global health writing question and need the explanation and answer to help me learn.
Assignment:
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).
Background Information:
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.
Prompt:
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
We are a professional custom writing website. If you have searched a question and bumped into our website just know you are in the right place to get help in your coursework.
Yes. We have posted over our previous orders to display our experience. Since we have done this question before, we can also do it for you. To make sure we do it perfectly, please fill our Order Form. Filling the order form correctly will assist our team in referencing, specifications and future communication.
1. Click on the “Place order tab at the top menu or “Order Now” icon at the bottom and a new page will appear with an order form to be filled.
2. Fill in your paper’s requirements in the "PAPER INFORMATION" section and click “PRICE CALCULATION” at the bottom to calculate your order price.
3. Fill in your paper’s academic level, deadline and the required number of pages from the drop-down menus.
4. Click “FINAL STEP” to enter your registration details and get an account with us for record keeping and then, click on “PROCEED TO CHECKOUT” at the bottom of the page.
5. From there, the payment sections will show, follow the guided payment process and your order will be available for our writing team to work on it.
Need this assignment or any other paper?
Click here and claim 25% off
Discount code SAVE25