Comprehensive Pharmaceutical Due Diligence Checklist for Quality & Compliance

Ensuring quality, safety, and regulatory compliance is essential for any pharmaceutical business—whether you are acquiring a facility, partnering with a contract manufacturer, or expanding your product portfolio. A well-structured Pharmaceutical Due Diligence Checklist helps companies evaluate operational efficiency, identify risks, and ensure adherence to global standards like WHO-GMP, USFDA, and EU-GMP. This guide provides a complete overview of what to review during pharmaceutical due diligence.

1. Regulatory Compliance Verification

Regulatory compliance is the foundation of due diligence. Companies must ensure that all operations, documentation, and processes meet applicable guidelines.

✔ Valid manufacturing licenses

✔ WHO-GMP, GMP, ISO certifications

✔ Compliance history: inspections, audit reports, past regulatory warnings

✔ Environmental and safety compliance (EHS)

✔ Validation and qualification documentation (IQ/OQ/PQ)

This step ensures that the manufacturer follows all critical legal and regulatory frameworks before collaboration.

2. Quality Management System (QMS) Assessment

A strong QMS ensures consistent product quality and minimizes risks.

✔ SOPs for all operations

✔ Change control system

✔ Deviation and CAPA management

✔ Internal audit processes

✔ Vendor qualification procedures

✔ Batch manufacturing records (BMR/BMR)

Evaluating QMS provides clear insights into how well the company manages quality and risk control.

3. Manufacturing Facility & Infrastructure Review

Infrastructure quality directly impacts product consistency and safety.

✔ Equipment qualification and maintenance logs

✔ HVAC systems, cleanroom classification, and contamination control

✔ Water purification systems (RO, WFI)

✔ Segregated storage for APIs, RM, PM, and finished goods

✔ Calibration of instruments

This section helps assess whether the facility can meet production demand and adhere to international GMP standards.

4. Supply Chain & Vendor Assessment

A reliable supply chain safeguards product integrity from raw material sourcing to delivery.

✔ Vendor audits and approval processes

✔ API and excipient testing reports

✔ Packaging material quality standards

✔ Inventory management system

✔ Transportation and cold-chain capabilities

This ensures that all materials used meet quality requirements and traceability.

5. Product Portfolio & Technical Documentation Review

Every product should have complete, traceable, and updated documentation.

✔ Product dossiers (CTD/ACTD format)

✔ Stability study data

✔ Specifications and analytical methods

✔ Validation reports (process, cleaning, analytical)

✔ Tech transfer documents

A well-documented system reflects transparency and process robustness.

6. Financial & Operational Risk Assessment

Operational efficiency and financial stability are equally important.

✔ Production capacity and utilization

✔ Cost of production & overhead structure

✔ Procurement cost analysis

✔ Workforce training records

✔ Risk management programs

This step helps evaluate sustainability and long-term profitability.

7. Intellectual Property (IP) & Legal Review

Ensuring freedom to operate and preventing future disputes is critical.

✔ Patents, trademarks, and IP rights

✔ Licensing agreements

✔ Ongoing litigations or disputes

✔ Contractual obligations

A thorough legal check protects the partnership and product rights.

8. Technology & Digital Infrastructure Assessment

Modern pharmaceutical operations rely heavily on automation and digitalized systems.

✔ LIMS, ERP, or QMS software used

✔ Data integrity controls (ALCOA+)

✔ Cybersecurity measures

✔ Backup and disaster recovery plans

This ensures accurate, error-free, and compliant data management.

Conclusion

A robust Pharmaceutical Due Diligence Checklist supports informed decision-making, minimizes regulatory risks, and ensures consistent product quality. Whether you are partnering with a manufacturer or planning an acquisition, a comprehensive evaluation of compliance, infrastructure, documentation, and quality systems is essential for long-term success. By following this structured checklist, pharmaceutical companies can maintain high standards of safety, reliability, and global compliance.

Knors Pharma remains committed to supporting the industry with advanced quality practices and complete transparency in compliance systems.

Also Check: https://knorsphrma.wordpress.com/2025/05/30/importance-of-due-diligence-in-the-pharmaceutical-industry-for-compliance-and-growth/