Side-by-Side Comparison 21 CFR, Parts 110, 111, 211 And 820
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSPart 110 - CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKING, ORHOLDING HUMAN FOODPart 111 - CURRENT GOOD MANUFACTURINGPRACTICE IN MANUFACTURING, PACKAGING,LABELING, OR HOLDING OPERATIONS FORDIETARY SUPPLEMENTSPart 211 - CURRENT GOODMANUFACTURING PRACTICE FORFINISHED PHARMACEUTICALSPart 820 (Devices) QUALITY SYSTEMREGULATIONGeneralProvisionsSubpart A--General Provisions§ 110.3 - Definitions.§ 110.5 - Current goodmanufacturingSubpart A--General Provisions§ 111.1 - Who is subject to this part?§ 111.3 - What definitions apply to this part?§ 111.5 - Do other statutory provisions andregulations apply?Subpart A--General Provisions§ 211.1 - Scope.§ 211.3 - Definitions.Subpart A--GeneralProvisions§ 820.1 - Scope.§ 820.3 - Definitions.Subpart B--Personnel§ 111.8 - What are the requirements under thissubpart B for written procedures?§ 111.10 - What requirements apply forpreventing microbial contamination from sick orinfected personnel and for hygienic practices?§ 111.12 - What personnel qualificationrequirements apply?§ 111.13 - What supervisor requirements apply?§ 111.14 - Under this subpart B, what recordsmust you make and keep?Subpart B--Organization and Personnel§ 211.22 - Responsibilities of qualitycontrol unit.§ 211.25 - Personnel qualifications.§ 211.28 - Personnel responsibilities.§ 211.34 - Consultants.Subpart B--QualitySystem Requirements§ 820.20 Managementresponsibility.§ 820.25 Personnel.PersonnelBuilding andFacilitySubpart B--Buildings and Facilities§ 110.20 - Plant and grounds.§ 110.35 - Sanitary operations.§ 110.37 - Sanitary facilities andcontrols.Subpart C--Physical Plant and Grounds§ 111.15 - What sanitation requirements apply toyour physical plant and grounds?§ 111.16 - What are the requirements under thissubpart C for written procedures?§ 111.20 - What design and constructionrequirements apply to your physical plant?§ 111.23 - Under this subpart C, what recordsmust you make and keep?Subpart C--Buildings and Facilities§ 211.42 - Design and constructionfeatures.§ 211.44 - Lighting.§ 211.46 - Ventilation, air filtration, airheating and cooling.§ 211.48 - Plumbing.§ 211.50 - Sewage and refuse.§ 211.52 - Washing and toilet facilities.§ 211.56 - Sanitation.§ 211.58 - Maintenance.EquipmentSubpart C--Equipment§ 110.40 - Equipment and utensils.Subpart D--Equipment and Utensils§ 111.25 - What are the requirements under thissubpart D for written procedures?§ 111.27 - What requirements apply to theequipment and utensils that you use?§ 111.30 - What requirements apply toautomated, mechanical, or electronic equipment?§ 111.35 - Under this subpart D, what recordsmust you make and keep?Subpart D--Equipment§ 211.63 - Equipment design, size, andlocation.§ 211.65 - Equipment construction.§ 211.67 - Equipment cleaning andmaintenance.§ 211.68 - Automatic, mechanical, andelectronic equipment.§ 211.72 - Filters.Subpart G-Production andProcess Controls§ 820.70(f)- BuildingsSubpart G-Production andProcess Controls§ 820.70(g)EquipmentDefect andActions LevelsSubpart G--Defect Action Levels§ 110.110 - Natural or unavoidabledefects in food for human use thatpresent no health hazard.REGULATIONSPart 110 - CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKING, ORHOLDING HUMAN FOODPart 111 - CURRENT GOOD MANUFACTURINGPRACTICE IN MANUFACTURING, PACKAGING,LABELING, OR HOLDING OPERATIONS FORDIETARY SUPPLEMENTSPart 210, Part 211 - CURRENT GOODMANUFACTURING PRACTICE FORFINISHED PHARMACEUTICALSPart 820 - QUALITYSYSTEMREGULATIONProduction andProcess ControlSubpart E--Productionand Process Controls§ 110.80 - Processes andcontrols.Subpart E--Requirement to Establish a Productionand Process Control System§ 111.55 - What are the requirements toimplement a production and process controlsystem?§ 111.60 - What are the design requirements forSubpart E--Control of Components andDrug Product Containers and Closures§ 211.80 - General requirements.§ 211.82 - Receipt and storage ofuntested components, drug productcontainers, and closures.Subpart C--DesignControls§ 820.30 - Designcontrols.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820§ 110.93 - Warehousingand distribution.the production and process control system?