Pharmaceuticals and Life Sciences Solutions
Introduction
Pharmaceutical and life sciences companies operate under the most stringent regulatory oversight in any industry. FDA regulations for Current Good Manufacturing Practice (cGMP), 21 CFR Part 11 electronic records, drug supply chain security, clinical trial protocols, pharmacovigilance requirements, serialization mandates under the Drug Supply Chain Security Act (DSCSA), and quality management system standards demand comprehensive automated validation.
Pharmaceutical industry-specific challenges include batch record integrity, material traceability from API through finished dosage, environmental monitoring and deviation management, equipment qualification and calibration, change control procedures, complaint handling and adverse event reporting, validation documentation, supplier qualification, stability testing protocols, and regulatory submission preparation.
QUALIA Rule Engine enables pharmaceutical companies to automate cGMP compliance and quality system validations while maintaining product safety and regulatory adherence.
Pharmaceutical industry validation requirements:
Batch record completeness and electronic signature compliance
Material traceability and chain of custody documentation
Deviation management and CAPA (Corrective and Preventive Action)
Change control approval workflows
Equipment calibration and qualification status
Supplier qualification and audit scheduling
Complaint investigation and adverse event reporting
Product serialization and aggregation per DSCSA
Part 1: Batch Record Integrity and 21 CFR Part 11
Electronic Batch Record Validation
FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures.
Validation Set: Batch Record - Completeness Check - OnRelease
Rule 1: Enforce Batch Record Completeness
Table: Production Order (5405)
Source References:
1. Item (27) - Finished drug product
Link via: [5405:11] = [27:1]
2. Batch Record Step (Custom Table)
Link via: [5405:1] = [BatchStep:ProductionOrderNo]
3. Routing (99000763)
Link via: [5405:Route] = [Routing:No]
Condition:
[27:CustomPharmaceuticalProduct] is true
AND EXISTS(BatchStep WHERE [Completed] is false OR [VerifiedBy] is '')
AND [5405:Status]
Action - Message:
Type: Error
Message:
BATCH RECORD INCOMPLETE - cGMP VIOLATION
Batch Number: [5405:1]
Product: [27:3]
Batch Size: [5405:8]
Scheduled Start: [5405:StartingDate]
FDA 21 CFR 211.188 - BATCH PRODUCTION AND CONTROL RECORDS:
All batch records must be complete, verified, and approved before batch release.
Incomplete Batch Steps:
[FOR EACH BatchStep WHERE Completed is false OR VerifiedBy is '':
Step: [BatchStep:OperationNo] - [BatchStep:Description]
Status: [IF(NOT Completed, '❌ NOT COMPLETED', IF(VerifiedBy is '', '❌ NOT VERIFIED', ''))]
Performed By: [BatchStep:PerformedBy]
Performed Date: [BatchStep:PerformedDate]
Verified By: [BatchStep:VerifiedBy]
Verified Date: [BatchStep:VerifiedDate]
]
cGMP Batch Record Requirements:
☐ All manufacturing steps completed and documented
☐ Actual yields recorded at appropriate phases
☐ In-process controls performed and results recorded
☐ Deviations documented with investigation
☐ Each step verified by second person (dual verification)
☐ Equipment identification documented
☐ Material lot numbers recorded
☐ Environmental conditions monitored
☐ Batch review completed
☐ Quality assurance approval obtained
21 CFR Part 11 Electronic Signature Requirements:
• Electronic signatures must be linked to records
• Signatures must include printed name, date, and meaning (e.g., "Performed", "Verified", "Approved")
• Records must be human-readable
• Audit trail must capture all record changes
Each batch step requires:
1. Performance by qualified operator
2. Electronic signature with timestamp
3. Independent verification by second qualified person
4. Electronic signature by verifier
5. Deviation documentation if applicable
Incomplete Documentation Consequences:
- Batch cannot be released for distribution
- FDA Form 483 observation
- Warning letter for repeat violations
- Consent decree for serious violations
- Product recall if distributed without complete records
- Criminal prosecution for falsification
Complete all batch steps and obtain required verifications before batch release.
