RGA 6459 Northeaster University Substance Manufacturing Facility Essay

Description

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?

Explanation & Answer:

2 pages

User generated content is uploaded by users for the purposes of learning and should be used following our honor code & terms of service.



^{Have a similar assignment? "Place an order for your assignment and have exceptional work written by our team of experts, guaranteeing you A results."}

Our Service Charter

1. Professional & Expert Writers: Essay Noon only hires the best. Our writers are specially selected and recruited, after which they undergo further training to perfect their skills for specialization purposes. Moreover, our writers are holders of masters and Ph.D. degrees. They have impressive academic records, besides being native English speakers.

2. Top Quality Papers: Our customers are always guaranteed of papers that exceed their expectations. All our writers have +5 years of experience. This implies that all papers are written by individuals who are experts in their fields. In addition, the quality team reviews all the papers before sending them to the customers.

3. Plagiarism-Free Papers: All papers provided by Essay Noon are written from scratch. Appropriate referencing and citation of key information are followed. Plagiarism checkers are used by the Quality assurance team and our editors just to double-check that there are no instances of plagiarism.

4. Timely Delivery: Time wasted is equivalent to a failed dedication and commitment. Essay Noon are known for the timely delivery of any pending customer orders. Customers are well informed of the progress of their papers to ensure they keep track of what the writer is providing before the final draft is sent for grading.

5. Affordable Prices: Our prices are fairly structured to fit in all groups. Any customer willing to place their assignments with us can do so at very affordable prices. In addition, our customers enjoy regular discounts and bonuses.

6. 24/7 Customer Support: At Essay Noon, we have put in place a team of experts who answer all customer inquiries promptly. The best part is the ever-availability of the team. Customers can make inquiries anytime.