Post on 08-Jun-2020
ISO 9001 and 21 CFR 210 211ISO 9001 and 21 CFR 210 211““Working Together for QualityWorking Together for Quality””
Theresa McCarthy Theresa McCarthy 18 January 201118 January 2011
Agenda
What Requirements in ISO 9001:2008What Requirements in ISO 9001:2008can be used to enhance your existing can be used to enhance your existing cGMP cGMP quality system?quality system?
If you are ISO 9001:2008 registered what If you are ISO 9001:2008 registered what additional requirements are needed to additional requirements are needed to management comply with 21 CFR 210?management comply with 21 CFR 210?
Agenda
Background Information on StandardsBackground Information on Standards
ISO 9001:2008ISO 9001:2008
Voluntary StandardVoluntary Standard
FDA Quality SystemsFDA Quality Systems
LawLaw
Guidance Documents AvailableGuidance Documents Available
Discuss Additional RequirementsDiscuss Additional Requirements
Companies Here Today??
Medical DeviceMedical Device
21 CFR 82021 CFR 820
ISO 13485:ISO 13485:
Biotech/PharmaBiotech/Pharma
21 CFR 210, 21121 CFR 210, 211
ICH Q7ICH Q7
Other????Other????
Quality Management Systems
ISO 9001 first published 1987ISO 9001 first published 1987
ThenThen……..1994 ..1994
ISO 9001: 2000 ISO 9001: 2000 Technical RevisionTechnical Revision
15 November 2008 is an Amendment15 November 2008 is an Amendment--
Clarify points in the text Clarify points in the text
Enhance compatibility with ISO 14001:2004Enhance compatibility with ISO 14001:2004
700,000 worldwide certified700,000 worldwide certified
50,000 North America certified50,000 North America certified
ISO Quality Management System
QualityQuality ManualManualQuality Quality
ProceduresProcedures
Work InstructionsWork Instructions
Records Records
Management Review
Corrective andPreventive Action
Internal Audit
ISO 9001 Quality Management System
Customers Customers
Requirements
Satisfaction
Management Responsibility
Product Realization
Measurement, analysis and improvement
Productinput output
Resource Management
ISO 9001:2008
No legal requirement to comply with cGMPNo legal requirement to comply with cGMP
Voluntary StandardVoluntary Standard
RegisteredRegistered
Minimize Customer AuditsMinimize Customer Audits
UnlessUnless…………Device Companies Device Companies –– EuropeEurope
Technical FileTechnical File
CE Marking???CE Marking???
ISO 9001
4.04.0 Quality SystemQuality System
5.05.0 Management ResponsibilityManagement Responsibility
6.06.0 ResourcesResources
7.07.0 Product RealizationProduct Realization
8.08.0 Measurement, Analysis and Measurement, Analysis and ImprovementImprovement
NoteNote:: Configuration ManagementConfiguration ManagementAS9100, ISO13485, ISO14000, IPEC AS9100, ISO13485, ISO14000, IPEC ––GMP GuideGMP Guide
ISO Eyesoh=EqualISO Eyesoh=Equal
FDA Drug Mfg Inspection Systems
LaboratoryControl
SystemsProductionSystem
Packaging & Labeling
System Material System
QualitySystem
Facilities &Equipment
SystemMANAGEMENT
cGood Manufacturing Practices
Legally Required to comply with cGMPLegally Required to comply with cGMP
Regulations Enforceable by LawRegulations Enforceable by Law
Enforced by the FDAEnforced by the FDA
Register with FDA annuallyRegister with FDA annually
FDA
When publishing the Guidance for Industry "Quality When publishing the Guidance for Industry "Quality System Approach to Pharmaceutical cGMP" on 29 System Approach to Pharmaceutical cGMP" on 29 September 2004, the FDA took requirements from the ISO September 2004, the FDA took requirements from the ISO 9001 document on "Quality Management Systems" into 9001 document on "Quality Management Systems" into account in the field of pharmaceutical manufacture account in the field of pharmaceutical manufacture
Guide on Quality Systems ModelGuide on Quality Systems Model
Management ResponsibilitiesManagement Responsibilities
ResourcesResources
Manufacturing OperationsManufacturing Operations
Evaluation ActivitiesEvaluation Activities
ICH Q 10
International Council on HarmonizationInternational Council on Harmonization
““Pharmaceutical Quality SystemsPharmaceutical Quality Systems””
Guidance Model for Implementing Effective Quality Guidance Model for Implementing Effective Quality Management SystemManagement System
Harmonization EffortHarmonization Effort
European UnionEuropean Union
JapanJapan
