We are sure you have heard of the importance of having a Cleaning Validation for a correct production environment but, if you have not, read further and find out how @RCREDOL can help you make sure there are no mishaps in your process.
The truth is, Cleaning Validation is the single most important feature of your process, essential for the owner of a drug product to allow you to produce it. The reason for this is that most pharmaceutical industries are multi-product areas and use a wide range of equipment. This alone demonstrates the importance of cleaning facilities and equipment, as avoiding cross-product contamination is mandatory when producing pharmaceutical products.
Nevertheless, you cannot have a procedure for each cleaning, to achieve Cleaning Validation. Instead, procedures must take into account all productive processes manufactured in the equipment and they must be integrated in your processes and a target of detailed inspection and data collection. Also, do not forget a strategy for the maintenance of procedures is needed, to allow for a validated production, in an efficient and cost-effective way.
Going into detail, the steps for cleaning validation include:
1. Calculation of cleaning limits, using the Maximum Allowable Carry Over (MACO) calculations
2. Assessment of the surface materials which require cleaning
3. Development and validation of an appropriate analytical assay method
4. Development and validation of the swabbing/rinsing procedure
5. Development of the equipment cleaning protocols
6. Sampling and analysis of swab samples
7. Calculation of results for swab recovery and surface area swabbed
8. Reporting the results in the desired format
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations. Whether you are continuing your production, adopting new standards or have a new product in the works, @RCREDOL can help you achieve the desired cleaning validation models for your productive facilities, by creating standard procedures and information for your company. We develop protocols as well as reports with your data, both for analysis and as proof of your Cleaning Validation system. This way, your production will be ready for customer inspections and regulatory audits, a crucial step for the continued production of pharmaceutical products.
Contact us and discover how we can help you achieve GMP and FDA ready Cleaning Validation protocols.
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