|
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 (Stage 1a, Stage 1b), process qualification (Stage 2a, Stage 2b), and continued process verification (Stage 3a, Stage 3b). Stage 1: Process Design In this stage, data from the development phase are gathered and analyzed to define the commercial manufac ... [...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 pharmaceutical 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 ... [...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 European Medicines Agency, 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 (Stage 1a, Stage 1b), process qualification (Stage 2a, Stage 2b), and continued process verification (Stage 3a, Stage 3b). Stage 1: Process Design In this stage, data from the development phase are gathered and analyzed to de ... [...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's 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 the 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's inner structure, its source code (see Software metrics), at the unit level, and at the system level (sometimes referred to as end-to-end testin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Formal Methods
In computer science, formal methods are mathematics, mathematically rigorous techniques for the formal specification, specification, development, Program analysis, analysis, and formal verification, verification of software and computer hardware, 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 in computer science, logic calculi, formal languages, automata theory, control theory, program semantics, type systems, and type theory. Uses Formal methods can be applied at various points through the software development process, development process. Specification Formal methods may be used to give a formal description of the system to be developed, at whatever level of detail desired. F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Testing
Software testing is the act of checking whether software satisfies expectations. Software testing can provide objective, independent information about the Quality (business), quality of software and the risk of its failure to a User (computing), user or sponsor. Software testing can determine the Correctness (computer science), correctness of software for specific Scenario (computing), scenarios but cannot determine correctness for all scenarios. It cannot find all software bug, bugs. Based on the criteria for measuring correctness from an test oracle, oracle, software testing employs principles and mechanisms that might recognize a problem. Examples of oracles include specifications, Design by Contract, contracts, comparable products, past versions of the same product, inferences about intended or expected purpose, user or customer expectations, relevant standards, and applicable laws. Software testing is often dynamic in nature; running the software to verify actual output ... [...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 specification (technical standard), 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 reality, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, A Guide to the Project Management Body of Knowledge, 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 assu ... [...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] |
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 r ... [...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 manageme ... [...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 contracto ... [...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] |
