Manufacturing Batch Record Template

---
title: "Manufacturing Batch Record Template"
methodology: "universal"
complexity: "advanced"
owner: "mirichard"
updated: "2026-09-19"
primary_principles: ["stewardship", "quality-by-design"]
secondary_principles: ["evidence-based-decisions"]
principle_rationale: "Captures manufacturing execution, material reconciliation and deviations in a controlled record for accountable quality review and disposition."
---

# Manufacturing Batch Record Template

## When to Use

- When preparing a manufacturing batch record tailored to the approved site process.
- When operations and quality must capture execution, reconciliation, and deviations consistently.

## When NOT to Use

- As a second conflicting master record for a batch already governed by an approved system.
- Do not treat completed metadata or a filled checklist as evidence that the underlying work is done. See [Metadata theater](../../../../../docs/principles/anti-patterns.md#metadata-theater).

## Pairs Well With

- [Batch Record Template](../../../../../domains/delivery/industry-specializations/healthcare-pharmaceutical/manufacturing/batch_record_template.md).
- [Process Control Template](../../../../../domains/delivery/industry-specializations/healthcare-pharmaceutical/manufacturing/process_control_template.md).

Selection context: Delivery domain; universal methodology; advanced complexity. Match the situations above to project phase, risk, team size, and industry using the [decision-engine context model](../../../../../meta/architecture-research/800-801-context-assessment-model.md).

## Applying this template

Treat filled examples, dates, numerical limits, sampling frequencies, and approval outcomes as illustrations. Before execution, replace them with the approved product/site requirements, scientific rationale, method references, responsible reviewer, and acceptance evidence. Record the applicable jurisdiction and current guidance edition; a completed worksheet alone does not demonstrate regulatory compliance.

| Requirement or limit | Applicable source / edition | Product-specific rationale | Approval / date | Execution evidence |
|---|---|---|---|---|
| [Requirement] | [Source] | [Rationale] | [Reviewer / date] | [Record] |


## Document Control

**Document ID:** [MBR-XXX]\
**Version:** [1.0]  
**Effective Date:** [YYYY-MM-DD]  
**Review Date:** [YYYY-MM-DD]  
**Supersedes:** [Previous version, if applicable]  
**Product:** [Product Name]  
**Classification:** [e.g., Sterile/Non-sterile, Controlled Substance Class]  
**Last Updated:** [YYYY-MM-DD]

### Document History

| Version | Date | Description of Change | Author | Approved By |
|---------|------|------------------------|--------|------------|
| 1.0 | YYYY-MM-DD | Initial release | [Name] | [Name] |

### Distribution List

| Name | Department/Role | Date Distributed |
|------|----------------|------------------|
| [Name] | [Department/Role] | [YYYY-MM-DD] |
| [Name] | [Department/Role] | [YYYY-MM-DD] |

### Retention Period

This document must be retained for a minimum of [X] years after the expiry date of the relevant batch or as required by applicable regulations, whichever is longer.

---

## 1. Batch Record Header

### 1.1 Product Information

| Field | Information |
|-------|-------------|
| **Product Name** | [Product name as per marketing authorization] |
| **Product Code** | [Internal product code] |
| **Dosage Form** | [Tablet/Capsule/Injectable/Cream/etc.] |
| **Strength** | [e.g., 10 mg, 50 mg/ml, etc.] |
| **Batch Size** | [Standard batch size, e.g., 100,000 tablets] |
| **Pharmacopeia Reference** | [USP/BP/EP/JP/IP, etc.] |
| **Marketing Authorization Number** | [If applicable] |

### 1.2 Batch Identification

| Field | Information | Verified By | Date |
|-------|-------------|-------------|------|
| **Batch Number** | [Unique batch identifier] | | |
| **Manufacturing Date** | [YYYY-MM-DD] | | |
| **Expiry Date** | [YYYY-MM-DD] | | |
| **Campaign Number** | [If applicable] | | |
| **Manufacturing Location** | [Facility name and address] | | |
| **Manufacturing Suite/Line** | [Specific production area] | | |

### 1.3 Manufacturing Authorization

| Role | Name | Signature | Date |
|------|------|-----------|------|
| **Production Manager** | | | |
| **Quality Assurance** | | | |

> **Note:** Production shall not commence without proper authorization. Ensure all pre-production checks are completed and documented.

