Show:
Organization & Personnel
Buildings and Facilities
Equipment
Controls
Potpourri
100
Responsible to release quarantine drug products.
What is the quality control unit/quality assurance
100
Any building used in the manufacture, processing , packaging or holding of a drug product must be kept in this state.
What is maintained in a good state of repair?
100
This must be designed, suitability located and of adequate size to do the job it was intended for
What is equipment?
100
Where components, drug product containers and closures are stored until they have been tested/examined
What is "under Quarantine"? (Quarantine area)
100
The drug product in the same container-closure system as that in which the drug product is marketed.
What is a requirement of stability testing
200
Quality Assurance/Quality Control are required to have these.
What are written procedures?
200
Lighting
What needs to be adequate and provided in all areas?
200
These must be done to prevent contamination of equipment and utensils.
What are cleaned, maintained and sanitized?
200
Bagged components drug product containers and closures need to be stored in this manner.
What is off the floor and suitably spaced to prevent contamination?
200
The Act that cGMP fall under.
What is the Food Drug and Cosmetic Act?
300
You need training in these.
What are cGMP and written procedures as they apply to your job
300
Potable Water needs to meet this Agency's standards.
Who is the Environmental Protection Agency (Primary Drinking Water Regulations 40CFR Part 141)?
300
Responsibility for cleaning, cleaning and maintenance schedules, methods to clean and the protecting once cleaned.
What does a written procedure/SOP for equipment need to contain?
300
Complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays.
What are laboratory records?
300
This testing must be done if the potential for cross contamination exists.
What is test the non-penicillin drug product for presence of penicillin?
400
These may be excluded you from direct contact with containers, closures, drug product and testing until your condition is corrected.
What are any illness or injuries (open lesion)? quality or safety of a drug product.
400
Sanitation and maintenance procedures apply to these people.
Who are contractors, temporary employees and full-time employees?
400
These are equipment records that are required to be kept.
What are maintenance, cleaning, sanitizing and inspecting?
400
These show that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
What do the initials or signature of a second person mean?
400
Should be informed of serious and unexpected adverse drug experiences.
Who is FDA?
500
The type of service they are providing.
What records need to be maintained for a consultant?
500
These constitute adequate washing facilities.
What are hot and cold water, soap or detergent, and air driers or single service towels?
500
Storage of quarantine material, storage of released material, Storage of in process material, or packaging and labeling operations
What operations are performed within specifically defined seperate areas?
500
Test methods employed by the firm for testing and release for distribution need to have these established characteristics.
What are accuracy, sensitivity, specificity, and reproducibility?
500
The amount of reserve sample that must be retained for a drug product.
What is at least twice the amount needed necessary to perform all required tests except those for sterility and pyrogens