§ 111.65 - What are the requirements for qualitycontrol operations?§ 111.70 - What specifications must youestablish?§ 111.73 - What is your responsibility fordetermining whether established specifications aremet?§ 111.75 - What must you do to determinewhether specifications are met?§ 111.77 - What must you do if establishedspecifications are not met?§ 111.80 - What representative samples mustyou collect?§ 111.83 - What are the requirements for reservesamples?§ 111.87 - Who conducts a material review andmakes a disposition decision?§ 111.90 - What requirements apply totreatments, in-process adjustments, andreprocessing when there is a deviation orunanticipated occurrence or when a specificationestablished in accordance with 111.70 is not met?§ 111.95 - Under this subpart E, what recordsmust you make and keep?§ 211.84 - Testing and approval orrejection of components, drug productcontainers, and closures.§ 211.86 - Use of approvedcomponents, drug product containers, andclosures.§ 211.87 - Retesting of approvedcomponents, drug product containers, andclosures.§ 211.89 - Rejected components, drugproduct containers, and closures.§ 211.94 - Drug product containers andclosures.DocumentControlsSubpart D--DocumentControls§ 820.40 - Documentcontrols.PurchasingControlsSubpart E--PurchasingControls§ 820.50 Purchasing controls.Identificationand TraceabilitySubpart F-Identification andTraceability§ 820.60 Identification.§ 820.65 Traceability.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSQuality ControlPart 110 CURRENT GOODMANUFACTURINGPRACTICE INMANUFACTURING,PACKING, ORHOLDING HUMANFOODPart 111 - CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKAGING,LABELING, OR HOLDING OPERATIONSFOR DIETARY SUPPLEMENTSPart 210, Part 211 - CURRENTGOOD MANUFACTURINGPRACTICE FOR FINISHEDPHARMACEUTICALSSubpart F--Production and ProcessControl System: Requirements forQuality Control§ 111.103 - What are the requirementsunder this subpart F for written procedures?§ 111.105 - What must quality controlpersonnel do?§ 111.110 - What quality controloperations are required for laboratoryoperations associated with the productionand process control system?§ 111.113 - What quality controloperations are required for a materialreview and disposition decision?§ 111.117 - What quality controloperations are required for equipment,instruments, and controls?§ 111.120 - What quality controloperations are required for components,packaging, and labels before use in themanufacture of a dietary supplement?§ 111.123 - What quality controloperations are required for the mastermanufacturing record, the batch productionrecord, and manufacturing operations?§ 111.127 - What quality controloperations are required for packaging andlabeling operations?§ 111.130 - What quality controloperations are required for returned dietarysupplements?§ 111.135 - What quality controloperations are required for productcomplaints?§ 111.140 - Under this subpart F, whatrecords must you make and keep?Subpart B--Organizationand Personnel§ 211.22 - Responsibilitiesof quality control unit.Part 820 - QUALITY SYSTEMREGULATIONSubpart A--General Provisions§ 820.5 - Quality system.Subpart B--Quality System Requirements§ 820.22 - Quality audit.AcceptanceActivitiesSubpart H--Acceptance Activities§ 820.80 - Receiving, in-process, andfinished device acceptance.§ 820.86 - Acceptance status.NonconformingProductsSubpart I--Nonconforming Product§ 820.90 - Nonconforming product.Corrective andPreventiveActionSubpart J--Corrective and PreventiveAction§ 820.100 - Corrective and preventiveaction.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSPackaging andLabelingControls ProductReceived forPackagingProductionProcess ControlMasterDocumentProduction andProcess BatchProductionPart 110 - CURRENTGOODMANUFACTURINGPRACTICE INMANUFACTURING,PACKING, ORHOLDING HUMANFOODPart 111 - CURRENTGOOD MANUFACTURINGPRACTICE IN MANUFACTURING,PACKAGING, LABELING, ORHOLDING OPERATIONS FORDIETARY SUPPLEMENTSSubpart G--Productionand Process Control System:Requirements for Components,Packaging, and Labels and forProduct That You Receive forPackaging or Labeling as aDietary Supplement§ 111.153 - What are therequirements under this subpart Gfor written procedures?§ 111.155 - What requirementsapply to components of dietarysupplements?