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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] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ... [...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] |
Software Quality
In the context of software engineering, software quality refers to two related but distinct notions: * Software functional quality reflects how well it complies with or conforms to a given design, based on functional requirements or specifications. That attribute can also be described as the fitness for purpose of a piece of software or how it compares to competitors in the marketplace as a worthwhile product. It is the degree to which the correct software was produced. * Software structural quality refers to how it meets non-functional requirements that support the delivery of the functional requirements, such as robustness or maintainability. It has a lot more to do with the degree to which the software works as needed. Many aspects of structural quality can be evaluated only statically through the analysis of the software inner structure, its source code (see Software metrics), at the unit level, system level (sometimes referred to as end-to-end testing), which is in effect ... [...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] |
Software Testing
Software testing is the act of examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to appreciate and understand the risks of software implementation. Test techniques include, but not necessarily limited to: * analyzing the product requirements for completeness and correctness in various contexts like industry perspective, business perspective, feasibility and viability of implementation, usability, performance, security, infrastructure considerations, etc. * reviewing the product architecture and the overall design of the product * working with product developers on improvement in coding techniques, design patterns, tests that can be written as part of code based on various techniques like boundary conditions, etc. * executing a program or application with the intent of examining behavior * reviewing the deployment infrastructure a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Verification And Validation
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 iden ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cleaning Validation
Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by residues from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a good manufacturing practice requirement. The U.S. Food and Drug Administration (FDA) has strict regulations about cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Business Process Validation
Business Process Validation (BPV) is the act of verifying that a set of end-to-end business processes function as intended. If there are problems in one or more business applications that support a business process, or in the integration or configuration of those systems, then the consequences of disruption to the business can be serious. A company might be unable to take orders or ship product – which can directly impact company revenue, reputation, and customer satisfaction. It can also drive additional expenses, as defects in production are much more expensive to fix than if identified earlier. For this reason, a key aim of Business Process Validation is to identify defects early, before new enterprise software is deployed in production so that there is no business impact and the cost of repairing defects is kept to a minimum. Note: BPV is unrelated to Validation (drug manufacture) by the U.S. Food and Drug Administration. During Business Process Validation (BPV), the busines ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
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] |
Continued Process Verification
Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation. Its central purpose is to ensure that processes are in a constant state of control, thus ensuring final product quality. Central to effective CPV is a method with which to identify unwanted process inconsistencies in order to execute corrective or preventive measures. Once quality standards are set in place they must be monitored with regular frequency to confirm those parameters are being met. Continued process verification not only helps protect consumers from production faults, but business also see benefits in implementing a CPV program. Shou ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
