Process Design: Stage 1 of the FDA Process Validation Guidance

2017 ◽  
pp. 115-154
Author(s):  
Richard K. Burdick ◽  
David J. LeBlond ◽  
Lori B. Pfahler ◽  
Jorge Quiroz ◽  
Leslie Sidor ◽  
...  
Keyword(s):  
Process Design ◽  
Design Stage ◽  
Process Validation ◽  
Stage 1

scholarly journals Process Validation and Critical Regulatory Requirements in Manufacturing of Inactivated Veterinary Vaccines

2018 ◽  
Vol 3 (2) ◽  
Keyword(s):  
Process Design ◽  
Scientific Evidence ◽  
Good Manufacturing Practice ◽  
Critical Parameters ◽  
Design Stage ◽  
Vaccine Production ◽  
Regulatory Requirement ◽  
Process Validation ◽  
Veterinary Vaccine ◽  
Process Qualification

Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.

scholarly journals ‘I’m fine!’: Assertions of lack of support need among patients with chronic obstructive pulmonary disease: A mixed-methods study

2021 ◽  
pp. 174239532110003
Author(s):  
A Carole Gardener ◽  
Caroline Moore ◽  
Morag Farquhar ◽  
Gail Ewing ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Mixed Method ◽  
Self Report ◽  
Design Stage ◽  
Chronic Obstructive ◽  
Support Needs ◽  
Obstructive Pulmonary Disease ◽  
Stage 1 ◽  
The Impact

Objectives To understand how people with Chronic Obstructive Pulmonary Disease (COPD) disavow their support needs and the impact on care. Methods Two stage mixed-method design. Stage 1 involved sub-analyses of data from a mixed-method population-based longitudinal study exploring the needs of patients with advanced COPD. Using adapted criteria from mental health research, we identified 21 patients who disavowed their needs from the 235 patient cohort. Qualitative interview transcripts and self-report measures were analysed to compare these patients with the remaining cohort. In stage 2 focus groups (n = 2) with primary healthcare practitioners (n = 9) explored the implications of Stage 1 findings. Results Patients who disavowed their support needs described non-compliance with symptom management and avoidance of future care planning (qualitative data). Analysis of self-report measures of mental and physical health found this group reported fewer needs than the remaining sample yet wanted more GP contact. The link between risk factors and healthcare professional involvement present in the rest of the sample was missing for these patients. Focus group data suggested practitioners found these patients challenging. Discussion This study identified patients with COPD who disavow their support needs, but who also desire more GP contact. GPs report finding these patients challenging to engage.

scholarly journals Open BIM-based quantity take-off system for schematic estimation of building frame in early design stage

2014 ◽  
Vol 2 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Jungsik Choi ◽  
Hansaem Kim ◽  
Inhan Kim
Keyword(s):  
Construction Projects ◽  
Design Stage ◽  
Prototype System ◽  
Construction Costs ◽  
Building Frame ◽  
Early Design ◽  
Early Design Stage ◽  
Construction Automation ◽  
Time Required ◽  
Stage 1

Abstract Since construction projects are large and complex, it is especially important to provide concurrent construction process to BIM models with construction automation. In particular, the schematic Quantity Take-Off (QTO) estimation on the BIM models is a strategy, which can be used to assist decision making in just minutes, because 70–80% of construction costs are determined by designers' decisions in the early design stage [1]. This paper suggests a QTO process and a QTO prototype system within the building frame of Open BIM to improve the low reliability of estimation in the early design stage. The research consists of the following four steps: (1) analyzing Level of Detail (LOD) at the early design stage to apply to the QTO process and system, (2) BIM modeling for Open BIM based QTO, (3) checking the quality of the BIM model based on the checklist for applying to QTO and improving constructability, and (4) developing and verifying a QTO prototype system. The proposed QTO system is useful for improving the reliability of schematic estimation through decreasing risk factors and shortening time required.

scholarly journals Bridging observational studies and randomized experiments by embedding the former in the latter

2017 ◽  
Vol 28 (7) ◽  
pp. 1958-1978 ◽  
Author(s):  
Marie-Abele C Bind ◽  
Donald B Rubin
Keyword(s):  
Statistical Analysis ◽  
Outcome Data ◽  
Design Stage ◽  
Randomized Experiment ◽  
Randomized Experiments ◽  
Causal Inferences ◽  
Data Set ◽  
Nominal Level ◽  
Point Estimates ◽  
Stage 1

