Quality by Design: Working with your Contract Manufacturer

摘要

An effective Quality by Design program executed with a Contract Organization is based on open communication to ensure complete knowledge transfer and risk assessment. Evaluating and addressing gaps early in the product lifecycle can ensure robust processes are developed leading to successful commercialization of a dosage form meeting quality target product profile requirements. Sponsor concerns over cost, timeline, and sharing of proprietary information can sometimes derail the Quality by Design process, leading to delays and unnecessary repetition of experimentation late in the development process. Current regulatory environment not only encourages but mandates complete information sharing between contractor and sponsor to facilitate the development and commercialization of quality products using sound QbD principles.