Batch Record System: [Link to MES/LIMS]
Quality Assurance: [Contact]
Rule 2: Enforce Dual Verification
Validation Set: Batch Step - Dual Verification - OnComplete
Table: Batch Record Step (Custom Table)
Condition:
[BatchStep:CriticalStep] is true
AND [BatchStep:PerformedBy] = [BatchStep:VerifiedBy]
Action - Message:
Type: Error
Message:
DUAL VERIFICATION REQUIRED - INDEPENDENT VERIFICATION
Batch: [BatchStep:ProductionOrderNo]
Step: [BatchStep:OperationNo] - [BatchStep:Description]
Critical Step: YES
Performed By: [BatchStep:PerformedBy]
Attempted Verification By: [BatchStep:VerifiedBy]
⚠️ VERIFICATION FAILURE: Self-verification not permitted
cGMP DUAL VERIFICATION REQUIREMENT:
Critical manufacturing steps require independent verification by second qualified person.
Critical Steps Requiring Dual Verification:
• Dispensing of active pharmaceutical ingredient (API)
• Addition of potent materials
• In-process weight checks
• Cleaning verification
• Equipment setup and line clearance
• Label reconciliation
• Sampling
• Transfer between production areas
• Final product release testing
Independent Verification Means:
- Different person than who performed the step
- Qualified and trained on the procedure
- Contemporaneous verification (at time of activity)
- Not subordinate to person who performed step (when practical)
Purpose of Dual Verification:
Reduce risk of human error by having second person verify:
✓ Correct material
✓ Correct quantity
✓ Correct equipment
✓ Procedure followed correctly
✓ Documentation complete
Verification Process:
1. Operator performs critical step and documents
2. Operator signs electronically (with meaning: "Performed")
3. Operator requests independent verification
4. Second qualified person observes or verifies results
5. Verifier signs electronically (with meaning: "Verified")
6. Both signatures timestamped and captured in audit trail
Select different person for independent verification.
Available Verifiers: [List of qualified personnel on shift]
Part 2: Material Traceability and Chain of Custody
API and Excipient Traceability
Complete material genealogy is required for pharmaceutical products.
Validation Set: Production - Material Traceability - OnPost
Rule 1: Enforce Lot Genealogy Capture
Source References:
1. Item Ledger Entry (32) - Material consumption
Link via: [ProdOrder:No] = [32:OrderNo]
Reference Filters:
[32:7] is 'Consumption'
2. Material Lot (Custom Table)
Link via: [32:CustomLotNo] = [MatLot:LotNo]
Condition:
[Item:CustomAPIorExcipient] is true
AND [32:CustomLotNo]
Action - Message:
Type: Error
Message:
LOT NUMBER REQUIRED FOR MATERIAL TRACEABILITY
Production Order: [ProdOrder:No]
Finished Product: [ProdOrder:Item:Description]
Batch Number: [ProdOrder:No]
Material Consumed:
Item: [Item:Description]
Material Type: [Item:CustomMaterialType]
Quantity: [32:Quantity] [32:UOM]
Supplier: [If purchased, Vendor:Name]
FDA 21 CFR 211.188(b)(11):
Batch production records must include identification and individual weights or measures of each component used.
Material Traceability Requirements:
Every pharmaceutical material must have:
• Unique lot number
• Receipt date and receiving report number
• Identity testing results
• QA release status
• COA (Certificate of Analysis) from supplier
• Storage conditions
• Expiration or retest date
Lot Genealogy Purpose:
Links raw materials through batch to finished product enabling:
1. FORWARD TRACEABILITY: Which finished product batches contain this material lot?
2. BACKWARD TRACEABILITY: Which material lots were used in this finished batch?
3. RECALL SCOPE: Identify all affected batches if material issue discovered
4. INVESTIGATION: Root cause analysis for quality issues
5. REGULATORY INSPECTION: Demonstrate chain of custody
Critical Material Tracking:
API (Active Pharmaceutical Ingredient):
- COA from API manufacturer
- Potency and purity results
- Synthesis batch number
- DMF (Drug Master File) reference
Excipients:
- Supplier certification
- Functionality testing
- Absence of contaminants
For This Transaction:
1. Scan material container label (if barcoded)
2. Enter lot number from container label
3. Verify lot is QA released
4. Verify lot is within expiration/retest date
5. Record lot in batch genealogy
System will create traceability link:
[Material Lot] → [Batch] → [Finished Product Batch]
Cannot proceed without material lot number.
