Dear Ambika,
I feel deviation has to be raised if particular observation noticed
during the processing the batch it will help to address the
corrective and preventive action taken and to evaluate the risk assessment.
I understand that you are following the change control procedure for
replacing any part / equipment, etc...... which is one of the GMP requirement.
Further If any part is been replaced during the preventive
maintenance of the particular equipment / instrument, in that case
change control is suffice and no need to raise the deviation.
Thank you.
Best regards,
Kailash Niranjan
09925109921
The GMP Discussion Group is sponsored by gmp review - see
http://www.pharmweb.net/gmp.html
|