Is it necessary to undergo cleaning validation or swab rinse sampling everytime we manufacture batch after type B cleaning with water.Although our cleaNing system is fully validated.Cleaning validation can only be done by swab and rinse sampling ordo we any other ways better than this.
after every product chang over cleaning may be veryfied by inhouse SCP eg water sample using following test
ph
conductivity
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Yeah sir,. Already you have validated procedure.
Then to make sure to avoid cross- contamination /product mixing ,
Swabs & rince samples is the best way.this provide you high quality assurance.
Dear All,
Is it will be considered as different API (Diclofenac injection grade) and just Diclofenac potassium …while assessment of worst case product…in cleaning validation?
Thanks
Ph of water is checked only once in the morning before usage.but conductivity is checked each time at the time of product changeover.
After washing of a equipment ph of rinse it sample is checked in every product change over.
Ok.thanks
Dear sir, swab is necessary if the API is changing at granulation but with same molecule (Eg: Aspirin and Atorva in single capsule)??
cleaning validation is not necessary for every batch change over type B cleaning is more enough, for once identify the worst case product from all your manufacturing products and label it as worst case, and whenever a new product is introduced compare it with the worst case product and if the new product is most worse than the existing product then cleaning validation is compulsory for the new product or else no need of any cleaning validation.
According to EU (&PIC/S) Annex 15:
Frequent “verification” of cleaning process is also required only in case of “manual” Cleaning
http://www.gmp-compliance.org/guidemgr/files/2015-10_ANNEX15.PDF
So in this case a non specific analytical method is usually used for this purpose for its feasibility in such a routine verification process e.g pH , Conductivity or TOC
This is also based on Annex 15 which “generally” mentioned that such non specific analytical methods may be used if specific methods are “not feasible”
This general concept was also mentioned by WHO