Material Lot Lookup: [Search available lots]
Rule 2: Validate Material Status Before Use
Validation Set: Material - QA Status Check - OnConsumption
Condition:
Action - Message:
Type: Error
Message:
MATERIAL NOT RELEASED BY QA
Material: [Item:Description]
Lot Number: [MaterialLot:LotNo]
Supplier: [MaterialLot:VendorName]
QA Status: [MaterialLot:QAStatus]
Quality Assurance Release Status:
Current Status: [MaterialLot:QAStatus]
Status Options: Quarantine → Testing → Released / Rejected
Material Status Definitions:
QUARANTINE:
- Material received but not yet sampled and tested
- Physically segregated in quarantine area
- Cannot be used in production
TESTING:
- Sample submitted to QA lab
- Testing in progress per specification
- Cannot be used until testing complete
RELEASED:
- All testing complete and specifications met
- Certificate of Analysis (COA) approved
- Authorized for use in production
- ✓ OK TO USE
REJECTED:
- Failed specification testing
- Not suitable for intended use
- Must be returned to supplier or destroyed
- ❌ CANNOT USE
This Material Lot Status:
Status: [MaterialLot:QAStatus]
Received Date: [MaterialLot:ReceiptDate]
Sampled Date: [MaterialLot:SampleDate]
QA Release Date: [MaterialLot:ReleaseDate]
Approved By: [MaterialLot:QAApprover]
[IF([MaterialLot:QAStatus] is 'Quarantine',
'Material is in quarantine awaiting sampling and testing.
Cannot use until QA releases.
Required Actions:
☐ QA samples material per sampling plan
☐ Lab performs identity, purity, potency testing
☐ Results meet specification
☐ QA approves COA
☐ QA changes status to Released
', '')]
[IF([MaterialLot:QAStatus] is 'Testing',
'Material testing is in progress.
Testing Status:
Tests Required: [List from specification]
Tests Complete: [List completed tests]
Tests Pending: [List remaining tests]
Expected Completion: [Date]
Contact QA Lab to expedite if urgent.
', '')]
[IF([MaterialLot:QAStatus] is 'Rejected',
'Material has been REJECTED by Quality Assurance.
Rejection Reason: [MaterialLot:RejectionReason]
Failed Tests: [List of failed specifications]
This lot cannot be used in production.
Disposition:
☐ Return to supplier for credit
☐ Quarantine for reprocessing (if applicable)
☐ Destroy per waste disposal procedures
Select different material lot that is QA Released.
', '')]
cGMP Requirement:
Only materials released by Quality Assurance may be used in drug manufacturing.
Using non-released materials results in:
- Invalid batch
- Batch must be destroyed
- Serious cGMP violation
- FDA enforcement action
Available Released Lots: [List of Released lots for this material]
Part 3: Deviation Management and CAPA
Manufacturing Deviation Documentation
Any departure from approved procedures must be documented and investigated.
