global health writing question and need the explanation and answer to help me learn.
In a 1-2 page essay, evaluate strategies for registering a new drug substance (DS) manufacturing facility and implementing DS made from that site in all drug product (DP).
Throughout development Sponsors may utilize several different DS/DP manufacturing facilities to generate multiple batches that may serve a variety of different purposes (e.g. clinical trial material, nonclinical toxicology material). Sponsors may also elect to register new facilities for DS/DP manufacture that were not previously listed in the IND or marketing application.
Sponsors must validate the effects of post approval manufacturing changes on identity, strength, purity, and potency as they may relate to product safety or effectiveness before distributing product made with the change. They must notify FDA of changes to conditions established in an approved application-
including manufacturing site changes- in accordance with 21 CFR 314.70 and 601.12.
Getafix Pharmaceuticals manufactures Saros (sarasotastat) DS at Sites A and B and Saros DP at Sites X, Y, and Z. DS from Site A and Site B have previously been shown to be comparable, while DP from Sites X, Y, and Z have been shown to be comparable. DP sites manufacture product using DS made from Site A and Site B. Getafix Pharmaceuticals would like to transfer DS manufacturing from Site A to
Site C, and implement Site C DS in all DP sites.
Based on your understanding and relevant FDA Guidances (e.g. Comparability Protocols for Human Drugs and Biologics: CMC) and ICH Guidelines (ICH Q1A), address the following questions pertaining to the information provided above:
1) What is needed to implement DS in DP? Choose yes or no for the strategies below, and explain why:
a. Commitment to put first DP batch produced with Site C DS on stability at each DP site?
b. Put 1-3 batches at first DP site on stability and file with 6-12 months data?
c. Perform a side-by-side stress comparability study?
2) Once Site C is implemented in a specific DP site, what should be the ongoing stability commitment
for DP? Choose yes or no for the following strategies, and explain why:
a. Commitment to put every combination of DS/DP on stability? (e.g. Site X DP with Site A
DS, Site X DP with Site B DS, Site X DP with Site C DS)
b. Commitment to put one representative DP lot on stability (using any comparable DS)?
c. Commitment to put one representative DP lot on stability using DS registered and approved?
Requirements: 2 pages
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