Quality management systems for medical, pharmaceutical,
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The document discusses quality management systems (QMS) for medical, pharmaceutical, cosmetic, and food products, highlighting their regulatory requirements in Europe and the USA and comparing them to ERP systems. It details the necessity of good practices (GxP), record keeping, and the integration of QMS with ERP for effective quality control and compliance. The document emphasizes risk management and the operational impact of adhering to both QMS and ERP systems in maintaining product quality and safety.
![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]”](https://image.slidesharecdn.com/qualitymanagementsystemsformedicalpharmaceutical-130429032954-phpapp01/85/Quality-management-systems-for-medical-pharmaceutical-3-320.jpg)
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Quality management systems for medical, pharmaceutical,
- 1. Quality Management Systems for Medical, Pharmaceutical, Cosmetic and Food Products And their differences with ERP Systems
- 2. Background Requirements for Quality Management Systems
- 3. 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]”
- 4. 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
- 5. 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
- 6. 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
- 7. 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…”
- 8. 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
- 9. GAMP 5, ICH Q9 “Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment”
- 11. 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
- 12. 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
- 13. 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
- 14. 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
- 15. Protection Protection of records to ensure their accurate and ready retrieval throughout the records retention period
- 16. 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
- 17. Audit Trail Secure, computer generated timestamped audit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records
- 18. 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
- 19. ERP ERP Functions ◦ General Ledger ◦ Purchasing ◦ Inventory ◦ Sales ◦ Accounts Receivables ◦ Accounts Payables ◦ Production Planning & Control Logistics Production Schedule Job Costing ◦ etc
- 20. 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, training needs, 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
- 21. 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
- 23. Governance, Risk and Compliance
- 25. Environment, Health and Safety
- 27. QMS and ERP Integration
- 29. Integration Points – Core Module Personnel – staff/user id, departments, teams, positions, roles Business Units, Organization Units Business Calendar
- 30. 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
- 31. 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)
- 32. 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
- 33. Integration Points - Inventory Inventory types, inventory item ID, storage locations Supplier names and details Shippers names and details
- 34. Acquisition Planning Fized Assets Acquisitions Delivery/ Installation Operations/ Maintenance Process Integration – Fixed Assets QMS 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
- 35. Integration Points – Fixed Assets Equipment ID and details Supplier ID and details Maintenance service providers ID and details Maintenance/ calibration records and schedules
- 37. 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