LAS 1 Flashcards
Any component which is intended to furnish PHARMACOLOGICAL ACITIVTY
Active ingredient
A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacturing
Batch
A designation of number or letter or combination thereof that identifies the batch
Batch number
ANY MATERIAL INTENDED TO BE USED FOR THE MANUFACTURER OF A PRODUCT, whether raw materials or packaging materials
Component
intended to be rubbed, poured, sprinkled, or otherwise applied to the human body or any part thereof, for cleansing and beautifying
Cosmetics
The date INDICATING THE START OF BATCH PROCESS
Date of manufacture
The activity of weighing, counting, or measuring and checking of starting materials and issuing these materials to the appropriate production personnel
Dispensing
Any substance/s in a finished dosage form that IS OFFERED FOR SALE
Drug product
A product that has undergone ALL STAGES OF MANUFACTURING OPERATIONS.
Finished product
A date fixed for each individual batch on or before which that batch is expected to meet the standard specifications for quality, safety, and efficacy
Expiration date
It is the SYSTEM OF QUALITY ASSURANCE aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use.
Good Manufacturing Practices
Any processed substance or mixture of substances which have to undergo a few step before finished product
Intermediate product
a batch or any portion of a batch of a drug or, in the case of a drug produced in a unit of time or quantity in a manner that assures its uniformity and quality within specified limits
Lot
The COMPLETE set of activities to produce a drug
Manufacturing
It is an INSTRUCTION TO PRODUCTION to produce a drug
Manufacturing order
The standard from where manufacturing order is derived
Master Formula
The process of packaging
Packaging
The description of the operations to be executed
Procedures
The part of the production cycle from weighing of raw materials to finished product
Processing
All control measures designed to ensure that finished products consistently condor, to established specification of identity, purity, strength and quality
Quality control
An act of holding off material for use; Pending a decision on release or rejection
Quarantine
All substances whether active or excipients that are employed in the processing of a finished product
Raw materials
The status of materials or products which are NOT PERMITTED to be used for processing, packaging or distribution
Rejected
The status of materials or products which are PERMITTED to be used processing, packaging or distribution
Accepted
a SAMPLE REPRESENTING the lot, the batch, or the total amount of materials based on a sampling plan
Representative sample
Any finished product which is already in distribution and sent back to the manufacturer or distributor due to a complaint.
Returned products
Raw materials used in the production
Starting materials
the quantity that is EXPECTED to be obtained at any phase of production based on the quantity of components
Theoretical yield
Any processed material which has to undergo another process including packaging operation to become a finished product
Bulk product