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- Validation_master_plan abstract "A Validation Master Plan, also referred to as \"VMP\", outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects. Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's validation strategy is well thought-out and organized. A VMP should have logical reasoning for including or excluding every system associated with a validation projectbased on a risk assessment. Common topics to be covered in a Validation Master Plan:Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system, ventilation and air-conditioning system, clean steam, compressed air, gases and vacuum system, list manufacturing equipment, building management systems, products that are planned to be validated, qualification/validation approach, process validation and cleaning validation approach, microbiological monitoring, computer Validation, calibration, maintenance, related SOPs.".
- Validation_master_plan wikiPageExternalLink farmavitar.com.
- Validation_master_plan wikiPageID "19318850".
- Validation_master_plan wikiPageLength "2084".
- Validation_master_plan wikiPageOutDegree "4".
- Validation_master_plan wikiPageRevisionID "695592670".
- Validation_master_plan wikiPageWikiLink Category:Pharmaceutical_industry.
- Validation_master_plan wikiPageWikiLink Cleaning_validation.
- Validation_master_plan wikiPageWikiLink Good_manufacturing_practice.
- Validation_master_plan wikiPageWikiLink Validation_(drug_manufacture).
- Validation_master_plan wikiPageWikiLinkText "Validation master plan".
- Validation_master_plan wikiPageUsesTemplate Template:No_footnotes.
- Validation_master_plan subject Category:Pharmaceutical_industry.
- Validation_master_plan type Industry.
- Validation_master_plan type Pharmaceutic.
- Validation_master_plan type Redirect.
- Validation_master_plan comment "A Validation Master Plan, also referred to as \"VMP\", outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.".
- Validation_master_plan label "Validation master plan".
- Validation_master_plan sameAs Q7911675.
- Validation_master_plan sameAs m.04lg07d.
- Validation_master_plan sameAs Q7911675.
- Validation_master_plan wasDerivedFrom Validation_master_plan?oldid=695592670.
- Validation_master_plan isPrimaryTopicOf Validation_master_plan.