When is inspection of equipment for cleanliness done?
100
In chronological order
How are entries to be made in logbooks?
100
Purpose, Scope, Responsibilities, Key Words & Definitions
What sections must a PPG contain?
100
Everyone needs this.
What is education, training and experience or a combination thereof to performed their assigned
function(s)?
100
This functional group approves specifications, standards, sampling plans and testing plans.
What is Quality Assurance?
200
Done with previous batch information on equipment
What is removal and/or obliteration?
200
What was sent, the Quantity, Who sent to, Where sent to and When sent.
What should distribution records of drug product include?
200
Three years
What is the required review period for a PPG?
200
Functional Group responsible for approving or rejecting raw material, finished products, containers and closures. Also responsible for approving or rejecting procedures or specifications.
What are Quality Assurance/Quality Control?
200
These equipment and instruments are not used.
What is not meeting established specifications?
300
A unique number.
How is equipment identified?
300
Name of supplier, supplier Lot #, receiving code, date received and results of testing.
What should component, container, closures and labeling records contain?
300
Amount of time to complete training on a revised PPG.
What is within 30 days from the effective date?
300
You need training in these.
What are cGMP and written procedures as they apply to your job?
300
Laboratory controls which are required to be established and written.
What are specifications, standards, sampling plans and testing plans?
400
Documents the responsibility for cleaning, cleaning and maintenance schedules, methods to clean and the protection needed once cleaned.
What should the written procedure/SOP for equipment contain?
400
Name and Strength, Dosage form, complete list of components, theoretical reconciliation.
What should be included in Master Batch Records?
400
The only two signature format acceptable according to PPD-SOP-1139.
What are handwritten and electronic?
400
Labcoats, gloves, hair coverings, safety glasses.
What are protective apparel that are appropriate for the duties to be performed and to protect the drug product from contamination?
400
The minimum amount of material which much be reserved to perform all required tests, except for sterility.
What is twice (2x)the amount?
500
Can change product and control records on computer or related systems
Who are authorized personnel?
500
Prepared by one person and checked by another.
How are Master Batch Records be to prepared?
500
PPD-SOP-1000-F4-01
What is the PPG Form used to create, revise or retire PPGs and names the review group?
500
Name, address, qualifications and the type of service they are providing.
What records need to be maintained for a consultant?
500
These testing controls have to be validated for Accuracy, Sensitivity, Specificity, and Reproducibility.