j. Identification of critical control points: There are target points during the life
cycle of product, process and method which may cause hazards. If these points
are identified and controlled, then hazard can be prevented. These are known
as critical control points. Identification of CCP comes under hazard analysis
k. Information on trial production batches, qualification batches and process
l. Experiment design and acceptance criteria for analytical method.
m. Change control for any process deviations encountered.
o. Arrangement for keeping retention samples of active ingredients,
intermediates and finished products and information on reference substances.
p. Conclusion including the sign of designated authority when and wherever
1. SU should provide necessary validation documentation for the process and
2. SU should provide information regarding hazards and critical steps related
to product, method or process concerned. It mainly acts as the basis of
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