Cleaning Validation Risk Assessment Template for Indonesia

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Key Requirements PROMPT example:

Cleaning Validation Risk Assessment

"I need a Cleaning Validation Risk Assessment for our new multi-product pharmaceutical manufacturing facility in Jakarta, focusing particularly on shared equipment for both sterile and non-sterile products, to be implemented by March 2025."

Document background

The Cleaning Validation Risk Assessment is a critical document required for manufacturing facilities operating under Indonesian regulations, particularly BPOM guidelines and GMP requirements. It is implemented when establishing new cleaning procedures, modifying existing processes, or as part of periodic review requirements. The document systematically evaluates cleaning-related risks in manufacturing processes, including cross-contamination potential, residue limits, and cleaning effectiveness. It forms the basis for cleaning validation protocols and is essential for both initial facility qualification and ongoing compliance with Indonesian regulatory requirements. The assessment must align with BPOM Regulation No. 34 of 2018 regarding Good Manufacturing Practice Guidelines and related quality management system requirements.

Suggested Sections

1. 1. Introduction: Overview of the facility, products, and purpose of the risk assessment

2. 2. Scope: Defines the boundaries of the risk assessment, including equipment, processes, and products covered

3. 3. Regulatory Requirements: Lists applicable regulations, guidelines, and standards being followed

4. 4. Equipment Classification: Categorization of equipment based on product contact, cleaning difficulty, and cross-contamination risk

5. 5. Process Overview: Description of manufacturing processes and cleaning procedures currently in place

6. 6. Risk Assessment Methodology: Explanation of risk assessment tools and scoring systems used

7. 7. Critical Parameters: Identification and analysis of critical cleaning parameters

8. 8. Contamination Risk Analysis: Detailed analysis of potential contamination sources and their risks

9. 9. Acceptance Criteria: Definition of cleaning limits and acceptance criteria

10. 10. Sampling Plan: Description of sampling locations, methods, and frequency

11. 11. Risk Control Measures: Detailed preventive and control measures for identified risks

12. 12. Monitoring Requirements: Ongoing monitoring and review procedures

Optional Sections

1. Product-Specific Requirements: Include when multiple products are manufactured in the same facility with different cleaning requirements

2. Automated Cleaning Systems: Include when automated clean-in-place (CIP) systems are used

3. Manual Cleaning Procedures: Include when manual cleaning is a significant part of the process

4. Cleaning Agent Assessment: Include when multiple cleaning agents are used or when there are specific concerns about cleaning agent residues

5. Environmental Impact Assessment: Include when cleaning processes have significant environmental implications

6. Cost-Benefit Analysis: Include when economic factors are important decision drivers in cleaning validation choices

Suggested Schedules

1. Appendix A: Risk Assessment Matrices: Detailed risk scoring matrices and evaluation criteria

2. Appendix B: Equipment List: Comprehensive list of equipment covered in the assessment with classification details

3. Appendix C: Cleaning Process Flowcharts: Visual representations of cleaning processes and decision trees

4. Appendix D: Sampling Templates: Standard templates for recording sampling data

5. Appendix E: Analytical Methods: Details of analytical methods used for residue detection

6. Schedule 1: Master Cleaning Schedule: Detailed cleaning frequencies and responsibilities for each piece of equipment

7. Schedule 2: Training Requirements: Required training modules and competency assessments for cleaning personnel

8. Schedule 3: Review and Update Schedule: Timeline for periodic review and update of the risk assessment

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Acceptance Criteria
Active Pharmaceutical Ingredient (API)
Batch/Lot
Bioburden
Carry-over
Clean Hold Time
Clean-In-Place (CIP)
Clean-Out-of-Place (COP)
Cleaning Agent
Cleaning Procedure
Cleaning Verification
Cleaning Validation
Cross-Contamination
Dedicated Equipment
Detectability
Dirty Hold Time
Equipment Train
First Rinse
Good Manufacturing Practice (GMP)
HACCP
Highest Allowable Carryover (HACO)
Impact Assessment
Last Rinse
Likelihood
Maximum Allowable Carryover (MACO)
Method Validation
Multi-Purpose Equipment
Non-Dedicated Equipment
Occurrence
Permitted Daily Exposure (PDE)
Process Flow
Product Contact Surface
Product Residue
Recovery Study
Residual Limit
Risk Assessment
Risk Control
Risk Level
Risk Matrix
Risk Mitigation
Risk Priority Number (RPN)
Risk Rating
Sampling Location
Sampling Method
Severity
Shared Equipment
Swab Sample
Therapeutic Daily Dose (TDD)
Toxicity Data
Validation Master Plan
Validation Protocol
Visual Inspection
Worst-Case Scenario

Clauses

Relevant Industries

Pharmaceutical Manufacturing

Medical Device Manufacturing

Biotechnology

Food and Beverage Production

Cosmetics Manufacturing

API Manufacturing

Contract Manufacturing Organizations

Research and Development Facilities

Healthcare Facilities

Nutraceutical Manufacturing

Relevant Teams

Quality Assurance

Production

Engineering

Regulatory Affairs

Validation

Manufacturing

Quality Control

Technical Operations

Environmental Health and Safety

Facilities Management

Research and Development

Documentation

Relevant Roles

Quality Assurance Manager

Validation Specialist

Production Manager

Quality Control Analyst

Manufacturing Engineer

Regulatory Affairs Manager

Process Engineer

Cleaning Validation Engineer

GMP Compliance Officer

Quality Systems Specialist

Manufacturing Supervisor

Cleaning Operations Supervisor

Health and Safety Officer

Technical Operations Director

Facility Manager

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Professional on-site risk assessment agreement compliant with Indonesian safety regulations and workplace safety laws.

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Authors

Alex Denne

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