PQLI Control Strategy Model and Concepts

Davis, Bruce C.; Lundsberg, Line; Cook, Graham

doi:10.1007/s12247-008-9035-1

Cited by 29 publications

(12 citation statements)

References 2 publications

(2 reference statements)

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“…Lately, it has been pointed out that the use of such practices has not been formally applied in the pharmaceutical industry. Working towards an ideal maximum level of quality assurance and performance in the pharmaceutical industry, the design space is directly linked to a welldefined control strategy [3] and criticality assessment [4]. A process variable, material property, process, or step is defined as critical if it causes significant variability in the product quality or process performance within a range of values of the variable that is likely to occur if the variable is not properly controlled.…”

Section: Definition Of Design Space In Pharmaceutical Engineeringmentioning

confidence: 99%

Design Space of Pharmaceutical Processes Using Data-Driven-Based Methods

2010

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Introduction The identification and graphical representation of process design space are critical in locating not only feasible but also optimum operating variable ranges and design configurations. In this work, the mapping of the design space of pharmaceutical processes is achieved using the ideas of process operability and flexibility under uncertainty. Methods For this purpose, three approaches are proposed which are based on different data-driven modeling techniques: response surface methodology, high-dimensional model representation, and kriging methodology. Using these approaches, models that describe the behavior of the process at different design configurations are generated using solely experimental data. The models are utilized in mixed integer non-linear programming formulations, where the optimum designs are identified for different combinations of input parameters within the operating parameter and material property ranges. Results Based on this idea, by defining a desirable output range, the corresponding range of input variables that result to acceptable performance can be accurately calculated and graphically represented. Conclusions The main advantages of the methodologies used in this work are, firstly, that there is no restriction by the lack of first-principle models that describe the investigated process and, secondly, that the models developed are computationally inexpensive. This work can also be used for the comparative analysis of the use of different surrogate-based methodologies for the identification of pharmaceutical process Design Space.

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Section: Definition Of Design Space In Pharmaceutical Engineeringmentioning

confidence: 99%

Design Space of Pharmaceutical Processes Using Data-Driven-Based Methods

2010

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“…Companies Develop and Implement throughout the ProductLifecycle, a Well-Defined Acceptance Sampling System Based on the Principles of Existing Consensus Standards to Serve as Part of the DDU Control Strategy A product control strategy is a "comprehensive plan for ensuring that the final product meets critical requirements and therefore, the needs of the patient" (22). As described in ICH Q8(R2) (23), control strategy approaches can range from minimalistic approaches that rely heavily on intermediate and end-product testing to more enhanced QbD approaches where the "quality controls are shifted upstream" with real-time release and "reduced end-product testing" possible.…”

Section: An Alternative Default Standard Dqlmentioning

confidence: 99%

Challenges and Opportunities in Implementing the FDA Default Parametric Tolerance Interval Two One-Sided Test for Delivered Dose Uniformity of Orally Inhaled Products

Larner

Cooper

Lyapustina³

et al. 2011

AAPS PharmSciTech

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Abstract. The goal of this article is to discuss considerations regarding implementation of the parametric tolerance interval two one-sided test (PTI-TOST) for delivered dose uniformity (DDU) of orally inhaled products (OIPs). That test was proposed by FDA in 2005 as an alternative to the counting test described in the 1998 draft FDA guidance for metered dose inhalers and dry powder inhalers. The 2005 PTI-TOST, however, still has not found much use in practice despite the general desirability of parametric approaches in modern pharmaceutical quality control. A key reason for its slow uptake is that it rejects, with high probability, batches whose quality is considered acceptable by all other published regulatory and pharmacopeial standards as well as by the DDU specifications for many approved OIPs. Manufacturers therefore continue using nonparametric counting tests for control of DDU. A simulated case study presented here compares the consequences of the PTI-TOST compared to the counting test. The article discusses three possibilities that would help increase the uptake of the PTI-TOST approach, namely: product-specific quality standards, a different default standard suitable for the majority of OIPs, and integration of the PTI-TOST with a continuous verification control strategy rather than using it as an isolated-batch (transactional) end-product testing. In any of these efforts, if a parametric test is used, it is critical not to set the target quality close to, or at the boundary of the process/product capabilities, because PTI tests are designed to reject with high probability the identified target quality.

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“…Level 2 considers the critical process parameters, material attributes and compo- This Control Strategy Model is described in more detail in the paper PQLI Control Strategy Model and Concepts [20] in this Volume of the Journal of Pharmaceutical Innovation.…”

Section: Control Strategymentioning

confidence: 99%

PQLI Key Topics - Criticality, Design Space, and Control Strategy

2008

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This paper gives an overview of progress made by the ISPE PQLI initiative -a global industry-led initiative aimed at facilitating the implementation of ICH Q8, Q9, and ultimately Q10 guidance. Through this initiative ISPE is spearheading the effort to help industry begin to define areas where they will be able to provide the technical framework for the implementation of key elements of Quality by Design (QbD) -a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management. Three topic areas, Design Space, Criticality, and Control Strategy were selected for specific focus and discussion, and this paper gives an overview of progress in these three areas.

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PQLI Control Strategy Model and Concepts

Cited by 29 publications

References 2 publications

Design Space of Pharmaceutical Processes Using Data-Driven-Based Methods

Design Space of Pharmaceutical Processes Using Data-Driven-Based Methods

Challenges and Opportunities in Implementing the FDA Default Parametric Tolerance Interval Two One-Sided Test for Delivered Dose Uniformity of Orally Inhaled Products

PQLI Key Topics - Criticality, Design Space, and Control Strategy

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