§ 111.160 - What requirementsapply to packaging and labelsreceived?§ 111.165 - What requirementsapply to a product received forpackaging or labeling as a dietarysupplement (and for distributionrather than for return to thesupplier)?§ 111.170 - What requirementsapply to rejected components,packaging, and labels, and torejected products that are receivedfor packaging or labeling as adietary supplement?§ 111.180 - Under this subpart G,what records must you make andkeep?Subpart H--Productionand Process Control System:Requirements for the MasterManufacturing Record§ 111.205 - What is therequirement to establish a mastermanufacturing record?§ 111.210 - What must the mastermanufacturing record include?Subpart I--Productionand Process Control System:Requirements for the BatchProduction Record§ 111.255 - What is therequirement to establish a batchproduction record?§ 111.260 - What must the batchrecord include?Part 210, Part 211 CURRENT GOODMANUFACTURINGPRACTICE FOR FINISHEDPHARMACEUTICALSPart 820 - QUALITY SYSTEMREGULATIONSubpart J--Records andReportsSubpart M--Records§ 820.181 - Device master record.§ 211.186 - Masterproduction and controlrecords.Subpart J--Records andReports§ 211.188 - Batchproduction and controlrecords.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSPart 110 - CURRENTGOOD MANUFACTURINGPRACTICE INMANUFACTURING,PACKING, OR HOLDINGHUMAN FOODPart 111 - CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKAGING,LABELING, OR HOLDINGOPERATIONS FOR DIETARYSUPPLEMENTSPart 210, Part 211 - CURRENTGOOD MANUFACTURINGPRACTICE FOR FINISHEDPHARMACEUTICALSPart 820 - QUALITY SYSTEMREGULATIONProduction ProcessLaboratoryOperationsSubpart J--Production and ProcessControl System: Requirements forLaboratory Operations§ 111.303 - What are the requirementsunder this subpart J for writtenprocedures?§ 111.310 - What are the requirementsfor the laboratory facilities that you use?§ 111.315 - What are the requirementsfor laboratory control processes?§ 111.320 - What requirements apply tolaboratory methods for testing andexamination?§ 111.325 - Under this subpart J, whatrecords must you make and keep?Subpart I--Laboratory Controls§ 211.160 - Generalrequirements.§ 211.165 - Testing and releasefor distribution.§ 211.166 - Stability testing.§ 211.167 - Special testingrequirements.§ 211.170 - Reserve samples.§ 211.173 - Laboratory animals.§ 211.176 - Penicillincontamination.Production ProcessControls –ManufacturingOperationsSubpart K--Production and ProcessControl System: Requirements forManufacturing Operations§ 111.353 - What are the requirementsunder this subpart K for writtenprocedures?§ 111.355 - What are the designrequirements for manufacturingoperations?§ 111.360 - What are the requirementsfor sanitation?§ 111.365 - What precautions must youtake to prevent contamination?§ 111.370 - What requirements apply torejected dietary supplements?§ 111.375 - Under this subpart K, whatrecords must you make and keep?Subpart F--Production andProcess Controls§ 211.100 - Writtenprocedures; deviations.§ 211.101 - Charge-in ofcomponents.§ 211.103 - Calculation ofyield.§ 211.105 - Equipmentidentification.§ 211.110 - Sampling andtesting of in-process materialsand drug products.§ 211.111 - Time limitationson production.§ 211.113 - Control ofmicrobiological contamination.§ 211.115 - Reprocessing.Subpart G--Production and ProcessControls§ 820.70 - Production and processcontrols.§ 820.72 - Inspection, measuring,and test equipment.§ 820.75 - Process validation.Production ProcessControl – Packagingand LabelingOperationsSubpart L--Production and ProcessControl System: Requirements forPackaging and Labeling Operations§ 111.403 - What are the requirementsunder this subpart L for writtenprocedures?§ 111.410 - What requirements apply topackaging and labels?§ 111.415 - What requirements apply tofilling, assembling, packaging, labeling,and related operations?§ 111.420 - What requirements apply torepackaging and relabeling?§ 111.425 - What requirements apply toa packaged and labeled dietarysupplement that is rejected fordistribution?§ 111.430 - Under this subpart L, whatrecords must you make and keep?Subpart G--Packaging andLabeling Control§ 211.122 - Materials examinationand usage criteria.§ 211.125 - Labeling issuance.