumers information records
Examples of common product complaints except
Elegance
Stage of research which involves manufacturing requirements, reviews basic information, product control and patent application
Clinical research stage
Responsible for the conduct of STABILITY STUDIES
Chemical control and testing
Implies a procedure by which decisions are made regarding whether the production is processing as PLANNED
Monitoring
Ability of a particular formulation in a specific container to REMAIN WITHIN it’s physical, chemical, therapeutic and toxicological specification
Shelf-life
Cross contamination can come from the following except
Prevention of mix ups
The following are important document except
Batch records
To prevent microbial contamination contributed by people or is best to
Practice good personal hygiene
One for reason for inspecting the quality of the product during packaging and labeling operation is
To allow ease reconciliation
In the formulation of liquid, the following consideration should be studied except
Organoleptic characteristics
Used for mixing powder mixture in large volume quantity
V-blender
The IPQC test that determines the durability of a tablet and it’s ability to withstand abrasion in handling, packaging and shipment, USP requires a maximum weight loss of not more than 1%
Friability test
It is used for compacting the materials in the tablet machine
Punches
T/F
HEPA filters are used in the filtration of parenterals
F - air
T/F
Compressed gasses do not expand
F
T/F
Floors with easy to clean finish are made with troweled epoxy
T
Seamless surface can be achieved with heat - welded seams
T
T/F
Airlocks are used to maintain pressurized differentials between rooms
T
T/F
A pass through can be added through the airlock
T
T/F
Furnishings in the GOWNING room are made of non-shedding materials such as stainless steel
T
T/F
Gown racks can be equipped with HEPA filter above it to continually bathe garments in clean air
T
T/F
A personal lockers should be located separate from the clean GOWNING area
T
T/F
Restroom facilities can be located inside the GOWNING area
F
T/F
Materials and equipment can enter through the pass through
T
T/F
Personnel can communicate and transfer to another room in the pass-through
F
T/F
Windows can be placed in exterior building walls near a clean room
F
T/F
Windows should be impact-resistant type of glass or acrylic
T
T/F
The higher the pressure the CLEANER the room is
T
T/F
NON-UNIDIRECTIONAL airflow pattern is effective in removing particles in a clean room
F