Consider a statistical analysis that draws causal inferences from an observational dataset, inferences that are presented as being valid in the standard frequentist senses; i.e. the analysis produces: (1) consistent point estimates, (2) valid p-values, valid in the sense of rejecting true null hypotheses at the nominal level or less often, and/or (3) confidence intervals, which are presented as having at least their nominal coverage for their estimands. For the hypothetical validity of these statements, the analysis must embed the observational study in a hypothetical randomized experiment that created the observed data, or a subset of that hypothetical randomized data set. This multistage effort with thought-provoking tasks involves: (1) a purely conceptual stage that precisely formulate the causal question in terms of a hypothetical randomized experiment where the exposure is assigned to units; (2) a design stage that approximates a randomized experiment before any outcome data are observed, (3) a statistical analysis stage comparing the outcomes of interest in the exposed and non-exposed units of the hypothetical randomized experiment, and (4) a summary stage providing conclusions about statistical evidence for the sizes of possible causal effects. Stages 2 and 3 may rely on modern computing to implement the effort, whereas Stage 1 demands careful scientific argumentation to make the embedding plausible to scientific readers of the proffered statistical analysis. Otherwise, the resulting analysis is vulnerable to criticism for being simply a presentation of scientifically meaningless arithmetic calculations. The conceptually most demanding tasks are often the most scientifically interesting to the dedicated researcher and readers of the resulting statistical analyses. This perspective is rarely implemented with any rigor, for example, completely eschewing the first stage. We illustrate our approach using an example examining the effect of parental smoking on children’s lung function collected in families living in East Boston in the 1970s.

Novel Methodology for Inherent Safety Assessment in the Process Design Stage

2013 ◽  
Vol 52 (17) ◽  
pp. 5921-5933 ◽  
Author(s):  
Preeti Gangadharan ◽  
Ravinder Singh ◽  
Fangqin Cheng ◽  
Helen H. Lou
Keyword(s):  
Process Design ◽  
Safety Assessment ◽  
Design Stage ◽  
Inherent Safety

Inherent safety for sustainable process design of process piping at the preliminary design stage

2019 ◽  
Vol 209 ◽  
pp. 1307-1318 ◽  
Author(s):  
Muhammad Athar ◽  
Azmi Mohd Shariff ◽  
Azizul Buang ◽  
Muhammad Shuaib Shaikh ◽  
Tan Lian See
Keyword(s):  
Process Design ◽  
Design Stage ◽  
Preliminary Design ◽  
Inherent Safety ◽  
Process Piping ◽  
Preliminary Design Stage

Temperature Increase in Forming of Advanced High-Strength Steels Effect of Ram Speed Using a Servodrive Press

2016 ◽  
Vol 138 (9) ◽  
Author(s):  
Ali Fallahiarezoodar ◽  
Ruzgar Peker ◽  
Taylan Altan
Keyword(s):  
Process Design ◽  
Temperature Increase ◽  
High Strength Steels ◽  
High Strength ◽  
Design Stage ◽  
Interface Temperature ◽  
Fe Model ◽  
Advanced High Strength Steels ◽  
The Coefficient Of Friction ◽  
Ram Speed

In forming of advanced high-strength steel (AHSS), the temperature increase at die/sheet interface affects the performance of lubricants and die wear. This study demonstrates that finite-element (FE) analysis, using commercially available software, can be used to estimate temperature increase in single as well as in multiple stroke operations. To obtain a reliable numerical process design, the knowledge of the thermal and mechanical properties of the sheet as well as the tools is essential. Using U-channel drawing the thermomechanical FE model has been validated by comparing predictions with experimental results. The effect of ram speed and stroking rate (stroke per minute (SPM)) upon temperature increase in real productionlike operation have been investigated. Deep drawing of CP800 and DP590 sheets in a servodrive press, using an industrial scale die, has been studied. Thinning distribution and temperatures in the drawn part have been investigated in single and multiple forming operations. It is found that temperatures may reach several 100 deg and affect the coefficient of friction (COF). The values of COF under productionlike conditions were compared to that obtained from laboratory experiments. This study illustrates that in forming AHSS, (a) the temperature increase at the die/sheet interface is relatively high and should be considered in process design stage, and (b) the lubricant performance is significantly affected by the ram speed and sheet/die interface temperature during deformation.

A Comparative Assessment of Electronic and Pneumatic Controllers When Controlling Fast Processes Subject to Rapid Load Disturbance

1971 ◽  
Vol 4 (9) ◽  
pp. T147-T150
Author(s):  
M. S. Beck ◽  
F. M. Dadachanji
Keyword(s):  
Control Systems ◽  
Transmission Lines ◽  
Process Design ◽  
Comparative Assessment ◽  
Design Stage ◽  
Process Time ◽  
Accurate Information ◽  
Fast Process ◽  
Random Load ◽  
Process Control Systems

Experimental and analytical methods have been developed for measuring the performance, in an integral-square-error sense, of process control systems subject to random load disturbances. Results are given for the relative performance of pneumatic and electronic controllers when controlling a fast process (process time constant 1.3 s) subject to rapid load disturbances. It is shown that the performance of both types of controller is essentially the same when short lengths of pneumatic transmission line are used, but the performance of the pneumatic controller considerably deteriorates when longer transmission lines are used. The analytical method of performance assessment can give accurate information on controllability at the process design stage, provided that the process is linear about its operating point and that the transfer function is known.

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