Dear Jennifer:
Thank you. I will take note on the applicable points during the preparation of the above documents. Actually, I also plan to incorporate the managing of regulatory contact / inspection and sampling into the company’s Personal Hygiene procedure under the same section of ‘Visitors’. I will also include:
a) the specific personnel to accompany the regulatory inspection/sampling.
b) taking duplicate or triplicate samples for retention and also for external lab test, if necessary.
c) place the particular batch or lot on-hold until we get the satisfactory result.
d) follow product recall procedure if deemed necessary
e) specify the personnel to keep all the related records.
f) etc.
Regards,
Yong