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Process Performance Qualification Protocol
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process. The Food and Drug Administration recommends the following criteria be included in a PPQ protocol: *Manufacturing conditions: Operating parameters, equipment limits, and component inputs *What data should be recorded and analyzed *What tests should be performed to ensure quality at each production step *A sampling plan to outline sampling methods both during and between production batches *Analysis methodology that allows for data scientific and risk oriented decision making based on statistical data. Variability limits should be defined and contingencies in the event of non-conforming data established *Approval of PPQ protocol from relevant departments Deviations from the standar ... [...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 Qualification
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. This may include testing equipment at maximum operating capacity to show quantity demands can be met. Once all processes have been qualified the manufacturer should have a complete understanding of the process design and have a framework in place to routinely monitor operations. Only after process qualification has been completed can the manufacturing process begin production for commercial use. Equally important as qualifying processes and equipment is qualifying software and personnel. A well trained staff and accurate, thorough records helps ensure ongoing protection from process faults and quick recovery from otherwise costly process malfunctions. I ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introduction Ea ... [...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] |
Business Process Management
Business process management (BPM) is the discipline in which people use various methods to discover, model, analyze, measure, improve, optimize, and automate business processes. Any combination of methods used to manage a company's business processes is BPM. Processes can be structured and repeatable or unstructured and variable. Though not required, enabling technologies are often used with BPM. It can be differentiated from program management in that program management is concerned with managing a group of inter-dependent projects. From another viewpoint, process management includes program management. In project management, process management is the use of a repeatable process to improve the outcome of the project. Key distinctions between process management and project management are repeatability and predictability. If the structure and sequence of work is unique, then it is a project. In business process management, a sequence of work can vary from instance to instance: t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Validity (statistics)
Validity is the main extent to which a concept, conclusion or measurement is well-founded and likely corresponds accurately to the real world. The word "valid" is derived from the Latin validus, meaning strong. The validity of a measurement tool (for example, a test in education) is the degree to which the tool measures what it claims to measure. Validity is based on the strength of a collection of different types of evidence (e.g. face validity, construct validity, etc.) described in greater detail below. In psychometrics, validity has a particular application known as test validity: "the degree to which evidence and theory support the interpretations of test scores" ("as entailed by proposed uses of tests"). It is generally accepted that the concept of scientific validity addresses the nature of reality in terms of statistical measures and as such is an epistemological and philosophical issue as well as a question of measurement. The use of the term in logic is narrower, relati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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