---

## 2. Material Section

### 2.1 Raw Materials

| Material Name | Material Code | Required Quantity | Batch Number | Expiry Date | Vendor | Weighed Quantity | Weighed By | Verified By | Date |
|---------------|--------------|-------------------|--------------|-------------|--------|------------------|-----------|------------|------|
| [Material 1] | [Code] | [Quantity with units] | | | | | | | |
| [Material 2] | [Code] | [Quantity with units] | | | | | | | |
| [Material 3] | [Code] | [Quantity with units] | | | | | | | |

### 2.2 Material Verification Checklist

- [ ] All raw materials verified against specifications
- [ ] All raw materials are within expiry date
- [ ] All raw material containers are intact and properly labeled
- [ ] All raw materials have passed quality control testing
- [ ] All material dispensing performed in appropriate conditions (temperature, humidity)
- [ ] Cross-contamination prevention measures followed
- [ ] Balance/scale calibration verified and within valid date
- [ ] Material weighing calculations double-checked
- [ ] All material movement documented in inventory/ERP system

### 2.3 Packaging Materials

| Material Name | Material Code | Required Quantity | Batch Number | Expiry Date | Vendor | Issued Quantity | Issued By | Verified By | Date |
|---------------|--------------|-------------------|--------------|-------------|--------|-----------------|-----------|------------|------|
| [Primary container] | [Code] | [Quantity with units] | | | | | | | |
| [Closure system] | [Code] | [Quantity with units] | | | | | | | |
| [Label] | [Code] | [Quantity with units] | | | | | | | |
| [Carton] | [Code] | [Quantity with units] | | | | | | | |

### 2.4 Label Verification

| Check | Verified By | Date |
|-------|------------|------|
| Label content matches product specification | | |
| Batch number correctly printed | | |
| Expiry date correctly printed | | |
| Storage conditions correctly stated | | |
| Barcode/serialization (if applicable) verified | | |
| Controlled substance warnings (if applicable) | | |
| Patient information leaflet verified | | |

---

## 3. Equipment and Room Preparation

### 3.1 Manufacturing Rooms

| Room ID | Purpose | Required Conditions | Actual Conditions | Verified By | Date |
|---------|---------|---------------------|------------------|------------|------|
| [Room ID] | [e.g., Weighing] | Temperature: [20-25°C]<br>Humidity: [30-60% RH]<br>Differential Pressure: [≥10 Pa] | Temp: [     ]<br>Humidity: [     ]<br>Diff Pressure: [     ] | | |
| [Room ID] | [e.g., Granulation] | Temperature: [20-25°C]<br>Humidity: [30-60% RH]<br>Differential Pressure: [≥10 Pa] | Temp: [     ]<br>Humidity: [     ]<br>Diff Pressure: [     ] | | |
| [Room ID] | [e.g., Compression] | Temperature: [20-25°C]<br>Humidity: [30-60% RH]<br>Differential Pressure: [≥10 Pa] | Temp: [     ]<br>Humidity: [     ]<br>Diff Pressure: [     ] | | |

### 3.2 Line Clearance

| Check | Status | Verified By | Date |
|-------|--------|------------|------|
| Previous batch materials removed | | | |
| Equipment cleaned and status labeled | | | |
| Room cleaned and status labeled | | | |
| No materials from other products present | | | |
| Line clearance documented with photographs (if applicable) | | | |
| All documentation from previous batch removed | | | |
| Line clearance approved by QA | | | |

### 3.3 Equipment List

| Equipment | Equipment ID | Calibration Due Date | Clean Status | Preventive Maintenance Status | Verified By | Date |
|-----------|-------------|----------------------|--------------|------------------------------|------------|------|
| [Equipment 1, e.g., Mixer] | [ID] | [YYYY-MM-DD] | | | | |
| [Equipment 2, e.g., Mill] | [ID] | [YYYY-MM-DD] | | | | |
| [Equipment 3, e.g., Tablet Press] | [ID] | [YYYY-MM-DD] | | | | |
| [Equipment 4, e.g., Coating System] | [ID] | [YYYY-MM-DD] | | | | |

### 3.4 Equipment Setup and Verification

| Equipment | Parameter | Specification | Actual Setting | Verified By | Date |
|-----------|-----------|---------------|---------------|------------|------|
| [Equipment 1] | [e.g., Speed] | [e.g., 20-25 RPM] | | | |
| [Equipment 1] | [e.g., Time] | [e.g., 15 ± 1 min] | | | |
| [Equipment 2] | [e.g., Speed] | [e.g., 50-60 RPM] | | | |
| [Equipment 2] | [e.g., Temperature] | [e.g., 50 ± 2°C] | | | |

