I work at a facility where the R&D and Commercial Production groups share manufacturing equipment. Because of this, we do a lot of swab and rinse sampling for clean verifications since we don’t have time to validate the cleaning procedures when a new product arrives and becomes our new worst case API.
Currently, the QC group collects swab and rinse samples after Commercial Production runs, and the R&D Analytical group collects after R&D runs.
My question is… what is the “industry standard” as far as who collects the swab and rinse samples in these cases? There is talk about the Production and R&D Formulation groups collecting samples themselves to eliminate the need for analysts to enter the production area.
Does anyone have any opinions on this? Thanks!
Dear Mr. Wolverine97,
In my opinion (which I hope is in compliance with cGMP requirements), sampling should be performed in an unbiased manner i.e. sampling should be performed by one who is not involved in cleaning or using the equipment (for manufacturing or R&D trials). Hence, the preferable candidates for sampling are IPQC (in-porcess quality control) inspectors (who are generally involved in taking the samples during manufacturing and entering the production area is not an issue for them) or it should be someone from QA/QC. Obviously, the personnel involved (in sampling) are required to be trained and qualified for sampling.
Regards,
Ovais, thanks a lot for taking the time to reply to both of my questions. I appreciate you sharing your expertise :).