scholarly journals An industrial case study: QbD to accelerate time-to-market of a drug product

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Madalena Testas ◽  
Tiago da Cunha Sais ◽  
Leonardo Piccoli Medinilha ◽  
Katia Nami Ito Niwa ◽  
Lucas Sponton de Carvalho ◽  
...  
Keyword(s):  
Process Development ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Product Knowledge ◽  
Industrial Case Study ◽  
Actual Application ◽  
Product And Process Knowledge ◽  
Product And Process ◽  
Regulatory Flexibility

AbstractThe use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.

Quality by design case study: An integrated multivariate approach to drug product and process development

2009 ◽  
Vol 382 (1-2) ◽  
pp. 23-32 ◽  
Author(s):  
Jun Huang ◽  
Goldi Kaul ◽  
Chunsheng Cai ◽  
Ramarao Chatlapalli ◽  
Pedro Hernandez-Abad ◽  
...  
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Drug Product ◽  
Multivariate Approach ◽  
Design Case ◽  
Product And Process ◽  
Design Case Study

A pragmatic approach to interactive assembly sequence evaluation

2003 ◽  
Vol 217 (4) ◽  
pp. 541-550 ◽  
Author(s):  
C J Barnes ◽  
G E M Jared ◽  
K G Swift
Keyword(s):  
Relevant Literature ◽  
Stability Index ◽  
Design System ◽  
Assembly Planning ◽  
Assembly Sequence ◽  
Industrial Case Study ◽  
Assembly Sequences ◽  
Product And Process ◽  
Difficulty Index

An assembly-oriented design system has been developed which includes several analysis tools to improve product assemblability during product development. One of these tools supports the parallel development of the product design and the assembly sequence, thus exploiting the benefits of concurrent consideration of product and process. However, this approach requires some method for evaluating the sequence against requirements. Previous work on assembly sequence evaluation has concentrated on identifying the best from a set of ranked alternatives. When a single sequence is constructed, as with this tool, another method is needed. This paper reports the development of this novel methodology for evaluating individual assembly sequences. A review of the relevant literature has found several measures for identifying good assembly sequences from a ranked list and the fundamental sequence attributes extrapolated and aggregated. This leads to the proposal of four new indices: insertion index, stability index, difficulty index and complexity index. A large number of assembly sequences have been analysed to define limiting values for the indices such that they can quantify the potential of an incomplete sequence resulting in a satisfactory solution. The application of these indices in concurrent design and assembly planning is illustrated through an industrial case study.

Towards Holistic Traceability Solution

2014 ◽  
Vol 5 (1) ◽  
pp. 24-38 ◽  
Author(s):  
Usman Durrani ◽  
Zijad Pita ◽  
Joan Richardson ◽  
John Lenarcic
Keyword(s):  
Product Knowledge ◽  
Software Development Process ◽  
Holistic Model ◽  
Process Knowledge ◽  
Meta Model ◽  
Practical Guidelines ◽  
Product And Process Knowledge ◽  
Product And Process ◽  
Definition Of ◽  
Leading Journals

The purpose of traceability is to ensure persistent alignment of product knowledge between stakeholders, artifacts, and traceability objects. On the other hand, process knowledge is equally important to ensure a systematic software development process with accurate specification and verifiable quality attributes. Previous studies lacks in presenting a consolidated view from product and process knowledge perspectives. This study has taken a systematic literature review approach to evaluate sixty one previously published papers on traceability in leading journals and conferences. Based on the findings, the authors propose to extend the definition of an existing traceability meta-model to combine both product and process knowledge perspectives. The scope of this paper is to define the extension of the traceability meta-model without violating any of its statements. This study aims to contribute by taking steps towards defining a holistic model of traceability that will provide practical guidelines to IT practitioners in general and to process engineers in particular.

scholarly journals Externalizing tacit overview knowledge: A model-based approach to supporting design teams

2007 ◽  
Vol 21 (3) ◽  
pp. 227-242 ◽  
Author(s):  
Tomás Flanagan ◽  
Claudia Eckert ◽  
P. John Clarkson
Keyword(s):  
Diesel Engine ◽  
Large Scale ◽  
Process Models ◽  
Development Programs ◽  
Industrial Case Study ◽  
Additional Information ◽  
Engine Design ◽  
Team Interactions ◽  
Product And Process

AbstractSuccessful realization of large-scale product development programs is challenging because of complex product and process dependencies and complicated team interactions. Proficient teamwork is underpinned by knowledge of the manner in which tasks performed by different design participants fit together to create an effective whole. Based on an extensive industrial case study with a diesel engine company, this paper first argues that the overview and experience of senior designers play an important part in supporting teamwork by coordinating activities and facilitating proactive communication across large project teams. As experts move on and novices or contractors are hired, problems are likely to occur as tacit overview knowledge is lost. If informal, overview-driven processes break down, the risk of costly oversights will increase, and greater management overhead will be required to realize successful product designs. Existing process models provide a means to express the connectivity between tasks and components thus to compensate partially for the loss of tacit overview. This paper proposes the use of design confidence, a metric that reflects the designer's belief in the maturity of a particular design parameter at a given point in the process, to address the limitations of existing models. The applicability of confidence-based design models in providing overview, as well as their shortcomings, will be demonstrated through the example of a diesel engine design process. Confidence can be used to make overview knowledge explicit and convey additional information about the design artifact, thereby informing communication and negotiation between teams.

An Industrial Case Study: Identification of Competencies of Design Engineers

2007 ◽  
Vol 129 (7) ◽  
pp. 709-716 ◽  
Author(s):  
Saeema Ahmed
Keyword(s):  
Empirical Study ◽  
Product Knowledge ◽  
Industrial Case Study ◽  
Process Knowledge ◽  
Complex Products ◽  
Large Company ◽  
Types Of Knowledge ◽  
Design Engineers ◽  
And Training

This paper describes the findings from an empirical study carried out with engineers in senior roles within a large company manufacturing complex products. This research aimed to identify the types of knowledge that are important for design engineers. Twenty four knowledge categories were identified and the importance of these for design engineers in industry was investigated. In addition, the number of years of relevant experience required to become an expert in these types of knowledge was investigated. Knowledge related to the process was perceived as more important to those related to the product. However, the number of years to become an expert in process knowledge was found to be lower than for product knowledge, despite process knowledge being perceived as more important. The findings of this research contribute to the education and training of design engineers.

Integrated Product and Process Modelling

2003 ◽  
Author(s):  
Patrik Nilsson ◽  
Bjo¨rn Fagerstro¨m
Keyword(s):  
Process Modeling ◽  
Concurrent Engineering ◽  
Product Modeling ◽  
Commercial Software ◽  
Industrial Case Study ◽  
Related Information ◽  
Proposed Model ◽  
Product And Process ◽  
Important Basis

This paper presents a model for integrated product and process modeling. The aim is to investigate how product and process related information could be structured and managed in order to bridge the gap between the product and the process. Integrated product and process modeling is an important basis for concurrent engineering, as it provides a shared representation of the evolving design. First, an introduction to product modeling is discussed. Then, the proposed model, theoretically based on chromosome model, is presented. Second, process modeling is discussed, and more common tools/methods for process modeling are presented. Third, and finally, an industrial case study is presented, where the proposed model has been applied and evaluated in commercial software.

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