§ 211.130 - Packaging andlabeling operations.§ 211.132 - Tamper-evidentpackaging requirements for overthe-counter (OTC) human drugproducts.§ 211.134 - Drug productinspection.§ 211.137 - Expiration dating.Subpart K--Labeling and PackagingControl§ 820.120 - Device labeling.§ 820.130 - Device packaging.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSPart 110 - CURRENTPart 111 - CURRENT GOOD MANUFACTURINGGOODPRACTICE IN MANUFACTURING, PACKAGING,MANUFACTURINGLABELING, OR HOLDING OPERATIONS FORPRACTICE INDIETARY SUPPLEMENTSMANUFACTURING,PACKING, OR HOLDINGHUMAN FOODPart 210, Part 211 - CURRENTGOOD MANUFACTURINGPRACTICE FOR FINISHEDPHARMACEUTICALSPart 820 - QUALITY SYSTEM REGULATIONHolding andDistributionSubpart E-Production andProcess Controls§ 111.93 –Warehousing andDistributionSubpart M--Holding and Distributing§ 111.453 - What are the requirementsunder this subpart for M writtenprocedures?§ 111.455 - What requirements apply toholding components, dietary supplements,packaging, and labels?§ 111.460 - What requirements apply toholding in-process material?§ 111.465 - What requirements apply toholding reserve samples of dietarysupplements?§ 111.470 - What requirements apply todistributing dietary supplements?§ 111.475 - Under this subpart M, whatrecords must you make and keep?Subpart H--Holding andDistribution§ 211.142 - Warehousingprocedures.§ 211.150 - Distributionprocedures.Subpart L--Handling, Storage,Distribution, and Installation§ 820.140 - Handling.§ 820.150 - Storage.§ 820.160 - Distribution.§ 820.170 - Installation.Returned andSalvaged ProductsSubpart N--Returned DietarySupplements§ 111.503 - What are the requirementsunder this subpart N for writtenprocedures?§ 111.510 - What requirements applywhen a returned dietary supplement isreceived?§ 111.515 - When must a returneddietary supplement be destroyed, orotherwise suitably disposed of?§ 111.520 - When may a returneddietary supplement be salvaged?§ 111.525 - What requirements apply toa returned dietary supplement that qualitycontrol personnel approve forreprocessing?§ 111.530 - When must an investigationbe conducted of your manufacturingprocesses and other batches?§ 111.535 - Under this subpart N, whatrecords must you make and keep?Subpart K--Returned andSalvaged Drug Products§ 211.204 - Returned drugproducts.§ 211.208 - Drug productsalvaging.Product ComplaintsSubpart O--Product Complaints§ 111.553 - What are the requirementsunder this subpart O for writtenprocedures?§ 111.560 - What requirements apply tothe review and investigation of a productcomplaint?§ 111.570 - Under this subpart O, whatrecords must you make and keep?Subpart J--Records andReports§ 211.198 - Complaint files.Subpart M--Records§ 820.198 - Complaint files.
Side-by-Side Comparison – 21 CFR, Parts 110, 111, 211 and 820REGULATIONSPart 110 - CURRENTGOODMANUFACTURINGPRACTICE INMANUFACTURING,PACKING, ORHOLDING HUMANFOODRecords, Reports,and recordkeepingPresented by:Dean CirottaPresident and CEOEAS Consulting Group, LLC1700 Diagonal RoadSuite 750Alexandria, VA 22314571-447-5502Part 111 - CURRENT GOODMANUFACTURING PRACTICE INMANUFACTURING, PACKAGING,LABELING, OR HOLDINGOPERATIONS FOR DIETARYSUPPLEMENTSPart 210, Part 211 CURRENT GOODMANUFACTURINGPRACTICE FOR FINISHEDPHARMACEUTICALSPart 820 - QUALITY SYSTEMREGULATIONSubpart P--Records andRecordkeeping§ 111.605 - What requirementsapply to the records that you makeand keep?§ 111.610 - What records must bemade available to FDA?Subpart J--Records andReports§ 211.180 - Generalrequirements.§ 211.182 - Equipmentcleaning and use log.§ 211.184 - Component,drug product container,closure, and labeling records.§ 211.186 - Masterproduction and controlrecords.§ 211.188 - Batchproduction and controlrecords.§ 211.192 - Productionrecord review.§ 211.194 - Laboratoryrecords.§ 211.196 - Distributionrecords.Subpart M--Records§ 820.180 - General requirements.§ 820.181 - Device master record.§ 820.184 - Device history record.§ 820.186 - Quality system record.
side-by-side comparison – 21 cfr, parts 110, 111, 211 and 820 regulations part 110 - current good manufacturing practice in manufacturing, packing, or holding human food part 111 - current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for die
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