United StatesUnited States
Augment Rather than Replace Current RegulationsAugment Rather than Replace Current Regulations
Harmonize with the Regional GuidanceHarmonize with the Regional Guidance
ICH Q7ICH Q7
CGMP More Detailed Validation Requirements
EquipmentEquipment
Facilities Facilities
Methods Methods
CleaningCleaning
SoftwareSoftware
Electronic SystemsElectronic Systems
21 CFR Part 1121 CFR Part 11
ISO 9001 Process Based
Identify ProcessesIdentify Processes CoreCore SupportSupport
ProcessProcess
Input Input
OutputOutput
PhasesPhases
Gates/ReviewsGates/Reviews
CC22 QQ
M&MM&M
ISO 9001 Control of Documents
While reviewing Records in ISO 9001:2008 SystemWhile reviewing Records in ISO 9001:2008 System
cGMP Documentation PracticescGMP Documentation Practices
Are there complete mfg instructionsAre there complete mfg instructions
Raw MaterialRaw Material
EquipmentEquipment
Steps: Performed By: Steps: Performed By: Verified By:Verified By:
Documents that impact product quality reviewed Documents that impact product quality reviewed by and approved by Quality (independent)by and approved by Quality (independent)
Operating ParametersOperating Parameters•• (more than 6 SOPs required)(more than 6 SOPs required)
Adding ISO 9001 to a GMP System
Develop a Quality ManualDevelop a Quality Manual
Develop a Quality PolicyDevelop a Quality Policy
CommunicateCommunicate
How do you Contribute?How do you Contribute?
Continually Continually Improve Improve the Effectiveness of the the Effectiveness of the QMSQMS
ISO 13485ISO 13485-- Maintain Maintain
Customer Focus
ISO ISO –– How are customer requirements determined How are customer requirements determined and translated into the Quality System?and translated into the Quality System?
GMPGMP-- S I S P QS I S P Q
Safety Safety
IdentityIdentity
StrengthStrength
PurityPurity
QualityQuality
Planning
Top Management shall ensure that Quality Top Management shall ensure that Quality Objectives are establishedObjectives are established
Product Product
ProcessesProcesses
Responsibility and Authority
GMP GMP
Quality Unit??? Quality Unit??? –– Independent Reporting Independent Reporting Relationship Between Production and Relationship Between Production and Quality Unit. Quality Unit.
Management Responsibility
ISOISO Management RepresentativeManagement Representative
AppointedAppointed
Establish ProcessesEstablish Processes
ReportReport
Promote awareness of Customer RequirementsPromote awareness of Customer Requirements
Management Review
Review InputReview Input
AuditsAudits
Customer FeedbackCustomer Feedback
Process Performance and Product Process Performance and Product ConformityConformity
Status of Preventive and Corrective Status of Preventive and Corrective ActionAction
Follow UpFollow Up
Changes that could affect qmsChanges that could affect qms
Recommendation for ImprovingRecommendation for Improving
Note: 13485Note: 13485------Regulatory Regulatory RequirementsRequirements
Notes: Notes: Quality CouncilQuality Council–– Annual Product Annual Product
Review?? APRReview?? APR0
102030405060708090
1stQtr
2ndQtr
3rdQtr
4thQtr
EastWestNorth
cGMP Resources Needed in ISO 9001
Section 6.0 ISO Standard Resource ManagementSection 6.0 ISO Standard Resource Management
6.1 Provision of Resources6.1 Provision of Resources
6.2 Human Resources6.2 Human Resources
Competence, Awareness and TrainingCompetence, Awareness and Training•• GMP training should be sufficient frequency to GMP training should be sufficient frequency to
ensure employees remain familiar with GMP.ensure employees remain familiar with GMP.
Personal HygienePersonal Hygiene
6.3 Infrastructure6.3 Infrastructure
Buildings and FacilitiesBuildings and Facilities
Equipment Equipment -- CommissioningCommissioning•• Construction Construction –– Contact SurfacesContact Surfaces•• Maintenance Maintenance -- SOPSOP•• Computer Systems Computer Systems –– Access controls backupAccess controls backup•• Utilities Utilities –– risk of contaminationrisk of contamination•• Water Water ––treatment and monitoringtreatment and monitoring
cGMP Resources Needed in ISO 9001
6.4 6.4 Work Environment Work Environment –– shall determine shall determine and manage environment needed to achieve conformity to and manage environment needed to achieve conformity to product.product.
