Product Quality Lifecycle Implementation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Product Quality Lifecycle Implementation
The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 120-127

The International Society for Pharmaceutical Engineering (ISPE) has released the first two parts of the ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement. These guides provide a practical approach to implementation of International Conference on Harmonization (ICH) guidelines on pharmaceutical development, quality risk management, and the pharmaceutical quality system, as well as FDA guidance produced under the Pharmaceutical CGMPs for the 21st Century Initiative, including guidance on process analytical technology (PAT) and quality systems (1–6). More recently, FDA published guidance on process validation (7); the ISPE series also provides information and assistance to meet Stage 1 (Process Design) of this guidance.

The ISPE Guide series is intended to assist and be a reference for practitioners involved in development, implementation, and application in manufacturing, including those involved in continual improvement. The suggestions, information, and examples presented in Parts 1 and 2 of the series have been derived from input from a wide range of companies and individuals who have hands-on experience of successfully applying enhanced, quality-by-design (QbD) approaches.

Background

Part 1 of the ISPE Guide, Product Realization using QbD: Concepts and Principles, provides an overview of the series and a summary of enhanced, QbD approaches to development, including an introduction into manufacture and continual improvement of products and processes. It also provides a practical discussion and examples of of criticality, design space, and control strategy, which are addressed in ICH Q8 (R2) (1).

Part 2, Product Realization using QbD: Illustrative Example, offers a case study of the application of enhanced, QbD approaches to product realization. Part 2 addresses the development and introduction into manufacturing of a small-molecule formulation and associated manufacturing process, as well as part of the drug-substance synthetic route using enhanced, QbD approaches. Compared with other case studies in the public domain, more detail is given about the application of systematic, iterative, and different approaches to product and process understanding using quality risk management.

Parts 1 and 2 provide a range of how-to tools for practitioners developing products and their manufacturing processes using the enhanced, QbD approach described in ICH Q8 (R2). These guides provide more insight than is given in the ICH guidelines, and include more explanation and examples of individual topics, such as criticality as applied, for example, to critical quality attributes and critical process parameters (CQAs and CPPs), design space, and control strategy.

The concepts in the ISPE Guide series apply to both new drug products and existing marketed products. The authors believe that the principles also apply to drug-substance (small and large molecule) process development and continual improvement.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here