Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.


Pharmaceutical Technology
Volume 37, Issue 5, pp. 64-68

Finally, the identification of CQAs and understanding the influence certain material attributes exude on the manufacturing process should be considered a crucial aspect of the process. This is the area where implementing a control strategy and employing QRM becomes essential; and the concept of design space is introduced into the manufacturing equation. According to Q11, design space is the multidimensional combination and interaction of two elements: input variables and process parameters (1). Design space (as defined by the manufacturer) is subject to regulatory oversight by FDA. ICH Q8 (2.4) provides additional detail on the topic of design space.

The submission process for the enhanced approach: document requirements. There are mandatory submission requirements in support of manufacturing process development that must be considered by drug-substance manufacturers. The submission must contain sufficient detail to support the claim for product safety and efficacy needed for eventual commercialization. For example, the expectation is that the following documentation be included as part of the drug-substance submission.

  • An overall summary of the development process including: CQAs; description of design stages; description of material attributes; description of process parameters; and description and development of design spaces should be provided.
  • CQAs of the drug substance shall be listed.
  • A detailed discussion of the manufacturing process history needs to be provided.
  • Manufacturing development studies, including risk assessments employed in support of commercial development, including the control strategy, must be provided.

Description of process and process controls employed in manufacturing. It is imperative that the manufacturers of drug substances provide a detailed description of the manufacturing process and the processing controls employed. The most efficient way to adequate delineate processes is through the creation of flow charts. Flow charts are an inherent requirement, regardless of submission type. In fact, Q11 requires that a flow chart be provided as part of the submission process.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here