In past we installed an air shower in Oncology area. But at that time we do not performed its qualification (i.e. DQ, IQ, OQ, PQ). we have received an observation in a customer audit recently. So, we did the qualification for the response of this audit but we did not prepared the SOP for Air shower. so, can we prepare the SOP after completion of air shower qualification? If yes, which reference I can take for that (i.e. for change control) and what justification we addressed in change control?
Air shower help for the decontamination problems in criticale molecule manufacturing area.
Justification: For system improvision/System up Gradation with respect of any contamination, However , Over the period of time, We were not identify any quality related issue over routine commercial product)s) with respect of any contamination issue.
Existing System :We are following entry proedure in oncology area through simple instruction of air shower.
Proposed System: We are following entry & usage proedure in oncology area through Standard operation procedure after cGMP procedure i.e. qulaification,Training & its implimenation.
Yes, You might took a Change control with referance of minor categary against the audit observation. Separate task to be generated for following activity.
1.Risk assesment evaluated against this proposal i.e. any hampering routine activity and or quality related to IH products.
2. DQ/IQ/OQ/PQ protocol & report execuation.
3. Drafiting of New SOP.
4.Train the all users.
Its personal opinion, however IH Quality personl must agree upon any changes.
Thank you sir for guiding me