During the manufacture of medicinal products, accidental cross-contamination can occur as a result of the uncontrolled release of dust, gases, vapours, aerosols, genetic material or organisms. This can also be caused by active substances and other starting materials and products being processed concurrently found on equipment and the clothing of operators.
Due to the notable risk, certain classes of medicinal products have previously been required to be manufactured in dedicated or segregated facilities:
• Certain antibiotics;
• Certain hormones;
• Highly active drugs.
The purpose of cleaning validation is to ensure the safety of human patients and target animals that are exposed to residual active substances via medical products, as well as that of consumers potentially exposed to residual active substances. These active substances can be present in food of animal origin as a result of food-producing animals being treated with veterinary medicinal products such as antibiotics. The aim of this approach is to derive a scientifically based threshold value for individual active substances for the purpose of risk identification.
Determination of health based exposure limits.
The procedure of determination of health-based exposure limits for residual active substances will provide what is known as the permitted daily exposure level. This determination process must involve a number of components:
• Hazard identification by reviewing all relevant data;
• Identification of critical effects;
• Determination of the no-observed adverse effect level;
• Findings that are considered to be critical effects;
• The use of several adjustment factors to account for various uncertainties.
The most common risks that can occur while performing cleaning validation are that not all hazards will be identified, not all data will be taken into account which will influence the outcome of the identified risks, and that some of the various uncertainties will be missed.
What we offer
Adryan will support the client by assisting with the cleaning validation process. Adryan employees can assist in the reporting of the cleaning validation survey that has been conducted: correct reporting prevents an incorrect outcome from being used, which could pose a risk to product or patient safety, while a correct report will lead to a risk-based and science-based approach with less duplication of work.
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