Our Services – Pharmaceuticals & Veterinary Medicine
Cleaning method validation and verification
Cleaning Method Validation and Verification Services Comprehensive Solutions for the Pharmaceutical and Veterinary Medicine Industries
In the pharmaceutical and veterinary medicine industries, as well as in other industries, such as biotechnology, and food production, maintaining cleanliness and ensuring the absence of contaminants in products is fundamental for product safety and efficacy. Good Manufacturing Practices furthermore require confirmation that cleaning processes are effective in the removal of active pharmaceutical product residues, cleaning agents to a specified level, to ensure patient safety.
At CEMAS, we understand that effective cleaning method validation and verification are critical to maintaining compliance and ensuring the safety and quality of pharmaceutical and veterinary products. Our teams provide comprehensive cleaning method validation and verification services tailored to meet the stringent regulatory requirements of both the pharmaceutical and veterinary medicine industries.
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What is Cleaning Validation?
Cleaning validation is a documented process that provides a high degree of assurance that a specific cleaning procedure will consistently control potential carryover of product, residues, or contaminants. It involves detailed planning, testing, and documentation to ensure that the cleaning process meets predetermined cleanliness criteria.
Our Cleaning Verification and Method Validation Services:
- Study Plan (Protocol): We create detailed, customised method validation protocols that align with industry standards and regulatory guidelines. Our team will conduct thorough recovery studies to confirm that residues can be accurately detected and quantified on your equipment surfaces.
- Validation Reports: We provide comprehensive validation reports that document the entire validation process, supporting your compliance with regulatory requirements.
What is Cleaning Verification?
Cleaning verification is the routine monitoring and testing conducted to ensure that cleaning procedures remain effective over time. While validation is a one-time initial process, verification is ongoing and ensures that the cleaning process continues to perform as anticipated.
Our Cleaning Verification Services:
- Routine Sample Monitoring: We offer routine cleaning verification services to ensure ongoing compliance and to detect any potential issues before they impact product quality.
- Analytical Testing: Our laboratories are equipped with state-of-the-art instrumentation for the precise analysis of cleaning samples, including HPLC, LC-MS and GC analysis.
- Documentation and Record-Keeping: Our team ensures thorough documentation and record-keeping for all verification activities, facilitating easy access during audits and inspections.
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
