MANUF LAB: M1 Lesson 4 (Definition of Terms)

Active Moiety

the molecule or ion responsible for the physiological or pharmacological action of the drug substance

Active Pharmaceutical Ingredient

a substance intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound

Adverse Drug Reaction

a response to a medicine that is noxious and unintended at doses normally used in humans

Batch

a defined quantity of material or product manufactured in a single or series of processes so it can be expected to be homogeneous

Batch Number

a distinctive combination of numbers and/or letters that specifically identifies a batch on labels

Biological Product

a product of biological origin prepared with biological processes and derived from human blood

Brand Name

the proprietary name assigned to the product by the Marketing Authorization Holder (MAH)

Contraindication

a statement regarding conditions wherein the use of the drug product may cause harm

Date of Manufacture

the date (month and year) during which processing of the bulk product is completed

Dosage

the quantity of a medicine given per administration

Dosage Form

the drug product type (e.g.

Drug Product or Drug

any article recognized in official pharmacopoeias

Dosage Strength

the concentration or potency of the active ingredient or active moiety in a formulation

Excipient

an ingredient added to the drug substance without pharmacological properties

Expiration Date

the date indicating the time prior to which a batch of product is expected to remain within approved specifications if stored properly

Formulation

the name

Generic Class Name

the identification of a drug product containing three or more APIs by its scientifically recognized name

Generic Name

the scientifically recognized name of the drug product's API

Indication

the FDA-approved clinical use of a drug based on scientifically supported evidence of safety and efficacy

Investigational Product

a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial

Label

the written

Labeling Materials

materials accompanying the drug product at the time of purchase

Lot Number

a distinctive combination of letters and/or numbers assigned to a specific lot of a batch

Manufacturer

an establishment engaged in production and final release of health products

Marketing Authorization (MA)

an official document issued by the regulatory authority for marketing or free distribution of a product after evaluation of safety

Marketing Authorization Holder (MAH)

the entity responsible for all aspects of the product

Mode of Administration

the manner and site of drug introduction or application to the body

Net Content

the total amount of dosage form in a drug product container

New Chemical Entity (NCE)

a new chemical or biological API not previously authorized for marketing

OTC Drugs

drug products that can be dispensed without a written order from a licensed physician or dentist

Pack Size

the quantity of dosage form in the final packaging of a drug product

Package Insert (PI)

a document supplied with prescription drug products intended for use by healthcare professionals

Patient Information Leaflet (PIL)

a document supplied with non-prescription drugs intended for patients

Pharmacologic Category

the classification of the drug product based on its therapeutic action

Precautions

instructions for special care in drug use to avoid undesired effects and ensure safe

Prescription Drug Products

drugs that require a written order from a licensed physician or dentist

Primary Label

the label on the primary packaging of a drug product

Prodrug

an inactive drug substance that must be converted into an active agent by metabolic or physicochemical transformation

Product Name

the name (generic and brand

Product Description

the complete organoleptic description of the finished drug product

Registration Number

a combination of letters and/or numbers assigned to a drug product by FDA as proof of registration

Small Containers

drug packaging materials holding ≤ 5 mL or 5 g (e.g.

Storage Condition

the specified temperature

Summary of Product Characteristics (SPC)

the product information approved by the regulatory authority for health personnel and consumers

Warnings

statements regarding potential hazards and undesirable effects associated with drug use

Drug Product or Drug

any article recognized in official pharmacopoeias

Drug Product or Drug

any article

Drug Product or Drug

any article intended for use as a component of any article specified in clauses (a)

Drug Product or Drug

herbal and/or traditional drugs of plant or animal origin used in folk medicine

Dosage Strength

the concentration of the active ingredient or active moiety in a formulation

Dosage Strength

the potency of the active ingredient or active moiety expressed in units by reference to a standard (potency determined by tests or clinical data)

Dosage Strength

stated in accordance with potency requirements of the monograph of the product as listed in official compendia (USP