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Process Validation for Solid Dosage Forms

Process Validation for Solid Dosage Forms

Articles | Quality Assurance    Date: 07-Dec-2013  Views: 2665
Process validation establishes the flexibility and constraints in the manufacturing process controls in the attainment of desirable attributes in the drug product while preventing undesirable properties. This is an important concept, since it serves to support the underlying definition of validation, which is a systematic approach to identifying, measuring, evaluating, documenting, and re-evaluating a series of critical steps in the manufacturing process that require control to ensure a reproducible final p
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Change Control Procedure in Pharmaceuticals

Change Control Procedure in Pharmaceuticals

Articles | Quality Assurance    Date: 26-Aug-2013  Views: 2160
Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Certain manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.Change is an inherent part of the life cycle of a pharmaceutical product. A change can be an addition to, deletion of, or modification to manufacturing facility, utilities, process, material, product, procedures or equipment (including
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Post Graduate Diploma in Quality Assurance & Quality Control

Post Graduate Diploma in Quality Assurance & Quality Control

Articles | Quality Assurance    Date: 16-Aug-2013  Views: 1298
The course targets graduate, post graduate and already employed candidates with keen interest in the Quality Assurance and Quality Control divisions of an industry. The postgraduate diploma course is aimed to make the participant learn the:
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List of Pharmaceutical Quality Assurance Books

List of Pharmaceutical Quality Assurance Books

Articles | Quality Assurance    Date: 13-Jul-2013  Views: 1117
New Books on Pharmaceutical Quality Assurance
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Process Validation : An Essential Process In Pharmaceutical Industry

Process Validation : An Essential Process In Pharmaceutical Industry

Articles | Quality Assurance    Date: 18-Mar-2013  Views: 2563
The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA). Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assur
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Quality Management Interview Questions & Answers

Quality Management Interview Questions & Answers

Articles | Quality Assurance    Date: 25-Jan-2013  Views: 14523
Free sample quality management/quality assurance interview questions and answersThe interview questions below can be used for quality positions such as: Quality/QA manager; Quality/QA assistant; Quality/QA supervisor; Quality/QA coordinator, quality engineer, quality analyst etc
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Difference between Validation VS Calibration

Difference between Validation VS Calibration

Articles | Quality Assurance    Date: 21-Jan-2013  Views: 10683
Validation is a documented program that provides high degree of assurance that a specific process, equipment, method or system consistently produces a result meeting pre-determined acceptance criteria.Calibration is a demonstration that, a particularInstrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
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Pharma Compliance & Validation Training / Education Courses

Pharma Compliance & Validation Training / Education Courses

Articles | Quality Assurance    Date: 15-Jan-2013  Views: 4443
Our wide range of residential pharmaceutical compliance and validation training / education courses are detailed below:Simple question, not always the easiest to answer. We can certainly help. Our pharmaceutical compliance and validation training / education courses and pharmaceutical consultancy services are all aimed at making this an easier question to answer. Please take the time to have a look at our services in more detail.
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 Quality Assurance (QA) Management Procedures

Quality Assurance (QA) Management Procedures

Articles | Quality Assurance    Date: 06-May-2012  Views: 7112
In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defect
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