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Chapter 6 Quality Control (General (QC personnel (access to production…
Chapter 6 Quality Control
General
QC concern
sampling, specifications, testing, organisation, documentation & release procedures
ensure necessary tests to carry out
materials not released for use, nor products released for sale & supply
until quality assessed to satisfactory
QC Department
have a laboratory
adequately staffed & fully equipped
perform QC tests, required before, during & after manufacture
absence of in-house laboratory
services of external laboratory can be used
to conduct quality control tests
quality of final product
remains responsibility/liability of manufacturer
finished products assessment
embrace all relevant factors
production condition, results of in-process testing, a review of manufacturing (include packaging) documentation
compliance with Finished Product Specification
examination of final finished pack
QC personnel
access to production areas
for sampling & investigation
have particular expertise
able to carry out identification tests
recognise adulteration, the presence of fungal growth, infestations, & non-uniformity within delivery of crude plant
identity & quality test
starting materials
finished products
duties of QC Department
to establish & implement all QC procedures
keep reference samples of materials & products
ensure correct labelling of containers of materials & products
ensure the monitoring of stability of products
operations carry out in accordance with written procedures & recorded
stability be monitored
bulk, intermediate & finished product
continuous appropriate programme
permit detection of any stability issue
associated with formulation in marketed package
Sampling
crude drugs
aggregate of individual natural materials
contain an element of heterogeneity
sampling carry out with special care
by personnel with particular expertise
each batch identified by own documentation
describe written procedures
method of sampling
equipment to be used
amount of sample to be taken
instructions for any required subdivision of sample
type & condition of the sample container to be used
identification of containers sampled
storage conditions
instructions for cleaning & storage of sampling equipment
reference sample
materials @ products
representative of batch of they taken
finished products
retained till one year after expiry date
kept in their final packaging
stored under recommended conditions
other samples
taken to monitor most stressed part of a process
(e.g. beginning or end of a process
sample containers
label indicate contents
with the batch number
with date of sampling & containers from which samples have been drawn
Testing
testing operations
described in Product Registration dossier
carry out according to approved methods
results obtained
be recorded & checked
make sure consistent with each other
any calculations critically examined
record data
name of the material @ product and, where applicable, dosage form
batch number, where appropriate, manufacturers @ supplier
references to relevant specifications & testing procedures
test results, include observations & calculations, reference to any certificates of analysis
dates of testing
initials of persons who performed testing
initials of persons who verified testing & calculations, where appropriate
a clear statement of release @ rejection @ other status decision & dated signature of designated responsible person
in-process controls
made in production area by production personnel
performed according to methods approved by QC
results recorded