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

Michelle Heiter

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

 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

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?

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.

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.

EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines

: Annex 1–Manufacture of Sterile Medicinal Products (2022 revision).

 Title 21, Parts 201 and 211. Current Good Manufacturing Practice for Drugs. 2023.

Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing

Chakraborty, S. and Baseman, H. Contamination Control Strategies: A Path for Quality and Safety. 

, May 8, 2022, pda.org/pda-letter-portal/home/full-article/contamination-control-strategies-a-path-for-quality-safety (accessed Jul. 21, 2025).

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

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Vol. 49, No. 7
September 2025
Page: 34

When referring to this article, please cite it as Heiter, M. and Schniepp, S. Effectively Using Contamination Control Strategies.

Articles

A contamination control strategy (CCS) is essential in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and operational efficiency. It aligns with EU and US regulations and ICH guidelines, focusing on minimizing contamination through good manufacturing practices. Key elements include monitoring, validation, contamination controls, and personnel management. A risk assessment is crucial for identifying and prioritizing contamination risks, fostering continuous improvement, and maintaining regulatory compliance. A robust CCS enhances product quality, patient safety, and company reputation by proactively addressing contamination risks.

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.