manuf lab AO2016
the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as complex, chelate, or clathrate) of the
molecule, responsible for the physiological or pharmacological action of the drug substance.
Active Moiety
a substance or compound
that is intended to be used in the manufacture of a pharmaceutical
product as a therapeutically active compound (ingredient).
API
a response to a medicine that is
noxious and unintended, and which occurs at doses normally used in man
ADR
a defined quantrty of starting material, packaging material or
product manufactured in a single or series of processes so that it can be
expected to be homogeneous
Batch
a distinctive combination of numbers and/or letters
which specifically identifies a batch on the labels, the batch records,
and the certificates of analysis, etc.
batch number
any product of biological origin, prepared with
biological processes, derived from human blood and plasma, or
manufactured by biotechnology, consisting of substances of higher
molecular weight whose purity, potency, and composition cannot
readily and reliably be determined by chemical or physicochemical analysis
Biological Product
the proprietary name assigned to the product by the
Marketing Authorization Holder (MAH)
brand name
a statement regarding the conditions wherein the use
of the drug product may cause harm to the patient
contraindication
the quantity of a medicine gtven per administration.
dosage
the drug product type (e.g.tablet, capsule, solution,
cream) that contains a drug substance generally, but not necessarily, in
association with excipient(s).
dosage form
an ingredient, added intentionally to the drug substance
which should not have pharmacological properties in the quantity used.
excipients
the name, strength, and reference monograph of all APIs
and/or excipients present in the drug product.
Formulation
the identification of a drug product containing
three or more APIs by its scientifically and internationally recognized
name or by its official generic name as determined by FDA.
Generic Class Name
the identification of a drug product by its scientifically
and internationally recognized API or by its official generic name as
determined by FDA.
Generic Name
the FDA-approved clinical use of a drug product based on
substantial, scientifically supported evidence ofits safety and efficacy
in the given dosage form.
Indication
a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing autharization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Investigational Product
an official document issued by the competent drug regulatory authority (DRA) for the purpose of marketing or free distribution of a product
Marketing Authorization
the manner and site where the drug product
is to be introduced into or applied on the body.
Mode of Administration
the total amount/quantity/number of the dosage form in a
certain container of a drug product expressed in metric system.
Net Content
new chemical or biological API not
previously authorized for marketing for any pharmaceutical use in the
country in question.
New Chemical Entity
refers to the quantity of dosage form in the final packaging
(excluding the shipping carton) of a drug product bearing the required
labeling information.
Pack Size
the document defining information that is
supplied with prescription drug products by the MAH.
package insert
the document defining information
that is supplied with non-prescription drug products by the MAH.
Patient Information Leaflet (PL)