### 3.5 Computerized Systems Check (if applicable)

| System | System ID | Version | Backup Status | Data Integrity Controls | Verified By | Date |
|--------|-----------|---------|--------------|-------------------------|------------|------|
| [System 1, e.g., EBR] | [ID] | [Version] | | | | |
| [System 2, e.g., SCADA] | [ID] | [Version] | | | | |

---

## 4. Manufacturing Instructions

### 4.1 Process Step 1: [Step Name, e.g., Raw Material Dispensing]

**Purpose:** [Brief description of the step purpose]

**Materials Required:**
- [Material 1]
- [Material 2]

**Equipment Required:**
- [Equipment 1]
- [Equipment 2]

**Procedure:**

1. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

2. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

3. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

**In-Process Control:**

| Test | Specification | Result | Tested By | Verified By | Date |
|------|---------------|--------|-----------|------------|------|
| [IPC Test 1] | [Specification] | | | | |
| [IPC Test 2] | [Specification] | | | | |

### 4.2 Process Step 2: [Step Name, e.g., Granulation]

**Purpose:** [Brief description of the step purpose]

**Materials Required:**
- [Material 1]
- [Material 2]

**Equipment Required:**
- [Equipment 1]
- [Equipment 2]

**Procedure:**

1. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

2. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

3. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

**In-Process Control:**

| Test | Specification | Result | Tested By | Verified By | Date |
|------|---------------|--------|-----------|------------|------|
| [IPC Test 1] | [Specification] | | | | |
| [IPC Test 2] | [Specification] | | | | |

### 4.3 Process Step 3: [Step Name, e.g., Compression/Filling/etc.]

**Purpose:** [Brief description of the step purpose]

**Materials Required:**
- [Material 1]
- [Material 2]

**Equipment Required:**
- [Equipment 1]
- [Equipment 2]

**Procedure:**

1. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

2. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

3. [Detailed instruction]
   - Critical Parameter: [Specification]
   - Acceptance Criteria: [Criteria]
   - Actual Value: _____________ Operator: _____________ Date: _____________
   - Verified By: _____________ Date: _____________

**In-Process Control:**

| Test | Specification | Sampling Frequency | Results | Tested By | Verified By | Date |
|------|---------------|-------------------|---------|-----------|------------|------|
| [IPC Test 1] | [Specification] | [e.g., Every 30 minutes] | | | | |
| [IPC Test 2] | [Specification] | [e.g., Start, middle, end] | | | | |

### 4.4 Critical Process Parameters Summary

| Process Step | Parameter | Specification | Action Limit | Critical Limit | Frequency of Monitoring | Risk Level | Control Strategy |
|--------------|-----------|---------------|--------------|----------------|-------------------------|-----------|-----------------|
| [Process Step 1] | [Parameter] | [Specification] | [Action Limit] | [Critical Limit] | [Frequency] | [High/Medium/Low] | [Control Strategy] |
| [Process Step 2] | [Parameter] | [Specification] | [Action Limit] | [Critical Limit] | [Frequency] | [High/Medium/Low] | [Control Strategy] |
| [Process Step 3] | [Parameter] | [Specification] | [Action Limit] | [Critical Limit] | [Frequency] | [High/Medium/Low] | [Control Strategy] |

---

## 5. Environmental Monitoring Requirements

### 5.1 Non-Viable Particle Monitoring

| Location | Cleanroom Grade | Acceptance Criteria "At Rest" | Acceptance Criteria "In Operation" | Results | Performed By | Verified By | Date |
|----------|----------------|-------------------------------|-----------------------------------|---------|--------------|------------|------|
| [Location 1] | [Grade A/B/C/D] | ≥0.5μm: [Limit] particles/m³<br>≥5.0μm: [Limit] particles/m³ | ≥0.5μm: [Limit] particles/m³<br>≥5.0μm: [Limit] particles/m³ | | | | |
| [Location 2] | [Grade A/B/C/D] | ≥0.5μm: [Limit] particles/m³<br>≥5.0μm: [Limit] particles/m³ | ≥0.5μm: [Limit] particles/m³<br>≥5.0μm: [Limit] particles/m³ | | | | |

