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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] |
Pharmaceutical Manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace parts more often, or it results in a non-homogeneous reaction. Finally, lower temperatures can result in crusting of reagents, intermediates, and byproducts to the reaction vessel over time, which will impact the purity of the product. Stoichiometry Different stoichiometric ratios of reagents can ... [...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 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] |
Installation Qualification
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other ide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Qualification
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other ide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Performance Qualification
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other ide ... [...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] |
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] |