Product Quality Lifecycle Implementation - Pharmaceutical Technology

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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

Benefits of an enhanced, QbD approach

Using the enhanced, QbD approach as discussed and exemplified in the PQLI Guides, Parts 1 and 2 has been shown in the development of new products to produce benefits of:

  • enhanced process understanding
  • higher process capability
  • better assurance of product quality
  • increased flexibility to implement continual improvement (12).

Although investment in QbD typically occurs in development and the benefits are reaped in manufacturing, there is considerable value to the business. Some examples are discussed below.

A product developed using QbD principles was showing 0.7% deviation rates in the first year of launch compared with two other products launched about 15 years earlier using the traditional approach with some continual improvement, which had deviation rates in a range up to 8% (12). As a further example, a product developed using QbD principles showed CQA of Assay PpK at launch of 1.2 (3–4σ) which rose to a PpK of 1.8 (5–6σ) six months postlaunch. Due to a well-developed design space, a site was able to increase productivity by 66% by optimizing process parameters within a design space and without regulatory filing when demand was four times its forecast.

In another example, development of a product leading to real time release testing gave a pay back of about one year with reduced throughput time and associated reduced inventory costs, and with a reduction in laboratory quality control costs.

Significant business benefits also have been reported in applying the enhanced, QbD approach to continual improvement of existing products (13). These benefits include increased yield, reduced variability, and decreased throughput time leading to decreased inventory levels, increased assurance of success of batch release. There also was some flexibility in regulatory commitments in terms of reduced stability studies and a different approach to process validation. Other benefits are suggested in the ISPE Guides.

It is considered that the guides can be of assistance in developing products and processes in line with Stage 1 (Process Design) of the FDA process validation guidance allowing rational selection of attributes and parameters and associated acceptance criteria for inclusion in Stage 2 (Process Performance Qualification) of the guidance (7).

Although proposing a design space is optional, extremely convincing justifications with examples are given in Part 1 for the benefits of developing and proposing a design space.


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