### 5.2 Viable Monitoring

| Location | Cleanroom Grade | Method | Acceptance Criteria | Frequency | Results | Performed By | Verified By | Date |
|----------|----------------|--------|---------------------|-----------|---------|--------------|------------|------|
| [Location 1] | [Grade A/B/C/D] | [e.g., Active air, Settle plate] | ≤[X] CFU/plate or m³ | [Frequency] | | | | |
| [Location 2] | [Grade A/B/C/D] | [e.g., Surface sample] | ≤[X] CFU/contact plate | [Frequency] | | | | |
| [Location 3] | [Grade A/B/C/D] | [e.g., Glove print] | ≤[X] CFU/glove | [Frequency] | | | | |

### 5.3 Environmental Conditions Monitoring

| Parameter | Location | Frequency | Specification | Reading Time | Result | Performed By | Verified By |
|-----------|----------|-----------|---------------|--------------|--------|--------------|------------|
| Temperature | [Location] | [Frequency] | [Specification] | [Time 1] | | | |
| | | | | [Time 2] | | | |
| Humidity | [Location] | [Frequency] | [Specification] | [Time 1] | | | |
| | | | | [Time 2] | | | |
| Differential Pressure | [Location] | [Frequency] | [Specification] | [Time 1] | | | |
| | | | | [Time 2] | | | |
| Air Changes | [Location] | [Frequency] | [Specification] | [Time] | | | |
| Air Velocity | [Location] | [Frequency] | [Specification] | [Time] | | | |

### 5.4 Personnel Monitoring (for sterile products)

| Monitoring Type | Person/Position | Frequency | Acceptance Criteria | Results | Performed By | Verified By | Date |
|-----------------|----------------|-----------|---------------------|---------|--------------|------------|------|
| Glove prints | [Position] | [Frequency] | ≤[X] CFU/glove | | | | |
| Gown/garment testing | [Position] | [Frequency] | ≤[X] CFU/sample | | | | |

---

## 6. Cleaning Verification

### 6.1 Equipment Cleaning

| Equipment | Cleaning Procedure | Acceptance Criteria | Result | Verified By | Date |
|-----------|-------------------|---------------------|--------|------------|------|
| [Equipment 1] | [SOP Reference] | Visual inspection: No residue<br>pH test: [Specification]<br>Swab test: [Specification] | | | |
| [Equipment 2] | [SOP Reference] | Visual inspection: No residue<br>pH test: [Specification]<br>Swab test: [Specification] | | | |
| [Equipment 3] | [SOP Reference] | Visual inspection: No residue<br>pH test: [Specification]<br>Swab test: [Specification] | | | |

### 6.2 Room Cleaning

| Room | Cleaning Procedure | Acceptance Criteria | Result | Verified By | Date |
|------|-------------------|---------------------|--------|------------|------|
| [Room 1] | [SOP Reference] | Visual inspection: Clean<br>No residues from previous batch | | | |
| [Room 2] | [SOP Reference] | Visual inspection: Clean<br>No residues from previous batch | | | |

### 6.3 Line Clearance for Next Batch

| Check | Status | Verified By | Date |
|-------|--------|------------|------|
| All product containers removed | | | |
| All documentation removed | | | |
| All labels removed | | | |
| Equipment cleaned and status updated | | | |
| Room cleaned and status updated | | | |
| Line clearance approved by QA | | | |

---

## 7. Batch Reconciliation

### 7.1 Raw Material Reconciliation

| Material | Initial Quantity | Used Quantity | Returned Quantity | Loss | % Loss | Acceptable Loss | Acceptable (Y/N) |
|----------|-----------------|---------------|-------------------|------|--------|----------------|-----------------|
| [Material 1] | | | | | | ≤[X]% | |
| [Material 2] | | | | | | ≤[X]% | |
| [Material 3] | | | | | | ≤[X]% | |

### 7.2 Packaging Material Reconciliation

| Material | Initial Quantity | Used Quantity | Returned Quantity | Rejected Quantity | Reconciliation | Acceptable (Y/N) |
|----------|-----------------|---------------|-------------------|-------------------|----------------|-----------------|
| [Material 1] | | | | | | |
| [Material 2] | | | | | | |
| [Material 3] | | | | | | |

### 7.3 Yield Reconciliation

| Stage | Theoretical Yield | Actual Yield | % Yield | Acceptable Range | Acceptable (Y/N) | Comments |
|-------|------------------|--------------|---------|-----------------|-----------------|----------|
| [Stage 1] | | | | [e.g., 95.0-102.0%] | | |
| [Stage 2] | | | | [e.g., 95.0-102.0%] | | |
| Final Product | | | | [e.g., 95.0-102.0%] | | |

### 7.4 Reconciliation Approval

| Role | Name | Signature | Date |
|------|------|-----------|------|
| **Production Supervisor** | | | |
| **Quality Assurance** | | | |

> **Note:** Any discrepancy outside acceptable limits must be investigated and documented as a deviation.

