MODULE 3 Flashcards
It is a CGMP requirement that all raw materials, active or
inactive, be assigned a meaningful reassay date that
assures the purity and potency at the time of use.
Raw Materials
A date of retest.
Re-assay Date
Monthly or prior use
Highly unstable materials
24 months
Active ingredients and excipients
12 months
Active ingredients and dye
6 months
Vitamins and flavors
A definite working rule
regarding size and frequency of sample and
the basis for acceptance or rejection.
Sampling
It is a specification of sampling.
Sampling
Refers to lot or batch from which the sample
is drawn.
N
Refers to random sample drawn from the lot.
n
Refers to the acceptance number.
C
A second sample for inspection is permitted if
the first fails, and two acceptance numbers are
used - the first applying to the observed
numbers of defectives for the 1rst sample alone
and the second applying to the observed
number of defectives for the 1rst and second
samples combined.
Double Sampling
Only a specified sample size is inspected before
a decision is reached regarding the disposition
of the batch, and the acceptance criterion is
expressed as an acceptance number.
Single Sampling
Accepted a bad batch.
Consumers Risk (Beta Error)
Rejected a good batch.
Producer’s risk (Alpha Error)
The acceptance number is specified by AQL.
Square-Root Number System
A risk error designated by alpha error.
Producer’s risk
A risk error designated by beta error
Consumers risk
4 Sources of Quality Variations
Materials
Machines
Methods
Men
Variations within a batch.
Materials
Aging and improper care.
Machines
Negligence by chance.
Methods
Dishonesty, fatigue and carelessness.
Men
Inexact procedure.
Methods
Improper working conditions.
Men
Variations between batches from the same supplier.
Materials
4 Types of Control Functions
Analysis
Monitor
Record, Review and Release
Audit Functions
Tests are made not only on the raw materials and
packaging components but also on the bulk product
during processing and after packaging prior its release to
the market.
Analysis Functions
It is the responsibility of quality control to sample and
examine materials while they are being processed.
Monitor Functions
Environmental Monitoring
Monitor Functions
It is responsible for carefully reviewing the batch record
for that lot and assuring that all necessary records are
present, complete and were feasible to determine if it is
accurate.
Record and Release Functions
The quality audit is designed to detect areas where the
established SOP’s are not being followed andto report
these findings to the supervisor for appropriate action
Audit Functions
A _________ (reception of materials,
incoming cargo report, receiving report or receiving ticket)
should be prepared for every shipment.
Receiving Tally Report (RTR)
As each batch of incoming material is received, it is given a ___________by which it will be identified in subsequent
operations.
Receiving number
Yellow Sticker
Quarantine
Red Stickers
Rejected
Green Sticker
Approved
Raw material container has a
“Hold” sticker.
Quarantine
Return to the supplier or disposed of promptly.
Rejected
Policy that rotated in such a manner that the oldest stock
is used first.
First In, First Out (FIFO)
The QC Analyst uses chemicals to confirm the identity of the sample.
Chemical Identification
Titration was performed to determine the amount of active ingredient present on the
sample.
Purity
Using IR spectroscopy, it can identify the functional groups present in the sample.
Instrumental Identification
Chemical reaction was done to confirm the complete reaction via precipitation, color
change or evolution of gas.
Chemical Identification
HPLC was used to determine the exact composition of the substance.
Instrumental Identification
Organoleptic characteristics are tested with your senses, including visual appearance,
aroma, and flavor.
Physical
Specific gravity of the sample can be determined using Pycnometer.
Physical
Using the flame photometry, it can determine the limit of chemicals (Na, Chlorides,
Sulfates, and Ca) present on the sample.
Limit
Microbiological limits for spoilage organisms or indicators of poor sanitation, including
total plate count, yeast, mold, and coliform.
Limit
Solubility test can determine the dissolution of the compound in a suitable solvent.
Physical
