Process Performance Assessment

Improving the Regulatory Review Process Assessing Performance and... 

A failure modes and effects analysis is a systematic analytical technique for identifying potential failures in a design or a process, assessing the probability of occurrence and likely effect, and determining the measures needed to eliminate, contain, or control the effects. Action taken on the basis of an FMEA will improve safety, performance, reliability, maintainability and reduce costs. The outputs are essential to balanced and effective quality plans for both development and production as it will help focus the controls upon those products, processes, and characteristics that are at risk. It is not the intention here to give a full appreciation of the FMEA technique and readers are advised to consult other texts. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

Over the last quarter century the dissolution test has emerged as a most powerful and valuable tool to guide formulation development, monitor the manufacturing process, assess product quality, and in some cases to predict in vivo performance of solid oral dosage forms. Under certain conditions, the dissolution test can be used as a surrogate measure for bioequivalence (BE) and to provide biowaivers, assuring BE of the product. Dissolution test has turned out to be a... 

In most cases, a team of development chemists, engineers, and safety personnel evaluate and assess hazards associated with each and every step of a process, from performing a reaction to storage of waste streams in drums. The team recommends a set of safety experiments to be conducted, and data are collected for reaction exo-... 

In 1995, the US-EPA updated and issued the current Agency-wide Risk Characterization Policy (US-EPA 1995). The Policy called for all risk assessments performed at US-EPA to include a risk characterization to ensure that the risk assessment process is transparent. It also emphasized that risk assessments should be clear, reasonable, and consistent with other risk assessments of similar scope prepared by programs across the Agency. 

Analysis of the solid and liquid process waste streams clearly indicates that the MCC process offers environmental benefits compared with the chemical resolution procedure. To generate data for the cradle-to-grave emissions and impacts, a streamlined life cycle assessment of all of the processes was performed using the Fast Lifecycle Assessment for Synthetic Chemistry, FLASC . 

The economic feasibility of the process should be established at this stage. Again, this is only an introductory assessment performed more to establish that the plant is not definitely a loss-maker, rather than deciding that it is a particularly attractive proposition. A full and detailed economic evaluation of the plant and process is performed later in the design study (see Chapter 6) after the process route has been finalised, a detailed equipment listing prepared, and preliminary equipment designs have been performed. The following steps need to be performed to establish the economic feasibility of the process ... 

Process Control Performance Assessment Andrzej W. Ordys, Damien Uduehi and Michael A. Johnson (Eds.)... 

Life-cycle assessment methodology has been used since the 1960s with early studies that focused solely on energy usage and solid waste issues. This focus continued in life-cycle assessments performed during the oil crisis in the 1970s.86>87 The unique aspect of all of these initial studies was the early development and use of life-cycle data inventories with less emphasis on environmental risk impacts of the associated processes studied. A method published by the Royal Commission on Environmental Pollution in 1988, employing the Best Practicable Environmental... 

While all GxP data should be checked for correctness, it may be possible to justify a sample check for other data categories if a business case can be made to justify the omission of checks on all records. Some regulators require a double check for GxP data entry. Such checks should immediately follow the data entry and precede any further processing of the data. Where this is not possible, checking must be conducted as soon as possible and a risk assessment performed to address the potential consequences of erroneous data input. 

The benefits to process safety are obvious since eliminating equipment failures removes potential causes for losing control of the process, losing containment of hazardous materials, and the necessity for nonroutine operations. Successfully implementing reliability programs depends upon collecting the proper data to assess performance and maintain reliable, dependable practices. Superior... 

Performance is the one issue in which cosmetics and drugs are different. Drug efficacy is assessed on the basis of cure or prevention of disease. The FDA has established that cosmetic products that exert therapeutic effects are drugs. As a result, some traditional cosmetics were converted into drugs via the OTC panel process. Any performance claims for these OTC products are limited to the wording approved during the OTC review process. 

Tasks perform their function by the execution of processes. Each task contains several types of processes. The precondition process assesses whether or not the task can play a sensible role in the current context. The action process performs the primary work of the task, which can include scheduling subtasks to be run next. The monitor process executes between each of the subtasks, typically to assess their result. Finally, the postcondition process assesses the success of the task as a whole immediately prior to completion. 

The second step is to honestly and accurately assess one s current state. The performance of process assessments has proven to be an effective tool for doing this. This method differs significantly from the traditional compliance audit. It focuses on efficiency as well as effectiveness in achieving standards. It looks beyond observations or symptoms for root causes. It focuses on the quality of the processes and their outputs. It borrows from the Malcolm Baldrige award the evaluation of ... 

The original manufacturing formula (HV) and five variations are performed in the first step of the synthesis. Six samples are analysed. The results of these six analyses are used to assess the validation of this process step. In this case validation of the analytical method is a prerequisite for any decision that is made about the validity of the process. This information is needed before the process research chemist can start variations of the process otherwise it is possible that the data received cannot be assessed. The difficulty of assessing the data of the process validation results from the fact that the data is influenced by the analytical method and the uncertainty of the chemical process. If the uncertainty of the analytical method is larger or in the same range as the variations of the chemical process, assessment of the data is not possible. 

Sustainability is important in the context of industry sectors, products, process technologies, and individual process plants. In assessing performance achievement in sustainability, there is a need for suitable sustainability indicators to measure progress in environmental, economic, and social performance. 

The selection of an appropriate fixed bed reactor design for a given process is performed assessing the main limitations of these reactors. The fixed packed bed reactors can be malfunctioning due to improper temperature control, pressure drop for processes with low tolerance, and deactivation of the catalyst. 

---