Validation Set: Batch Record - Deviation Detection - OnStep
Rule 1: Enforce Deviation Documentation
Table: Batch Record Step (Custom Table)
Condition:
([BatchStep:ActualYield] < [BatchStep:ExpectedYield] * 0.95
OR [BatchStep:ActualYield] > [BatchStep:ExpectedYield] * 1.05)
AND [BatchStep:DeviationNo]
Action - Message:
Type: Error
Message:
YIELD DEVIATION - INVESTIGATION REQUIRED
Batch: [BatchStep:ProductionOrderNo]
Product: [ProdOrder:Item:Description]
Step: [BatchStep:OperationNo] - [BatchStep:Description]
Yield Variance:
Theoretical Yield: [BatchStep:ExpectedYield] [UOM]
Actual Yield: [BatchStep:ActualYield] [UOM]
Variance: [[ActualYield - ExpectedYield] / ExpectedYield × 100]%
⚠️ EXCEEDS ACCEPTABLE YIELD VARIANCE (±5%)
FDA 21 CFR 211.192 - PRODUCTION RECORD REVIEW:
Any unexplained discrepancy or failure of a batch to meet specifications must be investigated.
Deviation Management Process:
1. DOCUMENT DEVIATION
☐ Initiate deviation report
☐ Describe deviation in detail
☐ Record when deviation was discovered
☐ Identify person reporting deviation
2. IMMEDIATE ACTIONS
☐ Assess impact on product quality
☐ Segregate affected material/product
☐ Prevent distribution if quality impacted
☐ Implement containment actions
3. INVESTIGATION
☐ Assign investigation to qualified person
☐ Determine root cause
☐ Review related batches (same period/equipment)
☐ Assess extent of impact
4. CORRECTIVE ACTIONS
☐ Implement immediate correction
☐ Address root cause
☐ Prevent recurrence
5. PREVENTIVE ACTIONS (CAPA)
☐ Identify systematic improvements
☐ Update procedures if needed
☐ Training if human error identified
☐ Equipment modification if appropriate
6. EFFECTIVENESS CHECK
☐ Verify corrective actions effective
☐ Monitor for recurrence
☐ Close deviation after verification
Possible Root Causes for Yield Variance:
LOW YIELD:
- Material loss during transfer
- Equipment holdup
- Sampling removed material
- Spillage
- Calculation error
- Process inefficiency
HIGH YIELD:
- Excess material added (serious concern)
- Foreign material contamination
- Moisture uptake
- Calculation error
- Incomplete mixing from previous batch
Yield variance >10% is particularly concerning and may indicate:
- Process out of control
- Equipment malfunction
- Operator error
- Calculation error
Cannot complete batch step until deviation documented and investigated.
Initiate Deviation Report: [Form link]
Quality Assurance: [Contact]
Rule 2: CAPA Effectiveness Verification
Validation Set: CAPA - Effectiveness Check - Scheduled
Table: CAPA (Custom Table)
Condition:
[CAPA:ImplementationDate] + [CAPA:EffectivenessCheckPeriod] < [T]
AND [CAPA:EffectivenessVerified]
Action - Email:
To: quality.manager, [CAPA:ResponsiblePerson]
Subject: CAPA Effectiveness Check Overdue - [CAPA:No]
Body:
CAPA EFFECTIVENESS VERIFICATION REQUIRED
CAPA Number: [CAPA:No]
Originating Deviation: [CAPA:DeviationNo]
Issue: [CAPA:ProblemDescription]
Root Cause: [CAPA:RootCause]
Corrective Actions Implemented:
[FOR EACH action in CAPA:
Action: [Action description]
Implemented: [Implementation date]
Implemented By: [Person]
]
Implementation Date: [CAPA:ImplementationDate]
Effectiveness Check Due: [CAPA:ImplementationDate + Period]
Days Overdue: [[T] - [Due date]]
CAPA EFFECTIVENESS VERIFICATION:
After implementing corrective/preventive actions, must verify actions are effective.
Effectiveness Verification Methods:
1. TREND ANALYSIS
Review metrics before and after CAPA implementation
Expected: Reduction or elimination of problem
2. PROCESS MONITORING
Monitor process performance over time period
Typical periods: 30 days, 90 days, or several production batches
3. AUDIT/INSPECTION
Verify new procedure being followed
Check training records if training was action
4. TESTING
Retest to confirm issue resolved
For This CAPA:
Original Issue: [CAPA:ProblemDescription]
Occurrence Frequency Before: [CAPA:FrequencyBefore]
Monitoring Period: [CAPA:EffectivenessCheckPeriod] days
Effectiveness Check Questions:
☐ Have there been any recurrences of the original problem?
