Study Set Content:
Closing meeting with company:
After the inspection:
Inspection team selected
Before the inspection:
▸Company notified.
Before the inspection
Objective evidence of corrective action
assessed by lead inspector.
After the inspection
If response judged OK, inspection closed out
After the inspection
▸Inspection team reviews documentation on file:
● Site Master File, marketing
authorizations, etc.
● Complaints, recalls, product testing
results, etc.
● Last inspection report.
Before the inspection
▸Lead inspector prepares inspection plan (sent
to company).
Before the inspection:
▸If response not OK, refer to independent
committee.
After the inspection
▸Final Inspection Report prepared & sent to
company after review by an inspection manager
After the inspection
A deficiency that has produced, or may
result in a significant risk of producing, a
product that is harmful to the user
Critical Deficiency
A noncritical deficiency that:
▸has produced or may produce a
product which does not comply with its
marketing authorization; and/or
Major Deficiency
▸indicates a major deviation from the
Code of GMP; and/or
Major Deficiency
indicates a major deviation from the
terms of the manufacturing license or
GMP approval (overseas
manufacturers); and/or
Major Deficiency
A deficiency that cannot be classified as
either critical or major, but indicates a
departure from good manufacturing
practice
Other” Deficiency (or Minor Deficiency
indicates a failure to carry out
satisfactory procedures for release of
batches and/or
Major Deficiency
indicates a failure of the person
responsible for QA/QC to fulfill his/her
duties; and/or
Major Deficiency
A deficiency may be “other” either
because it is judged as minor, or
because there is insufficient information
to classify it as major or critical
”Other” Deficiency (or Minor Deficiency)
▸consists of several other deficiencies,
none of which on its own may be major,
but which may together represent a
major deficiency and should be
explained and reported as such
Major Deficiency
One off minor lapses or less significant
issues are usually not formally reported,
but are brought to the attention of the
manufacturer
”Other” Deficiency (or Minor Deficiency
ISO
International Organization for Standardization
