Each person engaged in
the manufacture, processing, packing, or holding of a drug product shall have
education, training, and experience, or any combination thereof, to enable that
person to perform the assigned functions.
Training shall be in
the particular operations that the employee performs and in current good
manufacturing practice (including the current good manufacturing practice
regulations in this chapter and written procedures required by these
regulations) as they relate to the employee's functions.
Training in current
good manufacturing practice shall be conducted by qualified individuals on a
continuing basis and with sufficient frequency to assure that employees remain
familiar with cGMP requirements applicable to them.
Each person responsible
for supervising the manufacture, processing, packing, or holding of a drug
product shall have the education, training, and experience, or any combination
thereof, to perform assigned functions in such a manner as to provide assurance
that the drug product has the safety, identity, strength, quality, and purity
that it purports or is represented to possess.
There shall be an
adequate number of qualified personnel to perform and supervise the
manufacture, processing, packing, or holding of each drug product.
Read following Book:
Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the Pharmaceutical Sciences) Available in Amazon
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