☐ Are new procedures being followed consistently?
☐ Have relevant personnel been trained?
☐ Have process metrics improved?
☐ Are preventive measures sustainable?
Data to Review:
- Deviation reports since implementation (filter by similar type)
- Batch records (check for similar issues)
- Process monitoring data
- Training records
- Audit findings
Effectiveness Determination:
✓ EFFECTIVE: No recurrence, metrics improved, procedures followed
✗ NOT EFFECTIVE: Problem recurred, metrics unchanged, need additional actions
If Not Effective:
- Revise corrective actions
- Investigate why initial actions insufficient
- Implement enhanced actions
- Schedule new effectiveness check
Complete effectiveness verification within 7 days.
CAPA System: [Link]
Trend Analysis Report: [Link to metrics dashboard]
Part 4: Change Control Management
Change Control Approval Workflows
Any change to process, equipment, materials, or specifications requires formal change control.
Validation Set: Change Control - Approval Routing - OnCreate
Rule 1: Route Change for Impact Assessment
Table: Change Control (Custom Table)
Condition:
[ChangeControl:Status] is 'Initiated'
AND [ChangeControl:ImpactAssessment]
Action - Email:
To: [ChangeControl:Initiator], quality.engineering
Subject: Impact Assessment Required - Change Control [ChangeControl:No]
Body:
CHANGE CONTROL IMPACT ASSESSMENT
Change Control: [ChangeControl:No]
Initiated By: [ChangeControl:InitiatorName]
Date Initiated: [ChangeControl:InitiatedDate]
Proposed Change:
Type: [ChangeControl:ChangeType]
Description: [ChangeControl:ChangeDescription]
Reason: [ChangeControl:Justification]
Affected Areas:
Product: [ChangeControl:ProductAffected]
Process: [ChangeControl:ProcessAffected]
Equipment: [ChangeControl:EquipmentAffected]
Material: [ChangeControl:MaterialAffected]
Specification: [ChangeControl:SpecificationAffected]
IMPACT ASSESSMENT REQUIRED:
FDA expects pharmaceutical companies to have robust change control systems.
ICH Q10 Pharmaceutical Quality System:
Change control ensures changes are proposed, evaluated, approved, implemented, and verified.
Impact Assessment Areas:
1. PRODUCT QUALITY
☐ Will change affect product safety?
☐ Will change affect product efficacy?
☐ Will change affect product quality attributes?
☐ Impact on stability?
2. VALIDATION STATUS
☐ Does change affect validated process?
☐ Is revalidation required?
☐ Is protocol execution needed?
☐ Qualification studies required?
3. REGULATORY
☐ Does change require regulatory notification?
☐ Prior approval supplement required (major change)?
☐ Changes being effected supplement (moderate)?
☐ Annual report notification (minor)?
☐ Multiple markets affected?
4. DOCUMENTATION
☐ Which SOPs require revision?
☐ Which specifications require revision?
☐ Batch record updates needed?
☐ Training materials updates?
☐ Quality agreements affected?
5. MATERIALS/EQUIPMENT
☐ New materials required?
☐ Equipment qualification needed?
☐ Calibration requirements changed?
6. RISK ASSESSMENT
☐ What could go wrong?
☐ Likelihood of risk?
☐ Severity if occurs?
☐ Mitigation strategies?
Change Classification:
MINOR: Low risk, no regulatory notification
MODERATE: Medium risk, CBE-30 supplement
MAJOR: High risk, prior approval required
Required Approvals Based on Impact:
• Quality Assurance: All changes
• Quality Engineering: Process/equipment changes
• Regulatory Affairs: Changes requiring submission
• Manufacturing: Process changes
• Validation: Changes to validated systems
• Management: Major changes
Complete impact assessment within 5 business days.
