The specifications for the sterilizer and the sterilization process;
- a) IQ / OQ data;
- b) Physical and microbiological records of the entire PQ run;
- c) All pressure gauges and recorders have been calibrated and within the validity period.
- d) Regulations on audit and re verification
- e) Confirmation plan / procedure
- f) Documented procedures used
- g) Documented operating procedures including process control limits
- h) If the fault occurs, the description of the problem, the corrective actions carried out and the impact on the confirmation.
- i) In case of deviation from the scheme, details of the deviation and evaluation of the impact on the confirmation and its results.
The purpose of this activity is to undertake and document a review of the validation data to confirm the acceptability against the approved validation procedures/protocol for the sterilization process and to approve the process specification.
Comments: