Laboratory
Production
Qualification & Validation
Quality Management
Potpourri
100
T / F Sampling of Starting Material can be done directly in the warehouse
What is False, sampling must be done in a protected area
100
T/F One person is cleaning the equipment and the GMP requires a second person to verify that the person used the right cleaning agent
What is False, GMP requires that the second person verify that the equipment is clean
100
T/F A company can exclude laboratory equipment from their validation master plan
What is False, complex and computerized lab equipment also need qualification and validation
100
The "c" in CGMP stands for this
What is current
100
The form 483
What is the form used by the FDA to write audit findings on
200
T/F It is a requirement to have written procedures on how to prepare standard solutions in the lab.
What is True a procedure is required
200
The number of supervisors required in accordance with GMP for a plant with 100 production workers
What is Sufficient
200
The difference between qualification and validation
What is equipment is qualified and processes, systems, and methods are validated
200
The time in which data should be registered into the records
What is at the time of performance (Contemporaneously)
200
Changes should not be implemented until all necessary approvals have been obtained and change control is in “BLANK” status.
What is Pending Change
300
Four items that should be recorded in an instrument log book
What is usage, calibration, cleaning, maintenance, date, time, signatures
300
The three most common levels of water quality used in Pharmaceutical manufacturing
What are WFI (water for Injection), Purified water, distilled water, De-ionized water, RO-water
300
the purpose of doing Internal Audits
What is a way for the company to identify that the organization follows appropriate GMP and adhere to internal procedures and to monitor improvements
300
The total number of SOP's in the vendor approval process
What is 12
400
Three things that should be included in a sampling procedure
What is the method, the equipment to use, the amount of sample, type of sample container, how samples shall be identified, any precautions, storage instructions, cleaning and storage of sampling equipment.
400
During production, equipment shall be identified with some specific information
What are the product, the batch identification, and what phase of production
400
The meaning of preventive maintenance
What is to establish a maintenance program that prevents the equipment from malfunctioning to breaking down
400
In addition to internal audits give two other common areas that are auditied
What are suppliers, contract manufacturers, and contract laboratories
400
The acronym ALCOA
What is Attributable, Legible, Contemporaneous, Original, Accurate
500
The purpose of the requirement for an ongoing stability program
What is to monitor the product over it's shelf life and to make sure the product does not age quicker than expected.
500
The difference between contamination and cross-contamination
What is contamination involves unwanted substances from external sources such as dust or particles while cross-contamination involves residues from another drug
500
The three design requirements on production equipment
What are shall not react with the product manufactured, shall not absorb or leak anything from or to the product, and shall be easy to clean
500
The abbreviations QA, QC, & QP stand for this
What is Quality Assurance, Quality Control, & Qualified Person
500
Major and critical equipment for production is normally given an identification number. When the equipment is used, where shall this number be recorded
What is the batch record
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