Dear all…
can u plz provide validation material,bcz iam new to this area
Process Validation is a means of ensuring that
manufacturing processes are capable of consistently
producing a finished product of the required quality. It
involves providing documentary evidence that key steps in
the manufacturing process are consistent and reproducible.
A validated manufacturing process is one that has been
proven to do what it purports or is presented to do.
The term `validation’ is intended to apply to final verification
at the production scale. Typically a minimum of three
consecutive production batches should be successfully
validated prior to the marketing of the product.
a) A short description of the manufacturing process in a
schematic drawing or flow chart
b) A summary of the critical processes, control variables
and justification for their selection
c) Finished product specification (release)
d) Details analytical methods (reference to the dossier)
e) In process controls proposed with acceptance criteria
f) Additional testing intended to be carried out (eg. With
proposed acceptance criteria and analytical validation
appropriate)
g) Sampling plan – where, when and how samples are
taken
h) Details of methods for recording and evaluation of
results
i) Proposed time frames for carrying out the studies