Quality Management Systems for Medical,
Pharmaceutical, Cosmetic and Food Products
And their differences with ERP Systems
BackgroundRequirements for Quality Management Systems
Regulations and Regulators
Europe – Directive 2003/94/EC (EU Regulators)◦ GMP: “the part of quality assurance which ensures
that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use”
USA – F,D&C Act, Federal Codes (FDA)◦ “… the minimum current good manufacturing
practice for … the manufacture, processing, packing, or holding of a drug to assure [safety, identity, strength, quality and purity]”
The GxP’s
“Good x Practice”◦ Good Clinical Practice
◦ Good Distribution Practice
◦ Good Laboratory Practice
◦ Good Manufacturing Practice
GxP Controls to are required to minimize risks to◦ Patient Safety
◦ Product Quality
◦ Data Integrity
Objective
“Our primary focus will remain the same: to minimize the risks to the public health”
- Department of Health and Human Services, U.S. Food and Drug Administration
Laws, Regulations and Guidance
Law, e.g.◦ Food, Drug & Cosmetic Act, EU Directive
Regulations, e.g.◦ 21 CFR 211, 21 CFR 820, EU GMPs
Guidance, e.g.◦ FDA Guidance on Part 11 Scope and Application
The Food, Drug and Cosmetic Act
“A drug or device shall be deemed to be adulterated … if it is a drug and the methods used in, or the facilities or controls and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drugs meet the requirements of this chapter as to safety and has the identity and strength, and meet the quality and purity characteristics, which it purports or is represented to possess…”
21 CFR 211.68 Automatic, Mechanical and Electronic Equipment
Must◦ Perform a function satisfactorily
◦ Calibrated, inspected or checked according to a written programme
◦ Controlled in use
◦ The data is secure
◦ Outputs are accurate
◦ Adequately backed up, maintained and documented
◦ Under change control
GAMP 5, ICH Q9
“Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment”
Quality Management Systems
Records and Signatures
Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format
Records that are required to be maintained under predicate rules that are maintained in electronic format in addition to paper format, and that are relied upon to perform regulated activities
Records submitted to FDA under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format.
◦ - FDA Scope and Application Guidance
Elecronic Record
Electronic record means any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system
Electronic Signature
Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature
Validation of Systems
Validation of systems to ensure accuracy, reliability, consistent intended performance and the reliability to discern invalid or altered records
This clause is currently under enforcement discretion
Protection
Protection of records to ensure their accurate and ready retrieval throughout the records retention period
Record Retention
Must meet predicate rule requirements and preserve content and meaning
Decision how should be based on predicate requirements, a justified and documented risk assessment, and determination of the value of the records over time
Audit Trail
Secure, computer generated timestampedaudit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records
Quality Management System
Quality Modules• Risk Management• Document Management• Project Management• Process Management• IT Services Management• Product Life Cycle Mgt• Competency
Management• Asset Management• Preventive/Corrective
Actions• etc
ERP
ERP Functions◦ General Ledger
◦ Purchasing
◦ Inventory
◦ Sales
◦ Accounts Receivables
◦ Accounts Payables
◦ Production Planning & Control Logistics
Production Schedule
Job Costing
◦ etc
Differences
Quality Management Systems ERP Systems
Data related to Quality Management• Quality documents, policies, SOP,
procedures, checklist• Project plans eg product lifecycle
management activities: prepare specs, drawings, acceptance, tooling, training
• Quality related workflows• Preventive/ corrective actions:
equipment maintenance, customer complaints, incoming QC
• Risk management – identification, quantification, control plan, monitoring
• Quality related KPIs – reworks, downtime, deadlines
• Staff training – evaluation, trainingneeds, scheduling, certification
Financial, manufacturing and logistic data• Order entry, deliveries, sales invoicing,
accounts receivables• Purchase requisitions, purchase orders,
deliveries, accounts payables• Cash and payment management, bank
reconciliation, cashflow reporting• Manufacturing plans, production
scheduling• Inventory management, receipts,
issuance, stock levels, transfers• Facility management, fixed asset
register, acquisitions, disposals, depreciation
• Human resource management, payroll, taxes
Comparison of ERP to Quality Management System
Quality Management Systems complement ERP Systems
Quality Management Systems manages quality documents, processes, people, facilities and assets, materials
ERP systems manages accounting and logistics aspects of finance, production, inventories
Enterprise Quality Management
Governance, Risk and Compliance
Enterprise Risk Management
Environment, Health and Safety
Document Management
QMS and ERP Integration
Integrated Solution Architecture
Data Synchronization
with ERPIntegration
Integration Points – Core Module
Personnel – staff/user id, departments, teams, positions, roles
Business Units, Organization Units
Business Calendar
Process Integration – Sales/ Production
Predefined Parts
Custom Order
Production
Sales Support
QMS ERP
• Specifications Docs• Drawings
• Project Planning• Specifications/
Drawings – Revision Control/ Acceptance
• Commercial Proposal Docs
• Change Management
• Quality Records• Quality KPIs• Process Risks
• Logistics Document Capture/ Storage
• Corrective Actions
• Parts Definitions• Parts Details/ Std
Costs
• Sales Quotation• Order Entry• Subcontractors
Quotations• Credit Control
• Production Planning/ Control
• Inventory• Cost Accounting
• Delivery Order• Invoicing• Accounts Receivables
Integration Points - Production
Item types Part numbers Part details eg descriptive details, alias
names Equipment ID Process/ Run / Batch ID and details Customer names and details Subcontractor names and details (if
applicable)
Item Definitions
Purchase Order
Delivery
Inventory Management
Process Integration – Purchasing/ Inventory
QMS ERP
• Specifications Docs• Drawings
• Document Management
• Request Documents
• Suppliers Proposals
• Change Management
• Delivery Documents• Incoming Inspections
• Quality Checks (Expiry/ Deteriorations)
• Parts Definitions• Parts Details/ Std
Costs
• Supplier Quotation• Purchase Order Entry• Delivery Tracking
• Inventory Receiving• Supplier Invoices• Accounts Payables
• Inventory Records• Stock Taking• Stock Movements
Integration Points - Inventory
Inventory types, inventory item ID, storage locations
Supplier names and details
Shippers names and details
Acquisition Planning
Fized Assets Acquisitions
Delivery/ Installation
Operations/ Maintenance
Process Integration – Fixed AssetsQMS ERP
• Specifications Docs• Drawings• Budgetary
Documents• Change Management
• Tender Documents• Contract Documents
• Delivery Documents• Incoming Inspections• Test/ Commissioning
Reports• Correctuve Actions
• Calibration• Preventive/
Corrective Maintenance
• Parts Definitions• Parts Details/ Std
Costs
• Supplier Quotation• Purchase Order Entry• Delivery Tracking
• Inventory Receiving• Supplier Invoices• Accounts Payables
• Inventory Records• Stock Taking• Stock Movements
Integration Points – Fixed Assets
Equipment ID and details
Supplier ID and details
Maintenance service providers ID and details
Maintenance/ calibration records and schedules
ConclusionAnd Benefits
Impact of Quality Management Systems
•US FDA Regulations
•EU Directives
•GMP Requirements
•Other Legal and Regulatory RequirementsCompliance
•Available When Neeeded
•Secured Access
•Document Loss/ Tampering
•Non-RepudiationEffectiveness
•Loss of Business/ Opportunities
•Inability to Access Market
•Inability to Enforce Contracts & Agreements
•Inability to Defend Against Litigations & Suits
Risk Management
•Search & Retrieval
•< 10 mins 75%
•< 1 hour 25%
•Sharing/ Alert
•Storage Utilization
Efficiency