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010   $a3-030-02472-5
024 7 $a10.1007/978-3-030-02472-7
035   $a(CKB)4100000007142768
035   $a(MiAaPQ)EBC5598976
035   $a(DE-He213)978-3-030-02472-7
035   $z(PPN)258872322
035   $a(PPN)232472823
035   $a(EXLCZ)994100000007142768
100   $a20181116d2018      u|         0
101 0 $aeng
135   $aurcnu||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aSolid Oral Dose Process Validation $eThe Basics, Volume 1 /$fby Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
205   $a1st ed. 2018.
210  1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2018.
215   $a1 online resource (99 pages)
225 1 $aAAPS Introductions in the Pharmaceutical Sciences,$x2522-834X
311   $a3-030-02471-7 
327   $aVolume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification.
330   $aCurrently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance?s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
410  0$aAAPS Introductions in the Pharmaceutical Sciences,$x2522-834X
606   $aPharmaceutical technology
606   $aPharmacy
606   $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010
606   $aPharmacy$3https://scigraph.springernature.com/ontologies/product-market-codes/F00008
615  0$aPharmaceutical technology.
615  0$aPharmacy.
615 14$aPharmaceutical Sciences/Technology.
615 24$aPharmacy.
676   $a615.19
700   $aPazhayattil$b Ajay Babu$4aut$4http://id.loc.gov/vocabulary/relators/aut$01057742
702   $aSayeed-Desta$b Naheed$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aFredro-Kumbaradzi$b Emilija$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aCollins$b Jordan$4aut$4http://id.loc.gov/vocabulary/relators/aut
906   $aBOOK
912   $a9910298400003321
996   $aSolid Oral Dose Process Validation$92494377
997   $aUNINA