Effectively Using Contamination Control Strategies

Q. What is a contamination control strategy (CCS) and how does it support sustainable compliance and continuous improvement?

A. A CCS is required in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and efficient operations. The updated EudraLex, Volume 4, Annex 1 (1) mandates a CCS for sterile manufacturing in the European Union, aligning with similar FDA requirements
(2, 3) in the United States, as well as International Council for Harmonisation (ICH) Q9 Quality Risk Management (4) and ICH Q10 Pharmaceutical Quality System (5) guidelines.

A review of FDA 483s and FDA Complete Response Letters (CRLs) highlights areas for improvement in pharmaceutical manufacturing. Citations have been issued for deficiencies related to microbial contamination, environmental monitoring, and aseptic practices. Addressing these observations is required for drug approvals and to strengthen a CCS.

A CCS is a holistic approach to minimizing contamination by evaluating good manufacturing practices (GMPs). A CCS provides a proactive method for identifying, controlling, and scientifically evaluating quality risks designed to reduce contamination and enhance product safety and quality.

Elements of a CCS include the following (6):

• Monitoring controls—personnel, in-process, materials, environmental, utilities, and pest controls

• Validation controls—qualification/requalification of personnel, process, analytical methods, facility, utilities, and equipment
• Contamination controls—personnel training, hygiene and gowning, process design, vendor material, consumable containers, equipment design, cleaning and sanitization
• Personnel awareness/quality culture
• Quality risk management and risk assessment identify potential contamination sources and assess their impact on product quality and safety
• Scientific and technical knowledge to prevent contamination
• Personnel management to empower personnel through training. Staff education, awareness, and skills play a crucial role in maintaining contamination control.

A strong CCS serves as an invaluable quality tool, ensuring regulatory compliance while safeguarding product quality, safety, and enhancing the company’s reputation. Let’s embrace its power!

Q. Why is a risk assessment required for a CCS?

A. Conducting a risk assessment is critical for a successful CCS. It helps to proactively identify contamination sources and their effects, enabling implementation of targeted preventative measures that safeguard both products and the well-being of patients.

A risk assessment is key to:

• Identify hazards and risks before they turn into real problems.
• Prioritize control measures based on the severity and likelihood of each risk to enable the allocation of resources to the areas vulnerable to contamination.
• Regulatory compliance and a commitment to product quality and safety are essential for meeting regulatory standards in our industry.
• Fostering continuous improvement by gathering insights, streamlining processes, and embracing innovative technologies. A proactive approach reduces risks and drives growth. This approach enables us to maintain control at every stage of the product lifecycle.
• Encouraging a culture of safety that involves cross-functional team members in the risk assessment process. This approach helps everyone understand and take responsibility for contamination control.

A robust CCS begins with a risk assessment. By proactively identifying and addressing contamination risks, we improve product quality, prioritize patient safety, and confidently meet regulatory standards.

References

1. European Commission. EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines: Annex 1–Manufacture of Sterile Medicinal Products (2022 revision).
2. FDA. Code of Federal Regulations Title 21, Parts 201 and 211. Current Good Manufacturing Practice for Drugs. 2023.
3. Parenteral Drug Association. Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (PDA, 2023).
4. ICH. Q9 Quality Risk Management (ICH, 2005).
5. ICH. Q10 Pharmaceutical Quality Systems (ICH, 2008).
6. Chakraborty, S. and Baseman, H. Contamination Control Strategies: A Path for Quality and Safety. PDA.org, May 8, 2022, pda.org/pda-letter-portal/home/full-article/contamination-control-strategies-a-path-for-quality-safety (accessed Jul. 21, 2025).

About the authors

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp, is distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company.

Article details

Pharmaceutical Technology®
Vol. 49, No. 7
September 2025
Page: 34

Citation

When referring to this article, please cite it as Heiter, M. and Schniepp, S. Effectively Using Contamination Control Strategies. Pharmaceutical Technology 2025 49 (7).