Services Categories

Regulatory reference/Validation strategy

Normal temperature warehouse Mapping

ISPE   C & Q Guideline，ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Cool warehouse Mapping

ISPE   C & Q Guideline，ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Constant temperature and humidity room Mapping

ISPE   C & Q Guideline，ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Cold storage Mapping

ISPE   C & Q Guideline，ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Freezer Mapping

ISPE   C & Q Guideline，ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

RF refrigerated container Mapping

ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Refrigerator Mapping

ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Ultra low temperature refrigerator Mapping

ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Liquid nitrogen storage system Mapping

ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP

Transportation verification (including drop test) validation

ISPE，CTC mapping；USP   659；WHO TRS 961 Supplement 8；China   GSP；GMP VERIFICATION AND VALIDATION APPENDIX