---

## 8. Deviation Recording and Management

### 8.1 Process Deviations

| Deviation No. | Description | Process Step | Date Observed | Reported By | Impact Assessment | CAPA | Risk Level | Status |
|---------------|-------------|--------------|--------------|------------|-------------------|------|-----------|--------|
| | | | | | | | | |
| | | | | | | | | |

### 8.2 Equipment Deviations

| Deviation No. | Equipment | Description | Date Observed | Reported By | Impact Assessment | CAPA | Risk Level | Status |
|---------------|-----------|-------------|--------------|------------|-------------------|------|-----------|--------|
| | | | | | | | | |
| | | | | | | | | |

### 8.3 Environmental Deviations

| Deviation No. | Parameter | Description | Date Observed | Reported By | Impact Assessment | CAPA | Risk Level | Status |
|---------------|-----------|-------------|--------------|------------|-------------------|------|-----------|--------|
| | | | | | | | | |
| | | | | | | | | |

### 8.4 Deviation Investigation and Resolution Summary

| Deviation No. | Root Cause Analysis | Product Impact | QA Assessment | Resolution | Preventive Actions | Closed By | Date Closed |
|---------------|---------------------|----------------|--------------|------------|-------------------|-----------|------------|
| | | | | | | | |
| | | | | | | | |

---

## 9. Quality Review and Disposition

### 9.1 Batch Record Review Checklist

| Check | Status | Comments | Reviewed By | Date |
|-------|--------|----------|------------|------|
| All pages present and in order | | | | |
| All required signatures present | | | | |
| All critical process parameters within specification | | | | |
| All in-process controls within specification | | | | |
| Batch reconciliation acceptable | | | | |
| All deviations documented and resolved | | | | |
| Environmental monitoring results acceptable | | | | |
| Cleaning verification acceptable | | | | |
| All electronic data reviewed and verified | | | | |
| All calculations verified | | | | |

### 9.2 Quality Control Test Results

| Test | Specification | Results | Compliance (Y/N) | Tested By | Date | Verified By | Date |
|------|---------------|---------|------------------|-----------|------|------------|------|
| [Test 1] | [Specification] | | | | | | |
| [Test 2] | [Specification] | | | | | | |
| [Test 3] | [Specification] | | | | | | |
| [Test 4] | [Specification] | | | | | | |

### 9.3 Stability Sample Collection (if applicable)

| Sample Type | Quantity | Storage Condition | Collected By | Verified By | Date |
|-------------|----------|-------------------|--------------|------------|------|
| [Long-term stability] | [Quantity] | [e.g., 25°C/60% RH] | | | |
| [Accelerated stability] | [Quantity] | [e.g., 40°C/75% RH] | | | |
| [In-use stability] | [Quantity] | [e.g., Room temperature] | | | |

### 9.4 Batch Disposition

| Disposition | Comments |
|-------------|----------|
| [ ] Released | |
| [ ] Released with deviation | |
| [ ] Rejected | |
| [ ] Pending further testing | |

### 9.5 Final Approval

| Role | Name | Signature | Date |
|------|------|-----------|------|
| **Production Manager** | | | |
| **Quality Control Manager** | | | |
| **Quality Assurance Manager** | | | |
| **Qualified Person/QA Release** | | | |

---

## Appendices

### Appendix A: Batch Manufacturing Formula

[Detailed manufacturing formula including all ingredients, their quantities, and manufacturing overages]

### Appendix B: Equipment Printouts

[List and attach all equipment printouts, e.g., temperature charts, process parameter logs]

### Appendix C: Analytical Test Methods

[Reference to analytical test methods used for in-process and finished product testing]

### Appendix D: Reference Documents

1. Master Manufacturing Formula [Document ID]
2. Product Specification File [Document ID]
3. Process Validation Protocol [Document ID]
4. Relevant Standard Operating Procedures:
   - SOP-XXX: Equipment Operation
   - SOP-XXX: Line Clearance
   - SOP-XXX: Cleaning Procedures
   - SOP-XXX: Environmental Monitoring
   - SOP-XXX: Deviation Management
   - SOP-XXX: Batch Record Review
   - SOP-XXX: Change Control Management
   - SOP-XXX: Product Quality Review

