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