Pharmaceutical Manufacturing Terminologies Flashcards
Any substance or mixture of substance intended to be used in the manufacture of a drug product.
Active Pharmaceutical Ingredient
Substances which give a medicinal product it’s THERAPEUTIC EFFECT
Active Pharmaceutical Ingredient
An enclosed space with TWO OR MORE doors which is designed for people or goods
Airlock
A defined QUANTITY of starting material, packaging material or product processed in ONE PROCESS
Batch or lot
A DISTINCTIVE combination of number and or letters which IDENTIFIES A BATCH
Batch or lot number
Where do we put the slash? Number or letter O?
Number
Microorganisms are
Biological agents
Microorganisms include
Genetically engineered microorganisms
Cell cultures
Endoparasites
Any product completed processing stages but NOT FINAL PACKAGING
Bulk product
Set of operations UNDER SPECIFIED CONDITIONS. The relationship between values indicates by a measuring instrument or system.
Calibration
Corresponding known values of a REFERENCE STANDARD
Calibration
ENVIRONMENTAL CONTROL of particulate and microbial contamination
Clean area
Clean area is constructed to reduce
Introduction, generation and retention of contaminants
Has NO FILTRATION SYSTEM
Clean area
The action of CONFINING a biological agents
Containment
Area equipped WITH appropriate air handling and filtration
Contained area
It controls the introduction of potential contamination and consequences of accidental RELEASE OF LIVING ORGANISMS
Controlled area
System to be used for REPORTING or AUTOMATIC CONTROL
Computerized system
Contamination with ANOTHER MATERIAL
Cross contamination
Fresh or dried MEDICINAL PLANT
Crude plant
Liquefied gas at extremely LOW TEMPERATURE
Cryogenic vessel
Gas at a HIGH TEMPERATURE
Cylinder
DEPARTURE from an approved instruction
Deviation
Dosages form in FINAL IMMEDIATE PACKAGING
Drug Product
CONSTITUENT of a medicinal product
Excipient
The time the API is expected to remain WITHIN ESTABLISH SHELF LIFE SPECIFICATIONS
Expiry date
A medicinal product undergone all stages of production in it’s FINAL CONTAINER.
Finished product
Medicinal product contained active ingredients exclusively PLANT MATERIAL
Herbal medicinal product
A component which is NOT THE DESIRED ENTITY
Impurity
Contaminated with extraneous BIOLOGICAL AGENTS
Infected
Checks performed during production
In-process control
Partly processed material
Intermediate product
Purchase to distribution
Manufacture
A manufacturer should hold a
Manufacturing authorization
Plant for MEDICINAL PURPOSES
Medicinal plant
Substance for TREATING or PREVENTING disease
Medicinal product
Filling and labeling
Packaging
Description of OPERATIONS TO BE CARRIED OUT
Procedures
Receipt to packaging
Production
SUM TOTAL of the organized arrangements
Quality assurance
Ensures that APIs are of GOOD QUALITY
Quality assurance
CHECKING or TESTING if specifications are met
Quality control
STATUS of a product isolated
Quarantine
STARTING MATERIAL
Raw material
Removing or correcting products
Recall
A COMPARISON making sure allowance for normal variations
Reconciliation
Extensive set of analytical tests to be AUTHENTIC MATERIAL
Reference standard
REWORKING a batch of unacceptable quality
Reprocessing
SENDING BACK to manufacturer or distributor
Return
VEHICLE for preparation
Solvent
LIST of tests or references
Specification
Used in the production of medicinal product EXCLUDING packaging
Starting material
ABSENCE of living organisms
Sterility
PROVING in accordance with GMP leading to expected results
Validation
Based on PREVIOUS LABORATORY, PILOT SCALE or MANUFACTURING DATA
Expected yield
Which can have loss or error?
Expected or theoretical
Expected
ABSENCE of any loss or error
Theoretical yield
