Stability_Extension_Questions_and_Answers.pdf

Stability Extension Questions Page 1

1. TEST METHODS

Questions regarding the HPLC test method cited in the SOW are as follows:

Can USG provide a copy of the test method prior to proposal submission? No. The offeror is expected to have the test methods already prepared and validated, and have trained personnel to perform them.

Can USG provide key details of the test method (detection mode, separation mode, run time, column manufacturer and type)? The offeror is expected to know and understand how the test methods work and are performed, and how to interpret the results.

Will USG provide peramivir reference standard material over the life of the contract?

Peramivir reference can be made available.

Will USG qualify peramivir reference standard material (e.g. by annual re-testing) over the life of the contract? No. The offeror is expected to manage all stability hold material needed to fulfill the SOW and test on a yearly basis.

Is a validated dye ingress test method a suitable alternative to sterility testing for the stability studies? The offeror will be expected to explain how they intend to perform this method and why it would be the method of choice for sterility testing.

2. STABILITY STUDY

Questions regarding the stability testing requirements outlined in the SOW are as follows:

Table 1 in the SOW shows multiple lots for the 60- and 84-mo timepoints. Were the multiple lots set up coincidentally (at the same time) or were the initial timepoints staggered for the individual lots? The lots were staggered.

Table 1 indicates containers in the inverted orientation. Is inverted the only orientation required (i.e. no requirement for studying vials in the upright orientation)?

Correct

3. LEACHABLES AND EXTRACTABLES

Questions regarding the leachables/extractables studies are as follows:

Stability Extension Questions Page 2

Does USG really require “extractables” testing on stability (normally stability monitoring concerns the actual leachable impurities)? Yes.

Would USG consider a quote for leachables/extractables studies independent of the stability testing? The quote should cover all testing described in the SOW. If extractible/leachable testing cannot be done on site, the offeror is allowed to subcontract that portion of the work, and provide a cost estimate.

What is the composition of the vehicle used to formulate drug product? The vehicle is aqueous with some additives to control pH and salinity conc.

Are suitable control samples (vehicle exposed to closure materials and drug product never exposed to closure materials) available? Control samples can be made available to the offeror, if necessary.

Would USG consider as an alternative to extensive leachables/extractables studies, stability monitoring with a suitable HPLC method using one or more “universal” detection techniques? No. The offeror will have to adhere to the testing described in the SOW, since it will be used to extend testing data already performed.