Impact Assessment Form: [Template]
Change Control System: [Link]
Rule 2: Prevent Implementation Before Approval
Validation Set: Change Control - Implementation Block - OnStatusChange
Condition:
[ChangeControl:Status] is 'Implementing'
AND [ChangeControl:ApprovalComplete]
Action - Message:
Type: Error
Message:
CHANGE IMPLEMENTATION NOT AUTHORIZED
Change Control: [ChangeControl:No]
Description: [ChangeControl:ChangeDescription]
Status: [ChangeControl:Status]
APPROVAL STATUS:
[FOR EACH required approver:
Approver: [Department/Role]
Status: [IF(Approved, '✓ APPROVED ' + [Date], '❌ PENDING')]
[IF(Rejected, '✗ REJECTED: ' + [Rejection reason])]
]
Missing Approvals:
[List departments/roles that haven't approved]
cGMP CHANGE CONTROL REQUIREMENT:
Changes must be formally approved before implementation.
Change Control Process:
1. Initiation → 2. Impact Assessment → 3. Approval → 4. Implementation → 5. Verification
Current Stage: Approval (stage 3)
Cannot proceed to Implementation until all approvals obtained.
Consequences of Unauthorized Changes:
- Unapproved change is a cGMP violation
- Batch produced under unauthorized conditions may be invalid
- Regulatory action (Form 483, Warning Letter)
- Consent decree for repeated violations
- Loss of regulatory approval
- Criminal prosecution in extreme cases
"Approved" means:
• All required functional areas have reviewed
• Each reviewer has electronically signed approval
• No outstanding rejections or requests for revision
• Change Control Coordinator has verified complete
If Urgent Change Needed:
Some systems allow "emergency change" process:
1. Document emergency justification
2. Implement with limited approval
3. Complete full approval process retrospectively
4. Verify change was appropriate
This change does not qualify for emergency process.
Wait for all approvals before implementing change.
Pending Approvers: [Contact list with reminder emails]
Change Control Coordinator: [Contact]
Part 5: Product Serialization and DSCSA
Drug Supply Chain Security Act Compliance
DSCSA requires serialization at package and case levels for traceability.
Validation Set: Finished Goods - Serialization - OnPackaging
Rule 1: Assign Serial Numbers to Saleable Units
Table: Production Output (Custom Table)
Condition:
[Item:CustomPrescriptionDrug] is true
AND [ProductionOutput:SerialNumber] is ''
AND [ProductionOutput:PackagingLevel]
Action - Message:
Type: Error
Message:
PRODUCT SERIALIZATION REQUIRED - DSCSA
Batch: [ProductionOutput:BatchNo]
Product: [Item:Description]
NDC: [Item:CustomNDC]
Packaging Level: [ProductionOutput:PackagingLevel]
Quantity: [ProductionOutput:Quantity]
DRUG SUPPLY CHAIN SECURITY ACT (DSCSA):
FDA requires serialization of prescription drug packages for traceability.
Serialization Requirements:
SALEABLE UNIT (Individual Package):
- Unique serial number
- 2D Data Matrix barcode
- Human-readable interpretation
Required Data Elements:
• Product Identifier (NDC or GTIN)
• Serial Number (unique to this package)
• Lot Number
• Expiration Date
Data Format: GS1 SGTIN (Serialized Global Trade Item Number)
HOMOGENEOUS CASE:
- Contains packages with same product/lot/expiration
- Serial number for case
- Aggregation linking case to contained packages
Serial Number Generation:
Serial numbers must be:
✓ Unique per GTIN
✓ Randomized (not sequential)
✓ Non-intelligible (cannot infer information from serial)
✓ Maintained in repository
✓ Reported to FDA
✓ Transferred in transaction information
2D Barcode Requirements:
- GS1 Data Matrix
- Minimum size per package dimensions
- Verification: ISO/IEC 15415 grade
- Placement: Per artwork specifications
DSCSA Traceability Events:
1. COMMISSION: Serial number assigned during packaging
2. AGGREGATION: Package into case (parent-child relationship)
3. SHIPPING: Transfer to wholesaler with transaction data
4. RECEIVING: Wholesaler receives and verifies
5. DECOMMISSION: Dispensed to patient or destroyed
For This Transaction:
1. Request serial numbers from Serialization System
2. Print 2D Data Matrix barcode on label
3. Apply label to package
