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Critical Process Parameters
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes. Those attributes with a higher impact on CQAs should be prioritized and held in a stricter state of control. The manufacturer should conduct tests to set acceptable range limits of the determined CPPs and define acceptable process variable variability. Operational conditions within this range are considered acceptable operational standards. Any deviation from the acceptable range will be indicative of issues within the process and the subsequent production of substandard products. Data relating to CPP should be recorded, stored, and analyzed by the manufacturer. CPP variables and ranges should be reevaluated after careful analysis of historical CPP data. Identifying CPPs is done in stage one of process v ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Critical Quality Attributes
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. Process design In this stage, data from the development phase are gathered and analyzed to define the commercial manufacturing process. By understanding the commercial process, a framework fo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Process Validation
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. Process design In this stage, data from the development phase are gathered and analyzed to define the commercial manufacturing process. By understanding the commercial process, a framework fo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Process Design
In chemical engineering, process design is the choice and sequencing of units for desired physical and/or chemical transformation of materials. Process design is central to chemical engineering, and it can be considered to be the summit of that field, bringing together all of the field's components. Process design can be the design of new facilities or it can be the modification or expansion of existing facilities. The design starts at a conceptual level and ultimately ends in the form of fabrication and construction plans. Process design is distinct from equipment design, which is closer in spirit to the design of unit operations. Processes often include many unit operations. Documentation Process design documents serve to define the design and they ensure that the design components fit together. They are useful in communicating ideas and plans to other engineers involved with the design, to external regulatory agencies, to equipment vendors and to construction contractors ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Formal Methods
In computer science, formal methods are mathematically rigorous techniques for the specification, development, and verification of software and hardware systems. The use of formal methods for software and hardware design is motivated by the expectation that, as in other engineering disciplines, performing appropriate mathematical analysis can contribute to the reliability and robustness of a design. Formal methods employ a variety of theoretical computer science fundamentals, including logic calculi, formal languages, automata theory, control theory, program semantics, type systems, and type theory. Background Semi-Formal Methods are formalisms and languages that are not considered fully “formal”. It defers the task of completing the semantics to a later stage, which is then done either by human interpretation or by interpretation through software like code or test case generators. Taxonomy Formal methods can be used at a number of levels: Level 0: Formal specification may ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Enterprise Modelling
Enterprise modelling is the abstract representation, description and definition of the structure, processes, information and resources of an identifiable business, government body, or other large organization. It deals with the process of understanding an organization and improving its performance through creation and analysis of enterprise models. This includes the modelling of the relevant business domain (usually relatively stable), business processes (usually more volatile), and uses of information technology within the business domain and its processes. Overview Enterprise modelling is the process of building models of whole or part of an enterprise with process models, data models, resource models and/or new ontologies etc. It is based on knowledge about the enterprise, previous models and/or reference models as well as domain ontologies using model representation languages. F.B. Vernadat (1997)Enterprise Modelling Languages ICEIMT'97 Enterprise Integration - Internation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function. Evolution Quality management is a recent phenomenon but important for an organization. Civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards than normal goods. In societies where arts and crafts ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Business Process
A business process, business method or business function is a collection of related, structured activities or tasks by people or equipment in which a specific sequence produces a service or product (serves a particular business goal) for a particular customer or customers. Business processes occur at all organizational levels and may or may not be visible to the customers. A business process may often be visualized (modeled) as a flowchart of a sequence of activities with interleaving decision points or as a process matrix of a sequence of activities with relevance rules based on data in the process. The benefits of using business processes include improved customer satisfaction and improved agility for reacting to rapid market change. Process-oriented organizations break down the barriers of structural departments and try to avoid functional silos. Overview A business process begins with a mission objective (an external event) and ends with achievement of the business object ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
