ANALYSIS 2 | Part 1 Flashcards
The basic document from where the master formula and batch
production records are based
MANUFACTURING MONOGRAPH
CGMP OR AO___
AO No. 220 s. 1974
The document which provides the basis for accepting the quality of each and every component used in the manufacture of the
product in accordance with the specifications and methods
QUALITY CONTROL MONOGRAPHS
The document generated to explain in detail the reason behind a
procedure and proper sequence of steps to be done, and how
equipment are to be operated for maximum performance
STANDARD OPERATING PROCEDURES
-The original document used as the key in the manufacture of
products
-Being the prototype, it is kept in a secured documentation room,
MASTER FORMULA RECORD
is an accurate reproduction of the master formula record
-After being used as the guide to production and actual data of what has been done are recorded therein
BATCH REPRODUCTION RECORD
Specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture
BATCH
A batch, a portion of a batch, or a
combination of batches
LOT
-Should be identified as such on the label
- Differences in format and content of batch
production records from
Control codes
Any distinctive combination of marking, letters, or numbers by which the history of the manufacture and control of a batch or lot of a product can be determined (e.g., for documentation and
product recall)
BATCH NUMBER, LOT NUMBER, CONTROL NUMBER
tests are performed to
determine if the product meets specifications throughout the
entire processing and particularly during critical stages of manufcaturing
IN-PROCESS CONTROL
Minimum attributes common to general categories of products are enumerated below. Where necessary, some of these tests are performed during processing (IPQC) of the product and
repeated in the final product
CONTROL TESTS
All operations, including filling and labelling, which a bulk product
has to undergo in order to become a finished product
PACKAGING
Tool for determining error and wastage, as well by comparing
actual yield (AY) and theoretical yield (TY)
MATERIAL RECONCILIATION
-The procuring, purchasing, holding, storing, selling, supplying,
importing, exporting, or movement of pharmaceutical production
DISTRIBUTION CONTROL
_____ and ____ should be withheld until batch
certification from FDA is received
Antibiotics and Insulin
Aids in the monitoring of stocks either received or dispatched
STOCK CARDS
-The ability of a particular formulation in a specific container or closure system to remain within its physical, chemical, microbiological, therapeutic, and toxicological specifications or best state
STABILITY
The period of stability of a preparation is the time from the date
of manufacture of the formulation until its chemical or biological act and is _____ of the labelled potency
NLT 90%
Duration of time during which the drug prep will remain stable
SHELF LIFE
Limits the period during which a preparation may be expected to have its labeled potency
EXPIRATION DATE
TYPE OF STABILITY STUDIES
For 3 mos, use of exaggerated conditions
SHORT TERM / ACCELERATED STABILITY STUDIES
TYPE OF STABILITY STUDIES
For 2 YEARS, normal conditions, makes use of climatic zone
LONG TERM / REAL TIME STABILITY STUDIES
TYPE OF STABILITY STUDIES
For 6-12 months, involves 10 deg increment of those in ASS
STRESS TESTS
