Eliminate Contamination Risks Before Your Next Inspection.
Full CCS review, gap closure, and documentation updates, delivered fast by contamination control specialists.
We have a suite of services to Educate, Execute and Elevate your contamination control program.
In fact, we can have your audit-ready Contamination Control Strategy complete in as little as 6 weeks.
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CONTAMINATION CONTROL
CONTAMINATION CONTROL Services for Pharmaceutical & Biotech Manufacturing
Contamination control is central to everything we do, and pharmaceutical manufacturers need to assess all potential microbial entry points. We assist pharmaceutical companies in developing robust Contamination Control Strategies across their entire operation to align with the new requirements of EU Annex 1, including GMP contamination control audits and remediation plans for:
Facilities and Equipment
Manufacturers need to understand the risks posed by their facility layout, cleanrooms, HVAC systems, airlocks, and equipment. We assist in identifying and prioritizing these risks as part of an integrated pharmaceutical quality system, ensuring compliance with sterile manufacturing contamination control expectations.
Personnel
The contamination potential due to personnel is minimised through a combined approach of awareness programs, GMP training, gowning qualification, and operator monitoring. We also offer specialised GMP contamination control training courses designed to enhance operator compliance in high-risk environments.
Utilities
Utilities (water, steam, and gases) form a critical part of the process and product quality. We help ensure your pharmaceutical quality management system includes comprehensive risk assessments and control strategies for clean utilities to prevent microbial contamination in manufacturing.
Raw Materials and In Process Control
Raw Material (RM) specifications must be in place for all GMP supplies and consumables, with risk-based release checks upon receipt. Procedures should state how the material is identified, inspected and accepted or rejected. These controls align with GMP contamination control best practices in the pharmaceutical industry and help mitigate supply chain risks.
Product Containers and Closures
Product containers, particularly final fill containers, pose a significant risk to patients if not handled correctly. Our pharmaceutical consultants assist in developing handling procedures that reduce contamination risks and ensure compliance with Annex 1 pharmaceutical contamination control requirements.
Vendor Management
Supplier Assurance ensures that GxP materials, equipment and sub-contracted services are purchased from approved supplier and that all new suppliers are assessed in a controlled manner. It should also define requirements for vendor audits and corrective actions as part of your contamination control strategy.
Outsourced Services
Suppliers of services (test houses, subcontractors, service providers, and distributors) should be assessed using a risk-based approach, with a focus on compliance issue remediation and maintaining GMP contamination control standards.
Process Risk Assessments
A Microbial Control FMEA (Failure Modes and Effects Analysis) assists manufacturers in identifying potential microbial entry and proliferation points as part of their contamination control quality systems remediation strategy.
Validation
All validation activities should be documented in the Validation Master Plan. Systems must be validated in accordance with EU Annex 15, EU Annex 11, and US FDA 21 CFR Part 11 requirements. This includes facilities, utilities, equipment, process monitoring systems, temperature control units, and shipping validation, supporting robust GMP contamination control remediation plans.
Maintenance and Calibration
Maintenance and calibration activities should be performed either in-house by trained staff or outsourced to vendors who have been approved under a structured Supplier Management Program, ensuring adherence to pharmaceutical contamination control system requirements.
Cleaning and Disinfection
Facilities must have comprehensive cleaning procedures to maintain a high level of environmental control. Our team assists with developing GMP cleaning and contamination control strategies to meet sterile environment standards, reducing the risk of contamination.
Monitoring Sytems
Validated monitoring systems must be in place to track viable and non-viable particulate matter within cleanrooms, particularly in Grade A/B areas, as part of your overall contamination control program.
Detection and Prevention
Internal and external GMP audits, trend analyses, and Corrective and Preventative Actions (CAPAs) are essential to detect and prevent non-compliance and potential contamination events. We also provide support in GMP contamination control remediation to address audit findings effectively.
Continuous Improvement
An important aspect of contamination control is transparent quality management oversight so that the senior leaders in the organization can pre-empt potential contamination issues. Key Performance Indicators (KPI's) and a culture of continuous improvement ensure high pharmaceutical contamination control compliance levels.
