Pharmaceutical Change Control Review and Approval Checklist
Change control is critical to maintaining pharmaceutical product quality through the product lifecycle. This checklist ensures changes are properly categorized, assessed for regulatory impact, validated, and approved before implementation.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Per Change Request
- Estimated Time: 30-45 minutes
- Role: Regulatory Affairs Specialist / QA Manager
- Total Items: 31
- Compliance: FDA 21 CFR 211.68 Change Control Concepts for Equipment, ICH Q10 Section 3.2.2 Change Management, FDA Scale-Up and Post Approval Changes (SUPAC) Guidance, EMA Variations Regulation (EU) No. 1234/2008
Change Description and Justification
Review change description and business justification.
- Change fully described: what is changing, from what to what?
- Business and technical justification for change documented?
- All affected products, batches, and processes identified?
- Implementation plan with timeline and responsible parties documented?
- Rollback or contingency plan if change creates unexpected problems?
Change Classification and Regulatory Impact
Classify change and assess regulatory filing requirements.
- Change classified as minor, moderate, or major per site procedure?
- Regulatory impact assessment completed for all approved products?
- Required regulatory filing type determined (supplement, CBE, annual report, variation)?
- Confirmed change will not be implemented before required regulatory approval?
- Comparability protocol required for biologics changes?
Technical Review
Document technical review by subject matter experts.
- Engineering or technical review completed?
- QA review completed?
- Regulatory Affairs review completed?
- All required cross-functional reviewers signed off?
- Quality risk management assessment (ICH Q9) completed?
Validation and Testing Requirements
Define validation and testing required before implementation.
- Validation or qualification requirements identified and scheduled?
- Stability testing requirements assessed for process or formulation changes?
- Cleaning validation update required for equipment changes?
- Analytical method validation or transfer required?
- All required validation completed with passing results before implementation?
Documentation and Training Updates
Identify and complete documentation updates.
- SOPs requiring update identified and revisions initiated?
- Master Batch Record updates required and initiated?
- Specification or testing procedure updates required and initiated?
- Training on changed procedures completed before implementation?
- Labeling changes required and approved per label control procedure?
Post-Implementation Review
Review change effectiveness after implementation.
- Change implemented per approved plan with no deviations?
- Post-implementation review planned and scheduled?
- First batch review after implementation completed successfully?
- Change control officially closed after all requirements met?
- Change captured in APQR data?
- Regulatory filing submitted per required timeline?
Related Pharmaceutical Life Sciences Checklists
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Why Use This Pharmaceutical Change Control Review and Approval Checklist?
This pharmaceutical change control review and approval checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for regulatory affairs specialist / qa manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per change request.
Ensures compliance with FDA 21 CFR 211.68 Change Control Concepts for Equipment, ICH Q10 Section 3.2.2 Change Management, FDA Scale-Up and Post Approval Changes (SUPAC) Guidance, EMA Variations Regulation (EU) No. 1234/2008. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Change Control Review and Approval Checklist cover?
This checklist covers 31 inspection items across 6 sections: Change Description and Justification, Change Classification and Regulatory Impact, Technical Review, Validation and Testing Requirements, Documentation and Training Updates, Post-Implementation Review. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed per change request. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Change Control Review and Approval Checklist?
This checklist is designed for Regulatory Affairs Specialist / QA Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.