current good manufacturing practices

Question 1

to ensure that minimum standards are met for drug product quality.

Answer 1

Current Good Manufacturing Practice (cGMP or GMP)

Question 2

Any component that is intended to furnish pharmacologic activity

Answer 2

Active ingredient or active pharmaceutical ingredient (API)

Question 3

specific quantity of a drug of uniform specified quality

Answer 3

Batch

Question 4

prove that the process has done what it purports to do for the specific batch concerned

Answer 4

batchwise control

Question 5

Documented testimony

Answer 5

Certification

Question 6

acting in accordance with prescribed regulations, standards, and practices

Answer 6

Compliance

Question 7

Any ingredient used in the manufacture of a drug product

Answer 7

Component

Question 8

A finished form that contains an active drug and inactive ingredients.

Answer 8

Drug product

Question 9

A batch or any portion of a batch having uniform specified quality

Answer 9

Lot

Question 10

Any distinctive combination of letters, numbers, or symbol

Answer 10

lot number, control number, or batch number

Question 11

The regulatory process through which industry measures actual quality performance, compares it with standards,

Answer 11

Quality control

Question 11

documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality

Answer 11

Quality audit

Question 11

activities relating to quality are being
performed adequately

Answer 11

Quality assurance

Question 11

A sample that accurately portrays the whole.

Answer 11

Representative sample

Question 11

Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product

Answer 11

Master Record

Question 12

responsible for the duties relating to quality control

Answer 12

Quality control unit

Question 13

area that is marked, designated, or set aside for the holding of incoming components prior to acceptance

Answer 13

Quarantine

Question 14

finished product or any of its components
is recycled through all or part of the manufacturing process.

Answer 14

Reprocessing

Question 15

concentration of the drug substance

Answer 15

Strength

Question 16

Signed by a second individual

Answer 16

Verified

Question 17

Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do.

Answer 17

validation

Question 17

evidence that a process (e.g., sterilization) does what it purports to do

Answer 17

Process Validation

Question 18

prospective experimental plan to produce documented evidence

Answer 18

Validation Protocol

Question 19

Deals with the responsibilities of the
quality control unit, employees, and
consultants.

Answer 19

ORGANIZATION AND PERSONNEL

Question 20

authority and responsibility for all functions

Answer 20

Quality control unit

Question 21

appropriate design and size and suitably located to facilitate operations

Answer 21

EQUIPMENT

Question 22

quarantine system to prevent their use in manufacturing and processing operations

Answer 22

Rejected components

Question 22

enable thorough cleaning, inspection, and safe and effective use for the designated operations.

Answer 22

Design and Construction Features

Question 23

In-process controls are of two general types:

Answer 23

Performed by production personnel Performed by the quality control laboratory personnel

Question 24

at the time of operation to ensure that the machinery is producing output within preestablished control limits

Answer 24

Performed by production personnel

Question 25

to ensure compliance with all product specifications

Answer 25

Performed by the quality control laboratory personnel

Question 26

Each label must contain:

Answer 26

o expiration date o production batch or lot number

Question 27

one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred

Answer 27

TAMPER-EVIDENT PACKAGE

Question 28

To ensure that a drug product meets applicable standard

Answer 28

EXPIRATION DATE

Question 29

quarantined in storage until released

Answer 29

Finished pharmaceuticals

Question 30

maintained for 1 to 3 years after the expiration date of the last lot of the drug product.

Answer 30

Reserve samples

Question 31

Computers are used extensively in plant operations such as:

Answer 31

o production scheduling, o in-process manufacturing, o quality control, and o packaging and labeling.

Question 31

must be maintained for at least a year following the expiration date of a product batch.

Answer 31

Production, control, and distribution records

Question 32

must be identified by lot number and product quality determined through appropriate testing.

Answer 32

Returned drug products

Question 33

must be produced in compliance with the cGMP regulatory requirements and standardized as to identity, purity, strength, and quality.

Answer 33

Clinical trial materials

Question 34

regulatory requirements are applied with flexibility.

Answer 34

during preclinical testing

Question 35

the manufacturer must produce a batch of the drug that is at least one-tenth the size of a commercial batch.

Answer 35

To demonstrate process optimization

Question 35

customization of a medication to fulfill the precise requirements outlined by the prescriber

Answer 35

Compounding