As an API supplier, if you set a retest period instead of a shelf life,
the COA has a retest date:
1. Do you have to test the material ON that date, or just prior to
use, past that date?
2. If you retest 'prior to use' what is the time frame for using
the material? 14 days, 30 days, ...?
3. Is it the responsibility of the purchaser to retest their
material at/after the retest date. Or does the API supplier have to
test it and send out new COAs to all the purchasers?
4. If you set a retest date, once you reach that date, do you
retest prior to each use. Or do you set a new retest date based on the
5. If you set a retest date, do you also set an expiry date?
6. If the material is a sterile product, does this change any of
the above? Since you need to verify continued sterility at the end of
shelf life (or retest period).
ICH Q1A explains the differences in the definitions, but doesn't address
practical implications/logistics of being a supplier to outside
CONFIDENTIALITY STATEMENT: The information contained in this message may be privileged and confidential. It is intended only for the use of the individual named above. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this message is prohibited. If you have received this message in error, please advise the sender by reply e-mail, and delete this message and any attachments.
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services