Process qualities

Transfer function models are linear in nature, but chemical processes are known to exhibit nonhnear behavior. One could use the same type of optimization objective as given in Eq. (8-26) to determine parameters in nonlinear first-principle models, such as Eq. (8-3) presented earlier. Also, nonhnear empirical models, such as neural network models, have recently been proposed for process applications. The key to the use of these nonlinear empirical models is naving high-quality process data, which allows the important nonhnearities to be identified. 

Effective procedure training not only affects process safety, it also affects quality. Process yields, batch turnaround time, and equipment cleaning are all enhanced when the procedures are technically accurate and fully understood by the crews. 

All of the components should be incorporated in the quality process, not just a few. 

A key aspect of this quality process component is to evaluate if the people doing the job have access to and are following the established procedures. There should be a system to manage the updating of procedures, communicating the changes, and training personnel on the procedures. 

Accountability Objectives and Goals Continuity of operations Continuity of systems (resources and funding) Continuity of organizations Company expectations (vision or master plan) Quality process Control of exceptions... 

Chemical processes invariably require large quantities of water for cooling and general process use, and the plant must be located near a source of water of suitable quality. Process water may be drawn from a river, from wells, or purchased from a local authority. 

The HSP Quality Model (4). It simulates a comprehensive set of water quality processes in streams and lakes, but not pesticides and toxic substances. 

Energy efficient process High quality processes... 

Accountability Objectives and Goals—This element encompasses continuity of operations, continuity of systems (resources and funding), continuity of organizations, company expectations (vision and master plan), the quality process, control of expectations, alternative methods, management accessibility, and communications. 

In addition to the primary processes, the following secondary processes are present in all three companies maintenance, quality and logistics. These processes together with the primary process constitute the operational process, where the initial data for this study was collected. The maintenance process performs scheduled and unscheduled maintenance activities at the different technical installations. The quality process takes samples at different points in the primary process to check the intermediate or final product according to product specifications. The logistic process takes care of the material flow and storage of materials. 

Host Cell Impurities Various organisms have been used to produce recombinant proteins yeast, bacteria (e.g., E. coli), insect cells, and mammalian cells such as Chinese hamster ovary (CHO) cells. During the purification process, some HCPs can copurify with the protein product. Because of the specificity of the antigen-antibody interaction, an ELISA can be used to detect and quantitate the contaminating HCPs. Detecting host impurities is important for quality process control as well as for product safety issues. The intent is to avoid unsafe levels of residual HCPs which might lead to adverse reactions.11... 

It is vitally important that the multivariate nature of data related to a process be assessed to develop an understanding of a process and to assess quality. Process data together with appropriate chemometric models can provide information about (1) product quality inferentially from process conditions (2) process consistency (process signature, statistical process control) (3) analyzer reliability and (4) operational knowledge that can aid in scale-up and process transfers. ... 

Do we have a quality process for rapid product development and market penetration Do we have a stream of product improvements Are we develop-ing common platforms for families of products (37) Are we developing improved processes concurrently with our new products How do we maintain our manufacturing processes at wodd-dass levels (Fig. 5) (38) ... 

Drugs which are manufactured not in accordance with any cGMP requirement, including the quahty control and quality process mandates, are adulterated under the FDCA. Section 351 of 21 U.S.C. defines a drug as adulterated... 

First, we will discuss a few important definitions that closely relate to ISO 9000 2000 (quality process modeling) standard principle 4 ... 

Establishing an organization to lead the systems initiative is important. That organization requires management, standards, and parameters similar to managing an individual quality process. It requires roles and responsibilities be established,... 

The guiding principle of metric development is to have a stable system or process to collect, review, and draw conclusions. All metrics should be developed with stakeholders input taking into account the requirements and needs of the customers. This includes the touch points of the downstream quality processes. Without this input and understanding metrics may be developed within a silo and hold little value, causing both frustration at the leadership as well as the staff level. Without proper... 

TABLE 1 Basic Quality Process Improvement Tools during Process Diagnosis... 

Normal Probability Plot The normal probability plot is a graphical technique for assessing whether or not a data set is approximately normally distributed. The data are plotted against a theoretical normal distribution in such a way that the points form an approximate straight line. Departures from this straight line indicate departures from normality. The normal probability plot is important for quality process improvement since many other tools require the normality assumption. A normal... 

---