Solid oral dose process validation : the basics.: the basics. Volume 1 ([2018])

• Record Type: Book
• Further Information: Note: Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins.
• Authors: Pazhayattil, Ajay Babu; Sayeed-Desta, Naheed; Fredro-Kumbaradzi, Emilija; Collins, Jordan
• Contents: Chapter 1: Lifecycle Approach to Process ValidationProcess Validation StagesAuxiliary Programs Supporting Lifecycle Process ValidationRegulatory RequirementsChapter 2: Solid Dose FormulationsTabletsTablet Manufacturing ProcessesCapsulesCapsule Manufacturing ProcessChapter 3: Stage 1A Process Design: Quality by DesignQuality Target Product Profile (QTPP)Critical Quality Attributes (CQAs)Critical Material Attributes (CMAs)Critical Process Parameters (CPPs)8Design of Experiments (DoE)Control Strategy (CS)Process Capability and Continual ImprovementChapter 4: Knowledge Management and Risk Assessment for Lifecycle StagesKnowledge Base for DevelopmentICH Q9 Quality Risk ManagementDesign SpaceChapter 5: Stage 1B Process Scale-Up ConsiderationsProcess Scale-Up StudiesControl Strategy ComponentsChapter 6:Stage 2A and Stage 2B: Process QualificationStage 2A- Design and Qualification of the Facility, Equipment andUtilitiesTechnology Transfer ConsiderationsChecklist Prior to Initiating Stage 2BStage 2B- Process Performance QualificationChapter 7: Stage 3A and Stage 3B: Continued Process VerificationBenefits of Continued Process Verification ProgramContinued Process Verification Stage 3AContinued Process Verification Stage 3B.ICH Guidance's working in tandem.
• Publisher Details: Cham, Switzerland : AAPS Springer
• Publication Date: 2018
• Copyright Date: 2018
• Extent: 1 online resource
• Subjects: 615.19; Solid dosage forms; Drugs; Pharmaceutical chemistry; Pharmaceutical technology; MEDICAL / Pharmacology; Drugs; Pharmaceutical chemistry; Pharmaceutical technology; Solid dosage forms; Electronic books
• Languages: English
• ISBNs: 9783030024727; 3030024725
• Related ISBNs: 9783030024710
• Notes: Note: Includes bibliographical references and index.; Note: Vendor-supplied metadata.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.