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
The voluntary introduction of a specific excess during the manufacture of pharmaceutical forms of medicaments that are
unstable by nature
OVERAGE
ALLOWABLE OVERAGE
Dry Dosage Form
NMT 15%
ALLOWABLE OVERAGE
Liquid Dosage Form
NMT 20%
ALLOWABLE OVERAGE
Ointment
Suppositories
Aerosols
Creams
Foams
NMT 25%
ICH meaning
International Council for Harmonization
- STERILITY TEST
A. Primary Method
Membrane Filtration
- STERILITY TEST
B. Direct Transfer
DIRECT INOCULATION
Culture Media
-fungi, aerobic bacteria
SOYBEAN CASEIN DIGEST (TRYPTONE SOYA BROTH)
Culture Media
-anaerobes
FLUIDTHIOGLYCOLLATE
- TEST FOR PYROGENS
A. Bacterial Endotoxin Test
LAL Reagent
Two Methods of BET
- Gel Clot Formation & Turbidimetric Method
- (+) Formation of gel/dev of color presence of material endotoxins
Pyrogen Test
Dose:
10mL per Kg unless otherwise specified
Corticotrophin inj
Rat (either male or female)
COD Liver Oil
Rachitic rat
Vasopressin Inj
Male Rat
Chorionic Gonadotropin
Female rat (2-23 days old)
Digitalis
Pigeon
Glucagon
Cat
Oxytocin
Chicken
Heparin and Protamine
Sheep Blood Plasma
Parathyroid Inj
DOG
Insulin, Metocurine & Tubocurarine Inj.
Rabbit
Leaker’s Test
Dye:
1% Methylene Blue
Combination of attributes or characteristics of a product which, when compared to standard, serves as a basis for measuring uniformity of the product and determines its degree of acceptability
QUALITY
Refers to measure or step used to prevent or eliminate drug risks/hazards to make it safe and effective
CONTROL
Is a tool, which gives the assurance that a product conforms to standards and specifications through the system of inspection, analysis and action
QUALITY CONTROL
sum total of organized activities performed with the intent to ensure that all active pharmaceutical ingredients are of the quality required for their intended use
QUALITY ASSURANCE
process inside an organization with the aim to improve its performance by learning about good practices for primary and/or support processes through looking at those processes in other…
BENCHMARKING
A management approach for an organization centered on quality…
TOTAL QUALITY MANAGEMENT
Quality assessment with an attached judgement that the evaluated unit (programme or organization) is good enough to have the right to exist in a particular system
ACCREDITATION
A voluntary, non-treaty federation of standards setting bodies of some 130 countries.
ISO International Organization for Standardization
An undesirable characteristics of a product
DEFECTS
Unit of a product which contains one or more defects
DEFECTIVE
are ingredients intended for use in the manufacture of drugs and cosmetics, including those that may not appear in the final product
RAW MATERIALS
Assigned to each batch received from the supplier
RECEIVING NUMBER
Completed upon receipt of the material
Concerns the: QC, warehouse, purchasing, accounting
RECEIVING TALLY REPORT
Re-Assay Date
Vitamins, Flavorants
6 months
Re-Assay Date
Active Ingredients, Dyes
12 months
Re-Assay Date
Excipients
24 months
QC TEST FOR DF
-determines the material type, assembly, special properties and integrity
PACKAGING TEST
QC TEST FOR DF
-determines the physical & chemical reactions particular for the compound, gives the gross physical appearance
IDENTIFICATION TEST
QC TEST FOR DF
-determines presence of impurities: gross, chemical, and biological
LIMIT TESTS
QC TEST FOR DF
-determines conformance of DF when compared to label claim; this may be instrumental, chemical, or biological
ASSAYING
QC TEST FOR DF
-tests for properties, fx of particular DF
DF-Specific Test
Test for electronic Particle Counters
LIGHT OBSTRUCTION PARTICLE COUNT TEST
Test for Membrane Filtration
MICROSCOPIC PARTICLE COUNT TEST
Ideal size of particles
2um
amount of force necessary to redisperse
REDISPERABILITY
determines the repulsive forces bet particles
ZETA POTENTIAL
Contains 50 mg or more of an active ingredient comprising 50%
or more by weight of the formulation
WEIGHT VARIATION
Perform assay from pooled sample and calculate individual content of active ingredient in each of the 10 units
CONTENT UNIFORMITY
Defined as the state in which any residue of the unit remain on
the screen of the test apparatus or adhering to the lower surface
of the disk, if used, is a soft mass having no palpably firm core
COMPLETE DISINTEGRATION
Determine compliance with the dissolution paramaters for dosage form administered orally
DISSOLUTION
Friability maximum weight loss
FRIABILITY
Tablets must withstand the rigors of handling and transportation
experience in the manufacturing plant
HARDNESS
Measures the mechanical integrity of the tablet. It is the force that required to cause them to fail
BREAKING FORCE
Crushing Strength
HARDNESS
