EBR Glossary

ALCOA / ALCOA+ALCOA+ ensures trustworthy GxP data through nine core data integrity principles.

Batch Production Record (BPR)BPR records actual batch execution, capturing production data, approvals, and deviations in real time.

Batch ReleaseBatch release is QA approval confirming a batch meets quality and regulatory requirements.

Bill of Materials (BOM)BOM lists required materials and quantities, driving batch production and dispensing.

Certificate of Analysis (CoA)CoA verifies a batch meets specifications through testing for material acceptance and product release.

Chain of CustodyChain of custody tracks handling to ensure data and materials remain secure and untampered.

Computer System Validation (CSV) / CSA (Computer Software Assurance)CSV/CSA ensure computerized systems are validated using a risk-based assurance approach.

Configuration vs. CustomizationConfiguration uses built-in settings; customization changes code to add new functionality.

Critical Process Parameter (CPP)CPPs are critical process variables controlled within limits to ensure consistent product quality.

Critical Quality Attribute (CQA)CQAs are critical product characteristics that must meet limits to ensure quality and safety.

Data IntegrityData integrity ensures data remains complete, consistent, and accurate throughout its lifecycle.

eBMR (Electronic Batch Manufacturing Record)eBMR is the UK/EU term for electronic batch records with secure, auditable documentation.

Electronic Signature (e-signature)Electronic signatures provide secure, legally binding approval and traceability in digital records.

Equipment Log / Equipment QualificationEquipment logs track history, while qualification verifies equipment readiness for GMP use.

ERP (Enterprise Resource Planning)ERP integrates business operations and connects with MES and EBR for seamless data flow.

EU Annex 11EU Annex 11 sets GMP requirements for validated, secure, and compliant computerized systems.

Exception/Deviation HandlingException handling documents, investigates, and resolves deviations during batch execution.

First Pass Yield (FPY)First Pass Yield measures batches completed right the first time, without rework or deviations.

Form 483Form 483 lists FDA inspection observations requiring a formal company response.

GAMP 5 (Good Automated Manufacturing Practice)GAMP 5 is a risk-based framework for validating GxP computerized systems.

Genealogy/TraceabilityGenealogy tracks complete batch history, linking materials, equipment, personnel, and processes.

Historian (Data Historian)Data historian stores time-series process data for automated, traceable manufacturing records.

Hybrid SystemHybrid systems combine electronic and paper records during transitions to digital documentation.

In-Process Control (IPC)In-process control monitors production with real-time checks to ensure process quality.

LIMS (Laboratory Information Management System)LIMS manages lab data and integrates test results directly into electronic batch records.

Line ClearanceLine clearance verifies equipment and areas are ready, preventing contamination and mix-ups.

Master Batch Record (MBR)MBR is the approved template defining standard manufacturing instructions for each product.

MES (Manufacturing Execution System)MES manages real-time production, often including electronic batch record functionality.

Non-Conformance (NC)Non-conformances are failures to meet requirements, requiring documentation and investigation.

OOS (Out of Specification)OOS results fall outside limits and require investigation before batch disposition.

OOT (Out of Trend)OOT results are within limits but indicate unusual trends requiring process review.

Order ManagementOrder management creates and tracks production orders, triggering EBR generation through ERP integration.

Paperless ManufacturingPaperless manufacturing replaces paper with electronic systems for GMP production records.

Real-Time Release Testing (RTRT)RTRT uses in-process data and controls to release batches without end-product testing.

Review by ExceptionReview by exception focuses QA review on flagged issues instead of checking every data point.

SerializationSerialization assigns unique IDs to products for tracking and linking units to batch records.

Site Master File (SMF)Site Master File describes a facility’s GMP activities, quality systems, and manufacturing capabilities.

SOP (Standard Operating Procedure)SOPs provide controlled instructions for tasks and guide operators during EBR execution.

System Validation LifecycleSystem validation lifecycle covers planning, qualification, operation, maintenance, and retirement.

Technology TransferTechnology transfer moves validated manufacturing processes and records between sites or scales.

Time-StampingTime-stamping records exact action times to ensure data integrity and traceability.

TraceabilityTraceability tracks a batch’s full history from raw materials through production and distribution.

Unit OperationUnit operations are defined manufacturing steps with controlled parameters and documentation.

URS (User Requirements Specification)URS defines system needs and serves as the basis for validation and testing.

User Access ControlsUser access controls restrict system actions by role to ensure security and compliance.

Validation Master Plan (VMP)VMP defines the overall strategy and framework for validation across systems and processes.

Version ControlVersion control manages approved document revisions while preserving revision history for audits.

Weigh and DispenseWeigh and dispense ensures accurate material quantities using real-time verification.

Yield (Theoretical vs. Actual)Theoretical vs. actual yield compares expected and produced output to identify batch variances.