Air Handling Air Handling –– RecirculationRecirculation
Controlled Environment Controlled Environment -- MonitoringMonitoring
Cleaning and Sanitary Conditions Cleaning and Sanitary Conditions –– Schedules, WasteSchedules, Waste
Pest Control Pest Control –– Free of Infestation, Contractor RecordsFree of Infestation, Contractor Records
Lighting Lighting -- AdequateAdequate
Drainage Drainage -- AdequateAdequate
Washing and Toilet FacilitiesWashing and Toilet Facilities
7.0 Product Realization GMP Needs
Planning of Product RealizationPlanning of Product Realization
Customer Related ProcessesCustomer Related Processes
Customer CommunicationCustomer Communication
Design and Development Design and Development –– (defined point at which GMP (defined point at which GMP applies in Mfg)applies in Mfg)
PurchasingPurchasing
Supply Chain Approach ChangingSupply Chain Approach Changing
Quality AgreementsQuality Agreements
HeparinHeparin
BSE TSE BSE TSE
7.0 Product Realization GMP Needs
Customer PropertyCustomer Property
Chain of CustodyChain of Custody
Preservation of ProductPreservation of Product
HSPPD HSPPD ––
Temperature Mapping Warehouse Temperature Mapping Warehouse
Pallets Pallets •• ISO 9001??? ISO 9001???
7.6 Calibration
Out of ToleranceOut of Tolerance——OOTOOT
Actions taken if found to be beyondActions taken if found to be beyond
How is system documented?How is system documented?
Is there an SOP in ISO9001 or are Is there an SOP in ISO9001 or are Records required of the results?Records required of the results?
8.0 Measurement Analysis and Improvement
M & M ProcessesM & M Processes
Demonstrate conformity to Demonstrate conformity to productproduct
9001 and GMP9001 and GMP
Customer SatisfactionCustomer Satisfaction
““Customer Perception:Customer Perception:
Methods for Obtaining Feedback Methods for Obtaining Feedback
8.0 Measurement Analysis and Improvement
Analysis of DataAnalysis of Data
Demonstrate Suitability and Demonstrate Suitability and EffectivenessEffectiveness of of QMSQMS
Customer SatisfactionCustomer Satisfaction
Conformity to Product RequirementsConformity to Product Requirements
Characteristics and Trends of Processes and Characteristics and Trends of Processes and ProductsProducts
•• Opportunities for Preventive ActionOpportunities for Preventive Action
SuppliersSuppliers
8.2.2. Internal Audits
Does 21 CFR 210, 211 call for Internal Does 21 CFR 210, 211 call for Internal Audits?Audits?
Laboratory Controls M&M of Product
Procedures and RecordsProcedures and Records
Out of Specification Test ResultsOut of Specification Test Results
Retained SamplesRetained Samples
Certificates of AnalysisCertificates of Analysis
Impurities Impurities –– Residual SolventsResidual Solvents
Stability Stability
8.0 Measurement Analysis and Improvement
Continual ImprovementContinual Improvement
Corrective ActionCorrective Action
Prevent Prevent ReRecurrencecurrence
Preventive ActionPreventive Action
Prevent Prevent OccurrenceOccurrence
Working Together for Quality
YesYes…….Both Systems Need.Both Systems Need
ManpowerManpower
MethodsMethods
MeasurementsMeasurements
MaterialsMaterials
MachinesMachines•• Money?Money?
Summary
ISO9001ISO9001
Create Quality Control Unit with More Create Quality Control Unit with More Responsibility and Authority than a Responsibility and Authority than a Management Representative Management Representative
Create required systems and procedures Create required systems and procedures required by GMPrequired by GMP--Product SpecificProduct Specific
Trained and Aware of Legal Trained and Aware of Legal Responsibilities inherent in GMPResponsibilities inherent in GMP
Summary
GMP need to DevelopGMP need to Develop
Metrics and Procedures for Measuring Metrics and Procedures for Measuring the Effectiveness of QMSthe Effectiveness of QMS
Management Review ProgramManagement Review Program
Program for Capturing Customer Program for Capturing Customer Satisfaction DataSatisfaction Data
Thank You for Your Participation
Theresa.McCarthy@comcast.netTheresa.McCarthy@comcast.net
Note: Boscon Conference Note: Boscon Conference
Waltham WoodsWaltham Woods
April 11, 12April 11, 12•• Asqboston.orgAsqboston.org