Sampling plan is a schedule to draw sample from the prior fix sampling points.
Sampling from bore well (at initial stage)
During project of a pharma facility, bore well location has finalized and from this tentative bore well sampling for one week has done and this bore well water analyzed for complete parameter including chemical and microbiological. These analyses initially can be done by external approved agency.
After getting the result, if all parameter are under limits of raw water and all pathogen are absent then this tentative location of bore well finalized and all analyzed parameter sent to vendor to whom we have to purchase a water system.
In case any pathogen has seen on the bore well water immediately bore well location to be change anywhere and same process to be repeated for this new bore well location.
Bore well finalization depends on absence of all pathogens.
Vendor shall design the water system as per URS (User Requirement Specification) given by pharmaceutical firm.
Sampling point shall fixed after and before of each stage of water system, like first sampling point will be from bore well than after raw water storage tank and than before and after chlorination so on with all user points…. As per design of water system
Sampling During Qualification Stages
After successful installation & operational qualification, performance qualification to be planned in three phases:-
- I- Phase
Sampling plan during I-Phase
During I-Phase of qualification sampling from all sampling point to be done daily and analyze as per prior fixed specification.
Sampling plan during II-Phase
During II-Phase of qualification, all sampling points shall cover sampling from all sampling point to be done and it should be daily and analyze as per prior fixed specification. E.g. If 10 sampling points are in system then they should sample as per the plan so that all sampling point sample within a week.
Sampling plan during III-Phase
During III-Phase of qualification, sampling plan fixed in II-Phase shall go on for one year (period for third phase). During phase-III evaluations, if its need to do more sampling from a particular point as per whether variations, sampling points finalized accordingly and recorded.
Finalization of routine sampling plan
After III-phase sampling plan shall fix to cover all season variations sampling shall be done accordingly in routine.
In routine one sampling point from where water to be used for manufacturing analyzed daily, after getting the results from QC on daily basis, manufacturing shall start.