4. Vision system verifies barcode quality
5. Record commission event
6. If packaging into cases, record aggregation
Serial Number Repository:
All serial numbers must be maintained in repository enabling:
- Verification at each supply chain step
- Investigation of suspect/illegitimate products
- Recall targeting specific serial numbers
Consequences of Non-Serialization:
- Cannot distribute product (violation of DSCSA)
- FDA enforcement action
- Product quarantine
- Rework to apply serialization
- Delayed shipments
Integrate with Serialization System: [Link]
Vision Inspection System: [Status]
Rule 2: Validate Serial Number Uniqueness
Validation Set: Serialization - Uniqueness Check - OnAssignment
Condition:
EXISTS(SerialNumber WHERE [GTIN] = [Current:GTIN]
AND [SerialNumber] = [Current:SerialNumber]
AND [AssignedDate] < [T]
Action - Message:
Type: Error
Message:
DUPLICATE SERIAL NUMBER DETECTED
Product: [Item:Description]
GTIN: [Item:GTIN]
Serial Number: [SerialNumber]
⚠️ This serial number has already been assigned.
Previous Assignment:
Serial Number: [PreviousAssignment:SerialNumber]
Assigned Date: [PreviousAssignment:AssignedDate]
Batch: [PreviousAssignment:BatchNo]
Packaging Line: [PreviousAssignment:PackagingLine]
Status: [PreviousAssignment:Status]
DSCSA REQUIREMENT:
Serial numbers must be unique within a GTIN (product identifier).
Duplicate Serial Number Causes:
1. Serialization system error
2. Rework without decommissioning original serial
3. Serial number pool exhausted
4. Database synchronization issue
5. Manual entry error
Consequences of Duplicate Serials:
- Traceability broken (cannot distinguish packages)
- Supply chain partners cannot verify authenticity
- Recall complications (wrong product might be targeted)
- DSCSA non-compliance
- FDA enforcement
Required Actions:
1. STOP packaging line immediately
2. Quarantine packages with duplicate serials
3. Investigate root cause
4. Decommission invalid serials in repository
5. Request new serial number pool
6. Resume packaging with valid serials
7. Document incident in deviation system
If Rework Situation:
- Original serial must be decommissioned in repository before reassignment
- Ideally, assign new serial rather than reusing
- Document reason for serial change
Serial Number Management:
- Request pools in advance
- Monitor pool depletion
- Automatic pool replenishment
- Validation checks before assignment
Serialization System Administrator: [Contact]
Quality Assurance: [Contact - for deviation documentation]
Summary and Key Takeaways
This guide covered pharmaceutical and life sciences validations:
Batch record integrity with cGMP compliance and 21 CFR Part 11 electronic signatures
Material traceability from API through finished product with lot genealogy
Deviation management with CAPA and effectiveness verification
Change control with impact assessment and approval workflows
Product serialization per DSCSA with uniqueness validation
Pharmaceutical compliance benefits:
Automated batch record completeness checking
Dual verification enforcement
Material QA status validation
Deviation detection and investigation workflow
Change control authorization
Serial number assignment and verification
Complete audit trail for regulatory inspection
Patient safety protection
Implementation considerations:
Integration with Manufacturing Execution System (MES)
LIMS (Laboratory Information Management System) interface
Electronic batch record system integration
Serialization platform connectivity
21 CFR Part 11 compliant electronic signature
Document management system linkage
Validation per GAMP 5 guidelines
Related topics:
Blog 041: Healthcare Solutions (medical device and safety patterns)
Blog 044: Food and Beverage Solutions (similar traceability and safety requirements)
Blog 036: Manufacturing Solutions (production and quality patterns)
Blog 035: Versioning and Change Management (change control patterns)
This blog is part of the QUALIA Rule Engine series for Microsoft Dynamics 365 Business Central. Follow along as we explore business rule automation patterns.
