1.
Define complaint & recall.
All quality related complaints of a product from the
market should be recorded & investigated accordingly to a written
procedure.
Recall is the removal from the market of specified batches or all
batches of a product. A recall situation can result from information entering a
company in various ways:
•
Customer complaints – these
may be so serious as to initiate a
recall. An example could be the evidence of a lack of
sterility
•
GMP deviations/results of a
failure investigation
•
The result from the QC
stability programme
•
Request by the regulatory
authorities
•
Result of an inspection
•
Known counterfeiting or
tampering
•
Adverse drug reaction (ADR)
reported, leading to a recall decision (however, an ADR does not automatically
lead to a recall).
2.
Define Corrective Action & Preventive Action ?
Preventive
Action : In order to prevent
occurrence the potential action has to be taken from non conformity, defect or other undesirable
situation.
Corrective
Action : Action has to be taken to eliminate the detected non conformity
or other undesirable situation.
3.
What is In Process Control ? Why it is important ?
To ensure the product conformation of its
specification, checking & monitoring are performed during production. The
controlled of the environment or equipment may also be regarded as part of in
process controlled.
Importance : It is important to adjust the process to
assure that the product confirms to it final specification.
4.
What is Sanitation & House keeping?
Sanitation : It is the hygienic control on manufacturing process
including personnel, premises, equipment & material handling.
Housekeeping is the
practice of keeping the workplace clean, tidy & free of potential hazards. Correct housekeeping is practised before, during &
after the task is completed.
5.
What is self inspection?
Self inspections should
be conducted in order to monitor the implementation and compliance with Good
Manufacturing Practice principles and to propose necessary corrective measures.
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