BIOTECHNOLOGY VALIDATION DOCUMENTATION.

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Biotechnology and GMP.

Biotechnology, pharmaceutical, and medical device facilities must comply with the FDA’s current Good Manufacturing Practices (cGMPs). Biotechnology validation ensures that that a facility’s design and operation is in accord with regulatory requirements as documented in GMLs.

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Validation Master Plan.

Validation Plan.

Design Qualification.

User Requirements Specification.

Installation Qualification.

Operational Qualification.

Performance Qualification.

Process Qualification.

Vendor Audit

SOP for cGMP

SOP for Writing SOP

Gap Analysis

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Validation Master Plan.

Validation Plan.



Process Validation Requirements.

Validation is a dynamic process. It is expected to follow a timeline stretching from initial design through to production.  Typical expectations are that design qualification (DQ), installation qualification (IQ), and operational qualification (OQ) should be nearly complete early in the development process, at phase 1 and 2. Process qualification (PQ) should be complete at end of phase 3. But everything evolves with the process, and that process is usually a moving target until registration.

A frequent problem is the failure to address the life cycle of the system as a whole — most biotechnology validation efforts focus on individual subcomponents of the process and stop after the specified number of process runs that are required to gain qualification.  For successful biotechnology validation of Processes used in the manufacture of drug products, the regulators expect validation of all manufacturing steps: cleaning, weighing, measuring, mixing, blending, filling,


Links to Associated Subjects.


Bioinformatics,   Biomedical,   Cheminformatics,   Fire protection engineering,   Health technologies,   Medical technology,   Nutrition,   Pharmaceuticals,   Safety engineering,   Sanitary engineering.


Useful Links and Cross-references.

AccreditationChange controlCertification of voting machinesComparabilityCross-validationFormal verificationIndependent Verification and Validation FacilityIntegrity TestingISO 17025Specification (technical standard)System testingSyncretismUsability testingValidationValidation (drug manufacture)VerificationVerification and Validation (software)Biological systems engineeringConfiguration managementEarth systems engineering and managementEnterprise systems engineeringPerformance engineeringReliability engineeringSafety engineeringSpace Systems EngineeringRequirements analysisFunctional specificationSystem integrationDesign reviewBusiness processSystemSystems engineering processSystem lifecycleSystems Development Life CycleSystems Modeling LanguageIDEFDecision makingFunctional modellingOptimizationPlanningReliable analysisStatistical analysisSystems analysisSystem dynamicsSystems modelingV-ModelWork breakdown structureWernher von BraunHarold ChestnutArthur David Hall IIIDerek HitchinsRobert E. MacholSimon RamoJoseph Francis SheaJohn N. WarfieldControl engineeringComputer engineeringIndustrial engineeringOperations researchProject managementQuality managementSoftware engineering.



BIOTECHNOLOGY VALIDATION DOCUMENTATION.



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