Vocabulary

Question 1

Act

Answer 1

the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.)

Question 2

Batch

Answer 2

a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture

Question 3

Component

Answer 3

any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product

Question 4

Drug product

Answer 4

a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo

Question 5

Fiber

Answer 5

any particulate contaminant with a length at least three times greater than its width

Question 6

Nonfiber releasing filter

Answer 6

any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered

Question 7

Active ingredient

Answer 7

any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect

Question 8

Inactive ingredient

Answer 8

any component other than an active ingredient

Question 9

In-process material

Answer 9

any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product

Question 10

Lot

Answer 10

a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits

Question 11

Lot number, control number, or batch number

Answer 11

any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined

Question 12

Manufacture, processing, packing, or holding of a drug product includes

Answer 12

packaging and labeling operations, testing, and quality control of drug products.

Question 13

Quality control unit

Answer 13

any person or organizational element designated by the firm to be responsible for the duties relating to quality control

Question 14

Strength

Answer 14

(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or
(ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

Question 15

Theoretical yield

Answer 15

the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.

Question 16

Actual yield

Answer 16

the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product

Question 17

Percentage of theoretical yield

Answer 17

the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage

Question 18

Acceptance criteria

Answer 18

the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).

Question 19

Representative sample

Answer 19

a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled

Question 20

Gang-printed labeling

Answer 20

abeling derived from a sheet of material on which more than one item of labeling is printed

Question 21

Acceptance Criteria

Answer 21

The criteria that a system or component must satisfy in order to be accepted by the user.

Question 22

Active Pharmaceutical Ingredient (API)

Answer 22

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Question 23

Automation Code Review

Answer 23

An iterative process carried out throughout the application code development effort, to systematically evaluate the code implementation against applicable requirements and standards, and facilitate identification and resolution of coding anomalies/ defects, deficiencies, and errors.

Question 24

BAS/BMS

Answer 24

Building Automation System/Building Monitoring System

Question 25

CFR

Answer 25

Code of Federal Regulations

Question 26

Cleaning Validation

Answer 26

Establishment of documented evidence which provides a high degree of assurance that specific cleaning process will reproducibly and consistently clean equipment meeting its predetermined specifications and quality attributes.

Question 27

Cleaning Verification

Answer 27

The process of sampling and testing to confirm that a piece of equipment is clean. Cleaning verification is not to be used in lieu of Cleaning Validation.

Question 28

Commissioning

Answer 28

Commissioning - A planned, documented, and managed verification approach to the start-up and turnover of facilities, systems, and equipment to the end-user / owner which results in a safe and reliable systems meeting established user and design requirements.

Question 29

Compliance Requirements

Answer 29

Any internal and/or external requirements necessary to comply with the applicable regulatory requirements. For example, the change request may include requirements for handling electronic records and signatures.

Question 30

Component

Answer 30

Any non-chemical material intended for us in the manufacture of a drug substance or drug product, including those that may not appear in such drug product. A component is any material that is consumable and is assigned a material number to allow for routine ordering.

Question 31

Continued Process Verification (Cleaning Monitoring)

Answer 31

Monitoring program for ensuring product contact equipment cleaned by means of a validated cleaning process remains in a state of control and is maintained in a validated state.

Question 32

Controlled Document

Answer 32

Written, approved documents used in association with GMP-related activities to ensure compliance with U.S. and international regulations, as well as company standards (GBL-QSTND-001 and GBL-QSTND-009)

Question 33

Control Limit

Answer 33

A limit representing the boundaries of inherent or natural variation of performance of a process or system. Values exceeding the control limit represent a change in performance with high probability. A control limit provides a statistical threshold to evaluate whether additional action is needed to bring the process or system back into control.