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Pharmaceutical process validation

Author: Ira R Berry; Robert A Nash
Publisher: New York : Marcel Dekker, ©2003.
Series: Drugs and the pharmaceutical sciences, v. 129.
Edition/Format:   Print book : English : International 3rd ed., rev. and expandedView all editions and formats
Summary:
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
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Document Type: Book
All Authors / Contributors: Ira R Berry; Robert A Nash
ISBN: 0824708385 9780824708382
OCLC Number: 54001293
Description: xxxvi, 860 pages : illustrations ; 24 cm.
Contents: Regulatory basis for process validation --
Prospective process validation --
Retrospective validation --
Sterilization validation --
Validation of solid dosage forms --
Validation for medical devices --
Validation of biotechnology processes --
Transdermal process validation --
Validation of lyophilization --
Validation of inhalation aerosols --
Process validation of phamaceutical ingredients --
Qualification of water and air handling systems --
Equipment and facility qualification --
Validation and verification of cleaning processes --
Validation of analytical methods and processes --
Computer system validation: controlling the manufacturing process --
Integrated packaging validation --
Analysis of retrospective production data using quality control charts --
Statistical methods for uniformity and dissolution testing --
Change control and SUPAC --
Process validation and quality assurance --
Validation in contract manufacturing --
Terminology of nonaseptic proess validation --
Harmonization GMPs, and validation.
Series Title: Drugs and the pharmaceutical sciences, v. 129.
Responsibility: edited by Robert A. Nash, Alfred H. Wachter.
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Abstract:

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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Berry<\/span>\u00A0\u00A0\u00A0schema:contributor<\/a> <http:\/\/viaf.org\/viaf\/112376714<\/a>> ; # Robert A. Nash<\/span>\u00A0\u00A0\u00A0schema:copyrightYear<\/a> \"2003<\/span>\" ;\u00A0\u00A0\u00A0schema:datePublished<\/a> \"2003<\/span>\" ;\u00A0\u00A0\u00A0schema:description<\/a> \"Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0schema:description<\/a> \"The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0schema:exampleOfWork<\/a> <http:\/\/worldcat.org\/entity\/work\/id\/766881942<\/a>> ;\u00A0\u00A0\u00A0schema:inLanguage<\/a> \"en<\/span>\" ;\u00A0\u00A0\u00A0schema:isPartOf<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Series\/drugs_and_the_pharmaceutical_sciences<\/a>> ; # Drugs and the pharmaceutical sciences ;<\/span>\u00A0\u00A0\u00A0schema:name<\/a> \"Pharmaceutical process validation<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0schema:productID<\/a> \"54001293<\/span>\" ;\u00A0\u00A0\u00A0schema:publication<\/a> <http:\/\/www.worldcat.org\/title\/-\/oclc\/54001293#PublicationEvent\/new_york_marcel_dekker_2003<\/a>> ;\u00A0\u00A0\u00A0schema:publisher<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Agent\/marcel_dekker<\/a>> ; # Marcel Dekker<\/span>\u00A0\u00A0\u00A0schema:workExample<\/a> <http:\/\/worldcat.org\/isbn\/9780824708382<\/a>> ;\u00A0\u00A0\u00A0wdrs:describedby<\/a> <http:\/\/www.worldcat.org\/title\/-\/oclc\/54001293<\/a>> ;\u00A0\u00A0\u00A0\u00A0.<\/div>

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<http:\/\/dewey.info\/class\/615.10685\/e22\/<\/a>>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Agent\/marcel_dekker<\/a>> # Marcel Dekker<\/span>\u00A0\u00A0\u00A0\u00A0a bgn:Agent<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Marcel Dekker<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.<\/div>
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<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Series\/drugs_and_the_pharmaceutical_sciences<\/a>> # Drugs and the pharmaceutical sciences ;<\/span>\u00A0\u00A0\u00A0\u00A0a bgn:PublicationSeries<\/a> ;\u00A0\u00A0\u00A0schema:hasPart<\/a> <http:\/\/www.worldcat.org\/oclc\/54001293<\/a>> ; # Pharmaceutical process validation<\/span>\u00A0\u00A0\u00A0schema:name<\/a> \"Drugs and the pharmaceutical sciences ;<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.<\/div>
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<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/drug_industry_standards<\/a>> # Drug Industry--standards<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Drug Industry--standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/farmacia_analise<\/a>> # Farm\u00E1cia (an\u00E1lise)<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Farm\u00E1cia (an\u00E1lise)<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/industrie_pharmaceutique_qualite_controle<\/a>> # Industrie pharmaceutique--Qualit\u00E9--Contr\u00F4le<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Industrie pharmaceutique--Qualit\u00E9--Contr\u00F4le<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/medicaments_inspection_etats_unis<\/a>> # M\u00E9dicaments--Inspection--\u00C9tats-Unis<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"M\u00E9dicaments--Inspection--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/medicaments_normes_etats_unis<\/a>> # M\u00E9dicaments--Normes--\u00C9tats-Unis<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"M\u00E9dicaments--Normes--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/766881942#Topic\/quality_control<\/a>> # Quality Control<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Quality Control<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/id.loc.gov\/authorities\/subjects\/sh2008109170<\/a>> # Pharmaceutical industry--Quality control<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Pharmaceutical industry--Quality control<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/id.loc.gov\/authorities\/subjects\/sh2009123923<\/a>> # Drugs--Standards--United States<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Drugs--Standards--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
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<http:\/\/id.worldcat.org\/fast\/898923<\/a>> # Drugs--Standards<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Intangible<\/a> ;\u00A0\u00A0\u00A0schema:name<\/a> \"Drugs--Standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.<\/div>
<http:\/\/viaf.org\/viaf\/112376714<\/a>> # Robert A. Nash<\/span>\u00A0\u00A0\u00A0\u00A0a schema:Person<\/a> ;\u00A0\u00A0\u00A0schema:birthDate<\/a> \"1930<\/span>\" ;\u00A0\u00A0\u00A0schema:familyName<\/a> \"Nash<\/span>\" ;\u00A0\u00A0\u00A0schema:givenName<\/a> \"Robert A.<\/span>\" ;\u00A0\u00A0\u00A0schema:name<\/a> \"Robert A. Nash<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.<\/div>
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