### Appendix E: GMP Guidance for Batch Record Completion

#### General Guidelines:
1. **Data Recording:**
   - All entries must be made in indelible ink (blue or black)
   - All entries must be clear, legible, and contemporaneous
   - No blank spaces should be left - draw a line through any space not used
   - Never use correction fluid or completely obscure an entry

2. **Error Correction:**
   - Draw a single line through the error
   - Enter the correct information
   - Initial and date the correction
   - Provide reason for correction where needed

3. **Critical Information:**
   - All critical process parameters must be verified by a second person
   - All calculations must be independently checked and verified
   - Any deviation from specifications must be immediately reported and documented

4. **Electronic Records:** (if applicable)
   - Follow system access controls
   - Ensure audit trail functionality is active
   - Electronic signatures must comply with 21 CFR Part 11
   - Backup procedures must be followed

#### Regulatory References:
- FDA 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
- FDA 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
- FDA 21 CFR Part 211.186 - Master Production and Control Records
- FDA 21 CFR Part 211.188 - Batch Production and Control Records
- FDA 21 CFR Part 211.192 - Production Record Review
- FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures
- EU GMP Chapter 4 - Documentation
- EU GMP Chapter 5 - Production
- EU GMP Chapter 6 - Quality Control
- EU GMP Annex 1 - Manufacture of Sterile Medicinal Products (if applicable)
- EU GMP Annex 11 - Computerized Systems
- EU GMP Annex 15 - Qualification and Validation
- EU GMP Annex 16 - Certification by a Qualified Person and Batch Release
- ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ICH Q8 - Pharmaceutical Development
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products

### Appendix F: Example Batch Record Entry

#### Example of Properly Completed Manufacturing Step:

**Process Step: Blending**

**Procedure:**
1. Transfer sifted materials to the blender.
   - Critical Parameter: Transfer time after sifting
   - Acceptance Criteria: ≤ 30 minutes
   - Actual Value: _20 minutes_ Operator: _JSmith_ Date: _2025-06-15_
   - Verified By: _MJones_ Date: _2025-06-15_

2. Blend for specified time.
   - Critical Parameter: Blending time
   - Acceptance Criteria: 15 ± 1 minutes
   - Actual Value: _15.5 minutes_ Operator: _JSmith_ Date: _2025-06-15_
   - Verified By: _MJones_ Date: _2025-06-15_

3. Record blender settings.
   - Critical Parameter: Blender speed
   - Acceptance Criteria: 20 ± 2 RPM
   - Actual Value: _19 RPM_ Operator: _JSmith_ Date: _2025-06-15_
   - Verified By: _MJones_ Date: _2025-06-15_

**In-Process Control:**

| Test | Specification | Result | Tested By | Verified By | Date |
|------|---------------|--------|-----------|------------|------|
| Blend uniformity | RSD ≤ 5.0% | 3.2% | JSmith | MJones | 2025-06-15 |
| Bulk density | 0.45-0.55 g/mL | 0.51 g/mL | JSmith | MJones | 2025-06-15 |

#### Example of Error Correction:

**Procedure:**
1. Add ingredient slowly over specified time.
   - Critical Parameter: Addition time
   - Acceptance Criteria: 5 ± 1 minutes
   - Actual Value: ~~10 minutes~~ 6 minutes JS 2025-06-15 (Transcription error) Operator: _JSmith_ Date: _2025-06-15_
   - Verified By: _MJones_ Date: _2025-06-15_

#### Example of Deviation Recording:

**Deviation No.:** DEV-2025-123

**Description:** During compression, tablet hardness was found to be 12.5 kP at 10:30 check, which exceeds the upper specification limit of 12.0 kP.

**Process Step:** Compression

**Date Observed:** 2025-06-15

**Reported By:** JSmith

**Impact Assessment:** 100 tablets produced between 10:00-10:30 potentially affected. Batch segregated for further evaluation.

**CAPA:** Compression force adjusted to lower setting. Additional hardness testing performed on subsequent tablets which were within specification.

**Status:** Closed - QA approved continuation of batch with segregation of affected tablets. See Deviation Report DEV-2025-123 for full details.